DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
CENTER FOR VETERINARY MEDICINE
STAKEHOLDER MEETING
Wednesday, August 19, 1998
9:02 a.m. to 3:58 p.m.
Room 800
Hubert H. Humphrey Building
Washington, D.C. 20201
C O N T E N T S
Keynote Address
Linda Suydam, FDA Associate Commissioner
for Strategic Management.................................9 page
CVM Address
Dr. Stephen Sundlof, Director,
Center for Veterinary Medicine..........................16 page
Stakeholder Panel #1
Alexander S. Mathews, President,
Animal Health Institute.................................36
Jess Stribling, Executive Director,
Animal Drug Alliance....................................43
Dr. Elizabeth Curry-Galvin, Assistant Director,
Scientific Activities Division,
American Veterinary Medical Association.................55
Dr. Tom Burkgren, Executive Director,
American Association of Swine Practitioners.............62
Richard Wood, Executive Director,
Food Animal Concerns Trust..............................70
Questions and Comments from the Audience and Summation
of Major Points from Panel Discussion.....................76
Stakeholder Panel #2
Dr. Paul Sundberg, Director of Veterinary Issues,
National Pork Producers Council........................105
Kim Goss, Manager of Regulatory Affairs,
National Cattlemen's Beef Association..................111
Joel Brandenberger, Vice President,
Legislative Affairs, National Turkey Federation........116
Paul Rodgers, Director,
American Sheep Industry Association....................126
Betsy Sheenan, Executive Director,
National Aquaculture Association.......................130
Questions and Comments from the Audience and Summation
of Major Points from Panel Discussion....................137
C O N T E N T S (continued)
PAGE
Stakeholder Panel #3
David Bossman, President,
American Feed Industry Association.....................150
Randall C. Gordon, Vice President,
Communications and Government Relations,
National Grain and Feed Association....................156
Dr. Alan Hanks, President-Elect,
Association of American Feed Control Officials.........168 Dr. Robert G. Zimbelman, Executive Vice-President,
Scientific Liaison,
Federation of Animal Science Societies.................175
Dr. James Jarrett, Executive Vice President,
American Association of Bovine Practitioners...........185
Questions and Comments from the Audience and Summation
of Major Points from Panel Discussion....................199
Closing Remarks
Dr. Michael Blackwell, Deputy Director, FDA/CVM........209
- - -
P R O C E E D I N G S
DR. BLACKWELL: Ladies and gentlemen, can we take our seats, please?
Thank you, and good morning. I would like to welcome all of you to the Food and Drug Administration/Center for Veterinary Medicine's Stakeholders Meeting.
For those of you who do not know who I am, my name is Michael Blackwell. I am the deputy director at the Center for Veterinary Medicine.
We could not have chosen a better day to hold such a wonderful meeting. We worked real hard to order up the weather that you have enjoyed thus far this morning. Unfortunately, we have the blinds closed here, but I think we may be able to adjust that after the slide presentations, and we hope that for those who have traveled here to the Washington area that you will enjoy your visit, and that you will leave today feeling as fulfilled as we think we will by the end of this day.
The purpose of this meeting is to solicit views from our stakeholders, from you, on how we as the Center for Veterinary Medicine and the FDA can best meet our statutory obligations.
Under Section 406(b) of the Food and Drug Administration Modernization Act of 1997, the agency is required to consult with our external stakeholders. Following these consultations, FDA is to develop and publish a plan for achieving compliance with each of its obligations under the Federal Food, Drug, and Cosmetic Act. Inherent in that statement, then, is the reality that we are not doing all that we are obligated to do under the Act.
Before we begin, I would like to go over some details about this meeting. First, we will have presentations by Linda Suydam, who is our associate commissioner for Strategic Management, and Dr. Stephen Sundlof, the director of the Center for Veterinary Medicine. Ms. Suydam and Dr. Sundlof will provide you with the background for this meeting, and some of the challenges being faced by the FDA in general, as well as the Center for Veterinary Medicine in particular, in meeting our statutory obligations.
Next, we will have brief presentations by representatives of five of our stakeholder groups. These presentations will last no longer than 10 minutes each.
Wanda White, who is sitting right here, will indicate to the speaker that there is only 1 minute left by showing a yellow paddle, and that time is up by showing a red paddle.
I do not know what happens after the red paddle, if you are still talking, but I know her as the intimidator, and you are on your own at that point.
Just kidding, Wanda.
I do want to encourage us all, though, to stay within our time frames because we do have a full agenda today, and we would like to give everyone an opportunity to share information and to dialogue with us. If necessary, I will stand back up here at this podium, and I think we will be able to move on at that point.
After each of the stakeholder presentations, we are allowing FDA panel members 5 minutes to ask any clarifying questions. Now, I should point out that the FDA panel is here to gain an understanding of the feedback that you have for us. Therefore, they are not here to make a presentation, and certainly, they will not engage in any debates about any issues, and we ask that you respect them for that and that they will respect the job of the moderator to keep this meeting on point.
This is a meeting for you, our stakeholders, and therefore, we are interested in your opinions and not our own. We ask that you help us to meet that challenge as well.
After the five stakeholder presentations that will occur this morning and the questions from the FDA panel, we will be taking questions and comments from the audience.
We know that several stakeholders were interested in participating on a panel, but unfortunately, we could not accommodate you, due to the lack of time and getting everyone at the table today and in this meeting.
So what we will hope is that you will take advantage of the opportunity to speak during the time period after the panel discussions. To allow as many as possible to share their views, we are asking that the members of the audience speak for no more than 5 minutes. Again, Wanda will give you an indication at 1 minute left, and then a red paddle will be displayed if you have reached the full 5 minutes.
After we hear from the audience, I will also provide a brief topical summation of the major points from the panel presentation.
I might add that when the summation is given, the objective will be to make sure that we have captured each point, but I will remind you that this meeting is being captured by transcription, and so, never fear, we will, in fact, have all that you have shared. I believe we will get it right in the end, but feel free to, again, question if we have maybe missed a point during a discussion.
The lunch break is scheduled for 11:45 to 12:45, and there is a cafeteria, as many of you have already found it. It is located right on this floor. We will reconvene at 12:45 for the second and third panels, and at approximately 4:30, we will start with our closing remarks.
I should also point out that the bathrooms and pay telephones are also right out the door to my left here, and I believe they are all on the left as you go down the corridor.
Please remember that speaking at this meeting is not the only way to let us know your opinions and your views about how we can best achieve our statutory obligations. You may also submit written comments on this subject to the Food and Drug Administration's Dockets Management Branch.
I believe we had a slide that may have that information on it. It is going to be shared a little bit later.
If you have copies of your remarks with you here today, you can give them to Linda Grassie. She is in the back there, and she will be happy to receive your written comments.
Also, you can submit your comments by electronic mail to the Food and Drug Administration's Dockets Management Branch, and I believe we will be showing you that e-mail address as well a little bit later.
Without any further delay, I think we should get started with our program, and we will do so by first asking if Linda Suydam will come forward. Linda, again, is the associate commissioner for Strategic Management, and for those of you who may not understand what all that means, she is essentially in charge of this effort.
So, Linda, thanks for being here.
Keynote Address
MS. SUYDAM: Thank you, Michael, and thank you all for participating in this process.
It is my pleasure to welcome you to this meeting on behalf of the FDA, and to point out that this is the fourth in this phase of our series of engagements with stakeholders. This is a process that we are taking seriously, and while FDA has engaged basically in dealing with its stakeholders in the past in many different ways, I think this is the very first time that we have done so in such a structured mechanism.
We will be having, I want to point out, a meeting on September 14th that is an agency-wide meeting. This meeting will be announced in the FR tomorrow. It is open for comment today, and we are hoping to use the September 14th meeting as a mechanism for looking at themes that we have heard throughout all four meetings.
So I would encourage you to attend. If you have not been able to present your point of view, at one of the Center-specific meetings, I would ask that you sign up and register for the September 14th meeting.
As you know, and as Mike mentioned, Section 406(b) mandates that FDA consult with its stakeholders, and this is a task that we are taking very seriously.
We see 406(b) as an opportunity to listen to the people who are involved with FDA to gain knowledge about how we might do our job differently, and then we have the tough task of putting together a plan that will meet the six objectives of 406(b).
Those six objectives, which I have highlighted on the next few slides, include maximizing the availability and clarity of information about our process of review, and I think this is an area where we have in the past perhaps not been as open as we should be. We are trying to give a new transparency to all of our processes, and we are trying to let people know what it is that is expected of them and what the process might entail in terms of the timeliness. I think that is one of the objectives of the FDAMA law.
The second part is to maximize the availability and clarity of information for consumers and patients concerning new products, and I think this also underlies the belief in Congress that there is information that the FDA has that we need to get out to patients. We are looking for input into each of these objectives.
The next two relate to our post-market monitoring and inspection obligations and the scientific infrastructure of the agency. Both of these activities have suffered in the past few years with the agency resources being drained to support the Prescription Drug User Fee Act and the food safety and tobacco initiatives, and we believe they are critical to making this agency function in the most effective way.
The next two objectives relate to the timeliness of application review and the statutory obligations, and as Mike Blackwell mentioned earlier, we have to in the plan address why and how we are going to meet the statutory obligations that we have and how we are going to solve the backlog issues that we have.
This is, I think, a particularly daunting task and requires us to think creatively, to look at new ways of doing our job, and to look at ways of engaging people in the process that we have not done in the past. We are anxious to hear from other people about the ideas that you might have about how FDA can do its job differently.
In the message that we have that is on our web site, we have a message to FDA stakeholders. This message addresses the six objectives of the 406(b), but in addition, it talks about areas of concern that we and the agency have about our responsibilities in meeting our statutory obligations.
The first of these relates to adverse event and injury reporting. This is an area that we think we need to be doing more, and we are anxious to hear from people about how we can do that better.
The second is product safety assurance that I mentioned earlier. We are not presently meeting our mandatory inspection obligations. We need to understand how we can assure that products are safe and how we can maintain the level of resources that we have in this important function.
The third is product application review, which has probably gotten the most attention in the last few years in the FDA budget, and in fact, in the internal FDA management, in terms of managing the process, we have looked at ways to make processes more efficient. We have reinvented. We have redesigned. We have reached a point now where we think we have maximized what we can do internally. Perhaps we need to have some new ideas from the outside, but we think we have been fairly creative as an agency, and we now have to look at how are we going to meet the statutory obligations for these products that are not supported by user fees.
I think the Prescription Drug User Fee Act gave us resources in the prescription drug area, but it was at the expense of other FDA programs, and for those of you who may not understand that, it is because there is a required floor to the funding of that program. Therefore, if the agency sustains cuts in the budget process, other programs will take those cuts, and that is what happened within the FDA budget in the last 3 years.
We have four other areas that I have mentioned briefly and I would like to highlight again. The first is food safety. This is a Presidential initiative. It is an area where we believe we have not focused in the past and now want to put additional energy and resources to this agency, and hopefully more appropriated dollars. So we are looking for input into our food safety program.
We also believe that our outreach activities are critical and essential under Section 406(b) and the FDAMA in general. So we want to look at the outreach activities of the agency and how we can make those more efficient and effective.
Scientific infrastructure and research are the building blocks of this agency, and they, too, have suffered because of the resource constraints that this agency has. We need to make sure that we have the scientific expertise, that we have the research base that can help us assure that the products that we regulate are safe and effective.
Finally, tobacco, I am not sure with the recent court ruling that tobacco will remain an initiative of the agency. I think its legal status is in question at this point in time, but it was, in fact, an area of emphasis in our most recent budget.
The next two slides I would like to point out are indications of the agency's budget, and the important thing to highlight in these two slides is that while the agency's budget apparently looks as if it has increased significantly from 1993, it has, in fact, in the base activities of the agency, decreased. This has been a significant erosion of the agency's ability to do its job.
We have not met the level of inflation that we have had to meet in this budget, in the budget over the years, and we have had priority programs added to this agency with line item funding, which, therefore, dictated that certain amounts of money had to be spent on the Prescription Drug User Fee, the Mammography Quality Standards Act, food safety, and tobacco. These activities have, in fact, then eroded the base.
So what I think you will see--this is what the world sees from a visible point of view--you see that the agency's budget has increased.
What you really have is a shrinking FDA, and, in essence, the agency's budget has decreased in the last 6 years. So I would hope that you would take this message to heart and to understand that what we have been doing in terms of reinvention, reengineering, has all been done in a time of constrained resources, and we are not hopeful that as an agency, there will be an additional bolus of resources coming to us, but we do want you to know that this is the situation we face.
We think that we are at a critical juncture. There is a major gap between the resources that we have to do the job and the resources we need to do the job, and as a result, we need to understand what our priorities should be. We need to understand how we can meet the statutory obligations that we have with limited resources, and we must understand what we need to change in order to do that without additional resources, or we need to get more resources. So that is the dilemma that we have and that we are facing, and that we expect you to understand as you move into giving us the input on how we should do our job.
As I mentioned, we are taking this seriously. We have a docket number established. We are looking for your comments. We want to hear from you. The docket is both center-specific and FDA-general. So we can put your comments in, in the appropriate place.
This is the docket number, and as Mike mentioned, there are three ways for you to give us the information. These three ways are by mail, the traditional way. Send your comments into us by e-mail, and our e-mail address is listed on this slide, and then also online, we have the FDA web page which has a site for this particular activity.
I look forward to hearing from you. I look forward to hearing from you about the ideas you have. I want to tell you that the last three meetings have been particularly successful, and I expect this one to be just the same.
Thank you.
[Applause.]
CVM Address
DR. SUNDLOF: Thank you, Linda.
I am Steve Sundlof, and I am the director of the Center for Veterinary Medicine. I want to welcome all of you who took the time out of your busy schedules to attend this meeting. It is very important for us to get your input.
As Linda mentioned, we are in a period of shrinking budgets, and at the same time, our workload is increasing. We have new initiatives, and we are asking for your input as to how to prioritize those issues, assuming that we are not going to have additional funding, what can we do to meet the expectations of the public to the degree that we can.
So I am going to ask Dave Lynch to start the overheads. We can go directly to the next one, Dave.
So the problems that we are facing as a center are the same that Linda just talked about for the entire agency, and that is that we are in a period of decreasing resources, and at the same time, our workload is increasing.
We think this is a good thing that the workload is increasing. This is an exciting time to be in the Government. There are all kinds of new initiatives. The work is becoming more complex. We are seeing exciting changes that are occurring, but these changes require resources in order to maintain the kinds of quality of products that we review and regulate.
So let's go ahead and take a look at our budget over the pat 5 years. You can see that in 1994, we were doing pretty good, and even better in '95, but in '96 and '97, our budgets have declined. In 1998, we had a further reduction, with the exception of that green bar up there which is the food safety initiative.
The food safety initiative, as Linda also pointed out, is one of those mandatory functions that we have to budget separately. It is an area that we are extremely grateful that we were able to participate in and did receive funding for because it is really going to allow us to address some of the critical issues that CVM is facing, especially in the areas of antimicrobial resistance.
Without this kind of an influx of money, we just could not do the kind of job that we think is going to be necessary to be protective of the public health.
So we are engaged in this activity, the President's food safety initiative. It is a national program. We are doing national surveillance of resistance of certain foodborne microorganisms that we think would be potentially harmful to public health if resistance to antimicrobial is developed in those organisms. We need a lot of research. I think everybody is aware that in this new age of food safety, where we are dealing with microorganisms and emerging pathogens, that there is a lot of research needed, how do you detect these organisms in food, for instance.
So there is a research component that will support our regulatory activities, but all of this money is very closely earmarked for specific activities that were outside of our normal CVM functions. In fact, we have a separate budget to make sure that those are kept separate. So the increase in the food safety initiative money cannot be used to supplement our regular work.
So, if you look at our budget, then, from '95 to '98, we have taken a 22.5-percent reduction in our budget, and that is in real dollars. That does not account for inflation and cost-of-living increases and other things.
So why have we had this decline? Well, for one thing, under the present administration of reinventing government, there has been downsizing of Government and streamlining. We do not have a victim mentality about this. We recognize that this was an important process and one that really forced us to look at the efficiency in our productivity and determine what is the best way to continue on in face of declining resources.
We are certainly no different from any other branch of the Government. Many of the other branches of Government have taken much greater reductions than we have, but we did have to downsize and streamline. Hopefully, we are past that point right now.
Flat-line budgets that Linda Suydam mentioned, in which there is no additional funding, the amount that we have remains pretty much the same. Yet, we are highly invested in salaries.
In fact, approximately 70 percent of our budget goes for salaries, and there is a mandatory cost-of-living increase for Government workers. So, when you flat-line the budget and 70 percent of that budget is for salaries, that means that all of the reductions to account for the increase in salaries and inflation, et cetera, have to come out of the remaining 30 percent of our operating budget. So that takes a significantly greater decrease when you look at it that way.
Also, Linda mentioned the user fee protections. I will just repeat somewhat what Linda already talked about, and that is that when user fee law was passed, the Prescription Drug User Fee Act, it said that appropriated funds still have to pay for the same amount that they did prior to that; that the user fees were an additive program, and that in order to protect that review process, in other words from the user fees totally funding that review process, the Congress said that you have to maintain a level base of appropriated dollars.
What that means is that when there is reduction in the budget, the PDFUA or the user fee dollars, appropriated dollars, have to remain the same. So all of the decreases come out of everything that is not a user fee budget, and that has affected CVM because we do not have the user fee appropriations right now.
So let's talk about some of the expanding workload that we faced in the recent years. First of all, we have had a growth in traditional work, and I will talk about all of these issues separately.
We have had a number of unfunded mandates, the increased complexity of the products that we are regulating. We have some brand-new initiatives that we are involved in, such as the food safety initiative, and we have some unexpected high-priority work, the things that cannot be anticipated and all of a sudden faced with falling in your lap.
In terms of the actual numbers, premarket submissions have grown by approximately 33 percent in the last 5 years. If you look at that over time, that really comes out to be about a doubling of the workload in about a 12-year period. This is, again, with no increase in budget; in fact, a decrease.
The DERs, which are drug experience reports, that we have received annually, that we by law have to receive annually, have increased by more than 180 percent in the last 5 years. These require a lot of time to process.
Adverse drug experience reports--those are the reports where there is an adverse effect that gets reported back to the Center--that we have received has increased by more than 250 percent in the last 5 years. That does not mean that our products are not safe anymore. It means that we have required a lot more focussed reporting in some of the product areas where there has been a lot of attention. For instance, in the area of bovine somatotropin, we require quite a lot of reporting back on that product.
Also, as we approve new blockbuster products that are distributed widely and have big markets, we get more reports in. So those are some of the things that have contributed to that.
We have had a number of unfunded mandates as well. One of them, the most recent one, is the Animal Drug Availability Act. I guess that is not the most recent one. The Food and Drug Modernization Act is the most recent one, but last year, we went through our modernization act, or 2 years ago, we went through our modernization act, and that requires us to write a number of new regulations. It requires us to reengineer some of the processes by which we approve drugs and regulated drugs, and that has taken a lot of the resources out of the areas, especially those areas of product review.
The FDA Modernization Act, we have some additional mandates under the FDA Modernization Act, and the Animal Medicinal Drug Use Clarification Act, that, is the Extra Label Drug use Act of 1994, required additional resources from CVM in order to make sure that that was implemented properly.
We have also experienced an increase in the complexity of the products that we regulate. Our recombinant bovine somatotropin was our first product that was a drug produced by biotechnology. There were a number of complex issues that we had to deal with in the process of going through the approval process.
We have also recognized that some of the issues are not adequately dealt with in the preapprove phase; that in addition to having good programs for preapproval of drugs, that having post-approval marketing studies is very important in many cases as well. So we have established some very intricate post-approval monitoring programs that we have to continually monitor and make sure that those are running on track.
Where we are moving more and more into the area of risk assessment, to better define some of the areas that may impact on public health as we approve new products that do not meet the traditional studies that we have had in the past. They require new kinds of thinking in order to make sure that the public is adequately protected.
So we are going through a learning process. Risk assessment is a relatively complex and new area for most of the regulatory agencies, and it is a rapidly evolving area. So it takes a lot to learn, and then also to keep up with the new risk analysis initiatives.
We have also undertaken a number of new initiatives. As I have indicated earlier, we had the President's food safety initiative, which is designed to reduce foodborne disease, and, again, CVM's mission under the food safety initiative is almost exclusively to deal with the problem of antimicrobial resistance. That is the second bullet there.
Putting in whole new infrastructures, setting up whole new monitoring systems, for years and years we worked with the USDA's Food Safety and Inspection Service to have an adequate monitoring program out there for detecting residues.
We now need a similar program to be able to detect antimicrobial resistance if it is going to emerge, and when it does emerge, and to be able to take the kinds of intervention activities that are going to be essential in order to safeguard the public. So that is whole new programs that we need to be developing.
With the Center for Food Safety and Applied Nutrition and the University of Maryland, we have now joined into a Joint Institute for Food Safety and Applied Nutrition in which we are utilizing the resources of the University of Maryland's number of departments there, including Veterinary Medicine, Chemistry, Agriculture, Food Safety and Nutrition.
A number of departments are trying to develop collaborative programs that will help us build the kind of infrastructure and obtain the kinds of scientific information that we are going to need as we move into the future to regulate some of these products and as new issues arise.
We are very active in the area of international issues as it pertains to the regulation of veterinary drugs. One of the questions that we are going to be asking you is whether or not we should be spending resources in this area. This is not directly tied to our mission, but it is very important for us.
The first activity, the international activities are things like VICH, which is the Veterinary International Cooperation on Harmonization. What that program is attempting to establish are similar criteria on a worldwide basis for preapproval drug submissions.
So, if a drug company sponsor wants to get a drug approved in the United States and in Europe and in Japan, for instance, the requirement should be the same. They should not have to repeat all the studies in slightly different ways in various countries. It is a way of harmonizing the requirements so that the studies only have to be done in one country, and they will apply across the board to other ones. That is important if we want to have more harmonization across the global marketplace.
We also have CODEX's Alimentarius, a subcommittee of the World Health Organization and the Food and Agricultural Organizations, and that committee is responsible for setting tolerances or the amount of residue that can occur in animal tissues on a worldwide basis. The purpose of that is to bring scientists from all over the world together to try an establish a single value for a safe level of a residue that can occur in foods of animal origin, such that one country cannot prohibit the import of products from another country based on the fact that their tolerance may be slightly different. So it is a way of harmonizing tolerances. Again, it is done to ensure free trade.
We think it is important that the United States be involved in that process so that we can ensure that when those worldwide tolerances are established that we are there reviewing the information that went into the establishment of that so that we have the assurance that those values of protective of public health.
We have also engaged in areas of strategic planning, as have all the centers within the Food and Drug Administration, and that is to make our processes more efficient, to make us more productive as an organization.
Finally, we are trying to change the culture of CVM through our high-performance organization process to make people have responsibility for the Center down to the very lowest levels of the organization so that everybody participates. We are trying to run this more like a business than a Government organization. It takes an incredible amount of time and effort to do this, but we think it is going to pay off very big in the long run.
We have had in addition, as all the centers have in FDA, some very unexpected high-priority work. Bovine spongiform encephalopathy is an example of an issue that was not anticipated, but yet required a considerable investment in resources from CVM.
Back in March of 1996 when the United Kingdom Spongiform Encephalopathy Advisory Committee announced that there was a high likelihood that there was a link between bovine spongiform encephalopathy in cattle and new variant Creutzfeldt-Jakob disease in humans, all of a sudden we were put in a position where we had to get some regulations out there. They had to be implemented in an extremely short period of time, and the issues were complex. Again, it took a lot of resources.
Antimicrobial resistance is another area that we have spent a lot of our time dealing with as these issues have become more important, such as the emergence of a new strain of salmonella, salmonella typhimurium DT-104 that is resistant to five antimicrobials already. That puts new emphasis and new pressure on us to make sure that we do not contribute to that problem.
You can see that our resources are dwindling because we could not afford a spelling checker for the word "resistance."
[Laughter.]
DR. SUNDLOF: Some of the efficiencies that we have tried to put in place to counteract some of the resource and workload implications are we are one of the reinventing government projects under the national performance review of the administration, and we basically redesigned the way that we approve new animal drugs. It is very innovative, and it is very interactive with the industry, such that it is kind of a just-in-time review.
We have broken out the application process into six major areas, and we are working with the pharmaceutical industries such that when they complete one section, we will review it at the time that they are conducting other studies. By this mechanism, we have reviewed the majority of their application by the time they finished all their studies. So it cuts down considerably on the amount of time lag after all of the review material has been submitted to the time that we can actually make the approval decision, yes or no.
It also saves companies a lot of time in that if we find issues during that process that we think need to be repeated or that do not need our criteria, we can let them know right then such that they do not have to wait until the very end and find out that they did a study wrong and then have to go back and repeat a number of different studies.
So that has been important. Again, we have been working very hard on our strategic plan to make us more efficient.
We have taken advantage of the technology to communicate better, as just about everybody has. We have taken advantage of the Internet and to local area networks, wide area networks, and all of the goodies that come along with that. That has very much impacted on our productivity, and we think that to the extent that we can afford these technologies, they have paid off very well.
We are into an area now where we are starting to look at electronic submissions, so that companies do not have to make several copies of these paper submissions which in some cases can fill up a small room, and also results in major storage problems for us which are expensive. Doing things electronically just makes a lot more sense.
Finally, I talked about the high-performance organization in which we are doing a lot of work to try and change the culture to be more businesslike.
Let's look at the reductions in our staff over the last 5 years, and I will start with the Office of New Animal Drug Evaluation. This is the office that is actually responsible for reviewing applications for new animal drugs and making the decision as to whether or not those drugs should be approved or not approved.
It has always been my philosophy that the best way to protect the public health is to make sure that we have a good process for evaluating the safety and efficacy of drugs, and that we use that in order to get products out onto the market, such that veterinarians and livestock producers have access to an adequate number of drugs to make sure that animal health is maintained.
We think that that is the best way to protect the public health because you get a lot of voluntary compliance. It promotes voluntary compliance to use drugs properly, to use drugs correctly.
We have a number of visible examples of how that has actually played out in the past few years. Where there have not been adequate drugs in the past, a lot of drugs were used off label. They caused residue problems. Now that we have new, safer, more effective drugs on the market, the tendency to use these other drugs is diminishing rapidly.
Knowing that we were going to take reductions in our work force, I tried to preserve this function because I thought it was probably one of the most important, but even with the efforts, there has been a 9-percent reduction in the staff in this office over the last 4 years. So we are taking reductions.
That is a 9-percent reduction just in the number of people who are involved in the review process, but we have all of these other issues, the unfunded mandates that I talked about, trying to get regulations to implement the Animal Drug Availability Act.
We have investment work where we are trying to write policies and guidelines to the industries, so that we have a more transparent system, so that we are more interactive and that we have a more stable regulatory environment. Those things take up resources.
So, in reality, what we have really experienced, because now all of the people that we are doing almost exclusively review work are doing these other functions that are necessary. We have actually experienced what we believe to be about a 36-percent reduction in FTEs, and for those who do not understand the FTE jargon, that stands for "full-time equivalents." That is equivalent to a one-person-year salary.
You can see that the yellow, again, is the amount of people that are available to do review work, and all of these other initiatives have really cut into that. Yet, we have more responsibilities than we can accomplish with the current staff.
As a result of that, our review times, which went down for about 2 years, we had a good reduction in the time that it took to review animal drugs, but about a year or 2 years ago, that hit a plateau and now it is going back up. The reason for that is apparent in this graph.
It is that we just do not have the resources that we used to, to be able to review this, even despite the efficiencies that we have built into the process. So that is our new animal drug review.
We have also taken some reductions in our research program. A lot of people would say, "Well, the research is probably the least important part of your function," but actually, we depend highly on research, very, very focused research to answer critical questions that are important for us to do our jobs, primarily relating to human food safety issues.
In many cases, we need specific information that just does not exist, and requires new research in order to produce that, which then is built right into the regulatory process. Then we can make sound scientifically based regulatory decisions.
As you can see, we have had a tremendous reduction in that over the past years in our extramural. That is research that we fund outside of CVM. It went from about a million dollars to almost nothing in 1998, except for the food safety initiative, which I said was very targeted and focused.
So, if you look at that without the food safety initiative, you can see that we have taken severe reductions in our extramural research.
In our Division of Compliance, this is the division in which we rely on our Division of Compliance to make sure that all of our laws and our regulations are being enforced, such that if there are people out there that elect to disregard the laws and the regulations, our compliance people make sure to bring those people back under the regulatory umbrella.
That is a very important function, and you can see from this graph that we have had a 42-percent reduction in our compliance activities.
At some point in time, you are going to get to an area where we do not have a credible enforcement program anymore, and once we do not have a credible enforcement program anymore, a compliance program, then we do not feel that we can adequately protect the public.
So it is important, and in fact, we are redistributing some of our resources to make sure that the Division of Compliance has adequate resources. They work very closely with the FDA field staff to make sure that all of the compliance actions are in place, but we do not have enough resources to make sure that we follow up on every single one.
They have also taken on new responsibilities as well in this process. It is not important that we go through all of the different colored bars, but as we rely on them to do other things, develop good regulatory policy, work with the field in order to make sure that there is a coordinated effort, it just becomes more and more of a drain on our resources.
So that is the context that I would like to present, as we ask you further questions today about how we can do a better job, where are the areas that we need to prioritize, what areas should we maybe not emphasize so much, so that we can meet the expectations of our stakeholders.
I would like to thank you all for giving me the opportunity to speak to you today as we go on in this meeting.
Unfortunately, I am going to have to step out for a little while. The National Academy of Sciences is going to, tomorrow, announce their results on whether or not there should be a single food safety agency, among other things, and they are having a prebriefing at 10 o'clock and I have been invited to go there.
So I am going to duck out for a little while, go to that prebriefing, and then I will be right back. Depending on what they say, the next time I talk to you, the initials may be different here. I am not sure.
[Laughter.]
DR. SUNDLOF: Thank you very much.
[Applause.]
DR. BLACKWELL: I would like to thank Ms. Suydam and Dr. Sundlof for their presentation and setting the context, the framework for our meeting today.
At this time, let us take a 15-minute break. We are going to get started in 15 minutes, and we ask that you quickly take your seats at that time.
Thank you.
[Recess.]
Stakeholder Panel #1
DR. BLACKWELL: Thank you for quickly locating your seats. We need to move into our next phase of this meeting.
I will do so by introducing our panels this morning. I would like to start with the panel to my right, our stakeholder panel, and starting from your right side of this table, as you are looking at it, we have representing the Animal Health Institute, Mr. Alex Mathews, president. Representing the Animal Drug Alliance is Mr. Jess Stribling, the executive director; American Veterinary Medical Association, Dr. Elizabeth Curry-Galvin, who is the assistant director of the Scientific Activities Division; the American Association of Swine Practitioners, Dr. Tom Burkgren, executive liaison; and Food Animal Concerns Trust, Mr. Richard Wood, executive director.
I would like to welcome all of you here this morning.
For the FDA, starting closest to me, we have Dr. Bert Mitchell, who is the CVM associate director for Policy and Regulations; Dr. Andrew Beaulieu, the deputy director for the CVM Office of New Animal Drug Evaluation. We also have Mr. Mike Thomas who is with our Office of Research, and Mr. Dick Geyer with our Office of Surveillance and Compliance.
We also have in the audience a number of people from the FDA who are here as resources in case there is need for clarifications from our side. In fact, those who are nearest to the front, I see a couple of names indicated on the placards here, Dr. Schwetz and Dr. Alderson.
They are here present in the audience. However, they will have to leave before the panel discussion ends, and they thought it might be a little bit disruptive to get up from this table.
So we hope you understand that, and with that, we should move right into the stakeholder presentations.
MR. MATHEWS: Thank you, Mike. It is a great pleasure to be here.
I am Alex Mathews. I am president of the Animal Health Institute. AHI represents manufacturers of animal health products, the pharmaceuticals, vaccines, and feed additives used in modern food production, and the medicines that keep pets healthy.
As a major stakeholder in the way FDA and the Center for Veterinary Medicine carries out its responsibilities under the Federal Food, Drug and Cosmetic Act, we welcome this opportunity to present our views on the agency's priority-setting and utilization of resources.
Let me first state that AHI greatly appreciates the close working relationship with CVM in achieving significant new legislation under the Animal Drug Availability Act, which preceded the passage of the FDA Modernization Act of 1997.
The ADAA was an example of a cooperative effort between the FDA and the Coalition for Animal Health, which resulted in sweeping changes in the way animal drugs are regulated.
It was only with the commitment of the Center that the Act was able to pass the many hurdles of the legislative process. We commend Dr. Sundlof and his staff for their strong support to this process.
However, the success of that undertaking could, indeed, be diminished if the spirit of the legislation is lost due to a failure to carry its objectives forward. AHI and the Coalition have relayed our concerns relative to key issues, such as the substitution of a multi-centered efficacy study to replace multiple investigations, a perceived reluctance by NADE to implement presubmission conferences, and little progress in developing workable regulatory solutions to enhance the availability of minor species/minor used products.
We trust that CVM will carefully consider these concerns so that ADAA can become the success that the industry, FDA, and the Congress expected.
In the short time we have today to comment on the wide array of questions posed by the FDA and the Center for Veterinary Medicine, I will focus on those issues of most pressing concern to our industry.
FDAMA mandated that FDA evaluate progress in addressing six objectives. We believe a key component of this evaluation is to ask what FDA can do to provide a more thorough and complete explanation of the agency's submission review process, and make explanations more available to product sponsors and other interested parties.
To this end, CVM is responsible for a drug approval process that must be science-based, predictable, and transparent. New policies are being implemented in the Center resulting in significant new requirements, especially for antibiotics, for which the industry has not been given adequate notice and opportunity to comment upon.
AHI urges the Center to address this FDA objective by following the regulations, policies and guidelines currently in place for product approval. Significant new requirements being contemplated by the Center should not be demanded of drug sponsors until the basis for such requirements has been formally communicated to the industry, and given an adequate public hearing and thoroughly grounded in science.
Another question raised by FDA is how to eliminate backlogs in the review process. AHI is concerned with reports from our members that suggest the approval process for new products has been experiencing problems resulting in the most significant delays in application review times in years.
We support an adequate level of funding to carry out all of the Center's public health responsibilities. However, it is necessary to prioritize those functions of most importance to the Center's mission and those of less importance where resources can be reduced.
The FDA/Center for Veterinary Medicine's mission statement as presented to stakeholders is to be a consumer protection organization fostering, and I quote, "public and animal health by approving safe and effective products for animals." We emphasize that this mission should be the guiding principle in allocating resources and priorities to the Center activities.
It is our view that the best way to protect the public health is to ensure the availability of safe and effective animal drugs and feed additives. We are concerned with the apparent redirection of priorities from product application review to other activities. We understand the Center has received both additional funding and additional responsibilities under the President's food safety initiative. While this is an important program, we fear that an increase emphasis in the Center on its potential role in microbial foodborne illness may interfere with its directive to evaluate the safety or efficacy of animal drugs and feed additives.
We urge CVM to direct the necessary resources to the drug approval process to maintain a system which is responsive and efficient in meeting statutory deadlines.
We are encouraged by the Center's willingness to implement a phased review system for new animal drugs. Phasing of the review process is important to both the agency and the industry by permitting a more logical step-by-step process for drug development and application review.
The industry strongly supports further efforts by CVM to incorporate phased application review as a routine procedure for NADAs.
A question has also been posed as to what functions the Center can contract out and whether it should impose user fees. Regarding the issue of user fees, AHI has steadfastly opposed user fees for NADA review. User fees or other forms of non-Federal funding are inappropriate for those functions that have the responsibility of Government and ensuring the safety of the food supply from foodborne hazards.
The industry is in no way opposed to the Center finding ways to improve or fill human resource gaps in its application review process by seeking expert outside review of certain sections of the application, as long as the quality of the review is maintained and review times are maintained.
For example, we would support the outside review of laboratory animal toxicology and pathology studies. Such studies are usually conducted under accepted protocols and outside scientific expertise as readily available.
Another potential area for consideration of outside expertise is with the statistical evaluation of efficacy studies, which is critical at drawing conclusions from well-controlled studies.
Let me also comment on enforcement of violations of the Food, Drug and Cosmetic Act. AHI views this function as critical in protecting the integrity of the drug approval process, and those pharmaceutical companies legally marketing products meeting the requirements of the Act.
We are concerned that the majority of effort and resources being expended by the Center on surveillance and compliance functions appears to be directed at these companies marketing approved drug products.
More effort in our view needs to go into preventing the distribution of illegally marketed or compounded products, and those practices which are clearly outside of the provisions of the recently published AMDUCA regulations, which restrict the extra label of human drugs in lieu of approved food animal drugs for which there is established safety and efficacy data.
I would like to commend briefly on a question posed by CVM regarding the mix of activities being undertaken in the Center Toward International Harmonization. While the international efforts listed in the question are important, AHI supports a strong focus on CODEX's Alimentarius and the Veterinary International Cooperation on Harmonization, the VICH initiative, as having the most importance to harmonization.
AHI and CVM have partnered closely in both the CODEX Committee on Residues of Veterinary Drugs and Food, and the VICH. These programs stand to be the most productive in our view in bringing science-based harmonization to the evaluation of new animal drugs because they are formal cooperative programs between the regulated industry and Government agencies in various parts of the world.
We thank you for your time today to provide some of our views, and we reserve our right to submit written comments in the docket by the September 11th deadline. We look forward to addressing these issues and challenges in setting priorities for CVM.
We strongly share Dr. Sundlof's goal of achieving higher levels of regulatory certainty and efficiency. All members of CVM have AHI's commitment to be a creative, positive force in developing solutions to the issues we face today and in the future.
Thank you.
MR. STRIBLING: Good morning, ladies and gentlemen. My name is Jess Stribling. I am an attorney in the Washington office of the Atlanta-based law firm of King & Spaulding, and I am here this morning in my capacity as the executive director of the Animal Drug Alliance, an association of companies that make animal health products, including generic animal drugs.
The Alliance is grateful to the Center for Veterinary Medicine for inviting its participation in this meeting, and I wish I could say that we come here with some magic bullets and solutions for what the Center is encountering.
I hasten to say from the very beginning that we have none. The Center, we believe, has been doing a very good and creative job in trying to do more on less, but it is impossible to do more on less. We all know that, and yet, we know that we live in a time when there is a so-called taxpayer revolt that makes it very unlikely that taxes are going to be increased. And we live in a time when both political parties are committed to downsizing the Federal Government. So we cannot just wait for another election in the hopes that things will get better.
It is a difficult situation. If there is anything different, it may be in the fact that whereas there have bene periodic downsizings of the Federal Government, not so with the private sector, except in the last few years when there has been significant downsizing. It may be that the private sector understands and, if I dare make such a quote, "feels your pain" in a way that it might not have been able to do in the past.
The Alliance has asked me to comment briefly on FDA Question 5 in terms of CVM and CVM Questions 1, 2, and 3, but, again, no magic bullet.
Question 5 asks what do you believe CVM should do to adequately meet the demands that are beginning to burden the application review process. Obviously, the simplest answer would be to have more people, and we would espouse that, though we are dubious about the possibility.
Secondly, given the fact that an individual or individuals have to review a new animal drug application, it is important that they not have material that they have to review that is not really necessary to make an approval decision. And the Center might look through its requirements, certainly Section 514 that establishes the categories of information, but it may be that over time, information has been required that is no longer necessary in light of new requirements and can be deleted.
There is, however, one significant kind of information that is part of the new animal drug review that more than anything else infuriate the feelings of members of the Animal Drug Alliance, and that is information that is reviewed by FDA field investigators, but is also required to be included in animal drug applications for a concurrent and duplicative review by somebody in the Center. Much of this is process validation information.
We recognize that there are different reviews that need to be made of this information. There is a scientific review, and there is a review for CGMP compliance, and we acknowledge that, but as we sit back and see the dwindling resources of the Center and the decline in number of reviewers, it just seems remarkable to us that there cannot be found some other way of doing both a science and CGMP compliance review of data other than having two separate people review the same voluminous stack of material.
For example, perhaps field investigators, who after all are intelligent and well-educated individuals, can be taught the science needed so that they can review these data sets from both the science and CGMP point of view, or if that is not possible, perhaps the Center scientists can give investigators a list of scientific questions. As the investigator reviews the data for CGMP compliance, he or she can mark the information that would answer the scientific questions.
Then the investigator can telephone the Center scientist and orally brief him or her on the answers. Do you see the point? There ought to be some way not to require two different people to review exactly the same information.
CVM Question 1 asks about the many consumer protection functions performed by CVM, and whether some should be changed. Admittedly, CVM's mandate is imposing and broad in scope. Its task is daunting, even with adequate resources.
We would, however, in concurring with our friends in the Animal Health Institute, express concern about the decline in the compliance efforts not only on the part of the Center, but also on the field investigators.
We agree with AHI that it is absolutely important for the Center's compliance activities to protect the investments made by animal health companies in the approval and the R&D required for approval of products.
We also look around and note that there are increasing number of inspections and increased requirements for animal health companies that are making products that are not under NADA process, and surprisingly little effort being made on those companies that are making products that are not under the NADA approval process.
Indeed, the Animal Drug Alliance has on several occasions cited specific companies by name to the compliance office of CVM asking that the CGMPs of those companies be reviewed because, so far as we know, there is some relatively gross situations in comparison with the standards that are being met by companies making approved animal drugs.
I would only add in passing that it is amazing how quickly we forget. I happen to believe that the human generic drug scandal, which then went beyond the generic industry to all FDA-regulated products in terms of a general non-compliance with CGMP and making products outside the approved applications, resulted from the preceding governmental deregulation, which had taken place as a political program and led to significantly decreased FDA enforcement.
In my mind, it was as simple as when the cat is away, the mice do play, and what happened was when FDA was not inspecting carefully, companies began to take shortcuts. "Be more efficient" is the euphemism, and as I say, that did not involve only the smaller companies, but it involved virtually every major manufacturer in the United States, human and generic, to some degree or less.
Just look through the names of the companies that were closed from time to time in both the human as well as the animal drug area.
Yet, here we are, just less than a decade away from the generic drug scandal, and we seem to be creating the same kind of environment by not allocating resources for compliance and for CGMP compliance that may lead to a similar-type problem. One wonders if that happens, what product area that will involve.
CVM Question 2 pertains to user fees and asks which FDA/CVM functions might be appropriate for user fees.
I must begin by saying that everyone in the Alliance agrees with AHI that it is not appropriate for the functions that are done by CVM to be funded anywhere outside the United States budget.
As a result, most of our members are against user fees, period, but there are a couple at least that say, "Well, things are so bad that regardless of what we think should be the case, we would be willing to consider user fees if we could be assured that there would be the same kind of results for animal drug approval times as there have been for human prescription drugs."
The difficulty, though, has been discussed this morning, both by Linda Suydam and by Steve Sundlof. User fees that are additive, such as those for human prescription drugs, may be fine, although they seem to have taken their toll on the remainder of the agency for reasons that Linda and Steve explained, but as I understand it, and please correct me if I am wrong, user fees that are being talked of now are compensatory in nature and represent nothing but the Congress allocating less money to the agency, but then being able to say that the agency is getting as much money as it did before, simply because it has user fees. That appears to us to be an opportunity for disaster, and we would like to know far more detail about exactly what kind of user fees are being talked about before we even take the time or make the effort to respond to such a question, much less consider it.
CVM Question No. 3 asks which activities could and should be outsourced, my word for third-party efforts.
We are perhaps more skeptical than our friends at AHI on this matter. We are somewhat uncertain about third-party efforts, and I think at this point, we would be happy to have CVM stand back and await the experience of other centers in the agency, or if it wants to try in a very limited way in terms of what AHI has suggested, that would be fine.
The issue, quite candidly, is whether third parties assisting in application review or performing CGMP inspections might not be more cautious in the case of reviewers or more stringent in the case of investigators.
Those of us who have dealt for years with FDA advisory panels, which are made up in many instances of academicians, are aware of the fact that while occasionally there will be an advisory committee that will go off and be far more liberal than FDA would have them do, by and large the problem seems the other, that there is always a little desire for a little more data, a little more information, and we are just not convinced that outsourcing is the way to go.
We are grateful, again, for the opportunity to talk with you this morning. We wish we had some magic bullets for you, but we will be happy to answer questions, as you have them, and to cooperate in any way that we can.
DR. BLACKWELL: We appreciate those comments from both the AHI and ADA.
We are going to change our format just a little bit and have the FDA panel, if you would. If you need to seek some clarification of any of the input we have received so far, if we can do that at this time, we will be directing this effort at both AHI and ADA. Then we will follow your discussion with the next presentation.
After each presenter, for the rest of the day, we will have this exchange take place.
Again, the effort to clarify, have the panelists clarify any of their comments in order for us to make sure that we understand the messages.
Dr. Beaulieu?
DR. BEAULIEU: For Mr. Mathews, could you clarify your perception of the Center's efforts with respect to approving the approval process for minor use products?
I think I heard you say that you thought we were divisioned in meeting that.
MR. MATHEWS: The concern there is essentially that we participate with the Coalition and have submitted some comments and concerns to you, and the feeling that we have is those comments perhaps have not been taken into account as well as they might have, so just to give you the due proper.
DR. BEAULIEU: Thank you.
MR. GEYER: My question is for Mr. Mathews as well, but Mr. Stribling might want to comment on it, also.
You made a brief reference to extra label use under AMDUCA. I wonder if you could elaborate a little bit on what you see as the problems and maybe solutions in that area.
MR. MATHEWS: The concern there really focuses back to surveillance and compliance, and the efforts that are being undertaken within the agency to focus on that and perhaps to take a careful look at how your resources in that area are focused. Are they directed towards companies which in our view are marketing properly? Are those companies that are perhaps distributing illegally or compounding improperly, whatever it might be? Just to really take a long, hard look at how you use your resources there.
MR. STRIBLING: I would only add to that another specific, which we have voiced to the Center of a violative activity, and that is the increasing number of veterinary compounding mail order pharmacies, many of which are compounding products that may be different in flavor or color from those that are made under the approval process by manufacturers and are direct competitors in a very violative way against companies that have invested in their approval.
MR. GEYER: Thanks, Jess, and one other question for you. You referred to the dual review for process validation information. The concern there is the amount of time that it takes, and if so, who much extra time, and also is there concern about consistency.
MR. STRIBLING: Thank you. There is concern about consistency as well.
MR. GEYER: And the amount of time, how much delay does that cause?
MR. STRIBLING: We have no way of knowing how much delay it causes because we do not know how much time it takes to review each dataset, at least inside the Center.
We can see how long it takes an FDA investigator to wade through some material, but given the time length of the approval process, anyway, we assume that anything that would shorten it would be helpful, and as we look at it, the notion of two people reviewing the same data just seems to us an inefficiency that we would attempt to address as a first order of business.
DR. BLACKWELL: Dr. Mitchell?
DR. MITCHELL: You both suggested increased resources to the review process and to compliance. I think it would be helpful to us during the course of the day if we could understand where you think those resources might come from, as well as the emphasis on where they should go. Now or later, I think it would be good to hear that.
MR. STRIBLING: Dr. Mitchell, I am told that the report from this meeting will go to the Congress of the United States, and so it seemed to me helpful for as many of us as possible to advocate increased funding of the Food and Drug Administration and the Center for Veterinary Medicine in order that the recipients of that report would hear widespread support for it.
MR. THOMAS: A question for Mr. Mathews. I thought I heard you say that you thought that the food safety initiative might pose a problem for the drug approval process.
MR. MATHEWS: It is a concern. It is a concern that resources, whether it be monetary or personnel, be taken away from the drug approval process to focus on the food safety initiative, and we will rely on your good judgment to see that it does not happen, but that is a concern that has been raised.
Let me also respond, if I could, to the resource question about user fees, and really to add to Jess' comments. We do as an association and as an industry oppose the imposition of user fees for the reasons we talked about and as I stated.
I think before you get to that question of whether you should or should not impose user fees, there are other questions that have to be answered really in the affirmative, and that is, are we administering, ADAA, the Animal Drug Availability Act, the Food, Drug and Cosmetic Act, in the most efficient way possible. Are we really thinking to do it in the smarter ways we possibly can from your side and candidly from our side as well?
I think if we go through all that, you come to the end of the line. You never say "never" in this town, but I think it is very important that we really go back because the ADAA was intended, I think, to try to address some of those concerns and to work it in a more efficient, I think resource-scarce environment that we are in now.
DR. BLACKWELL: Any other clarifying questions?
[No response.]
DR. BLACKWELL: With that, then we will ask if Dr. Curry-Galvin will come forward and give her presentation.
DR. CURRY-GALVIN: Good morning. My name is Elizabeth Curry-Galvin, and I am here today on behalf of the American Veterinary Medical Association.
The objective of the AVMA is to advance the science and art of veterinary medicine, including its relationship to the biological sciences, agriculture, and public health.
The Association provides a forum for the discussion of issues of importance to the veterinary profession, and for the development of official position statements.
The Association is the authorized voice for veterinarians, presenting its views to Government, academia, the media, agriculture, pet owners, and other concerned publics.
The reason I am speaking to you today on behalf of AVMA is because I staff the AVMA's Council on Biologic and Therapeutic Agents and its Drug Advisory Committee. These are the entities within AVMA who generally work with the animal drug issues and, hence, interact most closely with those members of the FDA/Center for Veterinary Medicine. I must say, we enjoy a very good working relationship.
Please let me take just a moment to introduce other members from the American Veterinary Medical Association with us here today. I have Dr. Nyle Finnegan, who is our newly appointed Government Relations Division director--thank you, Nyle--as well as Dr. Bernadette Dunham, an assistant director at this same Washington office.
Like others, the AVMA will be submitting our responses to the bulk of the questions asked by the FDA to the Dockets Management Branch, but let me take a moment and share maybe a few key questions. These were actually taken from the general FDA questions, and I have picked out Questions 1, 3, 4, and 5.
My stakeholder packet arrived promptly in Indiana. I live in Illinois.
[Laughter.]
DR. CURRY-GALVIN: So I focused more on those general questions which I was more familiar with.
In the first general question, the FDA asks what it can do to improve its explanation of the agency's submission review process.
Well, at first blush, I thought this seemed like a question really for the Animal Health Institute or the animal drug industry in general because the intricacies of the submission process are really the primary concern of animal drug sponsors.
However, veterinarians are highly concerned with the process' impact on drug availability. Clear communication and transparency of the process is paramount.
Implementation of the letter and the spirit of the Animal Drug Availability Act, particularly with respect to efficacy testing requirements, binding presubmission conferences, and minor use/minor species approvals must be uniformly welcomed by the Center.
The third general question asked by the FDA is really a long one, but basically gets to the heart of, among other things, how do you have an effective surveillance and compliance unit.
These functions are very important to the AVMA. We desire ongoing and enhanced support from the Center to answer questions related to extra label drug use by veterinarians. Generally, these questions involve the agency's evaluation of a situation and interpretation of its particular regulatory policy.
I as a staff member of AVMA can be very knowledgeable about AMDUCA, but sometimes questions arise and their interpretation of policy, and that is not something I can offer. I need to be able to hear good information from the Center. So I would ask you to continue to keep that a priority.
With regard to correcting problems associated with the use of FDA-regulated products, the AVMA mentions an area of concern, and that is the illegal distribution of prescription drugs to end users without authorization from a veterinarian in a valid veterinarian/client/patient requirement. The AVMA would like to see an enforcement presence on this issue.
Given the recent focus on postmarketing surveillance of antimicrobials used to treat food animals, the AVMA feels compelled to state that while we enthusiastically support improved antimicrobial susceptibility monitoring programs and company-sponsored monitoring, the goal must always be the retrieval of useful and scientifically sound information, with the recognition that the cost must not become so prohibitive so as to adversely affect drug availability.
In addition, we urge for transparent science-based discussions with stakeholders as the agency embarks upon evaluating the results obtained from these expanding monitoring programs and determining any corrective actions.
We look forward to active participation in these upcoming meetings that the Center has stated will take place.
To switch gears on Question 4, Question 4 asks what approach the FDA should use to ensure the appropriate scientific infrastructure with continued access to scientific and technical expertise.
We feel in this day and age of increasingly complex scientific issues, it is imperative that the Center has timely access to the best scientific expertise available. This is a foundation of good decision-making, and we recognize it costs money.
Question 5 asks about timely product reviews, particularly in the absence of user fees. In 1993, the AVMA approved a position statement that reads the AVMA supports user fees for new animal drug applications, only if such fees are directed toward enhanced review and approval of animal drug products.
It must be remembered, however, that the cost of user fees will ultimately be recovered in the purchase price of the drug when it is sold, and for our livestock and poultry industries in particular, the higher cost of drugs can offset the benefit of improved drug availability when a producer can no longer afford to purchase that drug. Thus, user fees are not a panacea would be my message.
So, in closing, the AVMA has examined the functions of the Center, and we do not see major areas where the Center should be divesting itself of responsibility. Instead, we are asking the CVM to deal with increasingly complex scientific issues, and we are awaiting many activities related to the ADAA and animal drug approvals and a number of surveillance functions. We see the need for the Center to receive more dollars to meet our expectations of our FDA.
I want to thank you for this opportunity to comment on behalf of the AVMA, and remind you of the standing invitation to used organized veterinary medicine as a resource in your decision-making and a conduit for your message.
Thank you.
DR. BLACKWELL: Thank you, Elizabeth.
Any questions from the FDA panel?
MR. GEYER: On AMDUCA, do you feel that you need more written guidelines on the implementation of AMDUCA? Should CVM be working on guidelines in this area?
DR. CURRY-GALVIN: I think I might not say guidelines.
What we have had in effect, the Center has worked very closely actually with myself as a staff person to feature those leftover questions during the AMDUCA satellite, and we have published in our journal of the AVMA four different issues that basically asks some of these questions and provide answers that the Center has cleared.
What I find is that we still have a substantial chunk of information that we need to keep putting through publication, and I know with the Center's distractions on a lot of different other important activities that there has not been as much emphasis on this.
So, basically, we have a mechanism in place, and if we could just have folks--and I think this is probably mostly surveillance and compliance that probably deals with most of this--if it is something they can prioritize to get information to me, so that we can continue to use the JAVMA journal as a vehicle for information to our members.
MR. GEYER: Thank you.
DR. CURRY-GALVIN: Thanks.
DR. BLACKWELL: Yes. Dr. Schwetz?
DR. SCHWETZ: Sorry, but I am one of the panel members who was not at the table.
What I would like to ask of you is to expand on your suggestion that we increase our access to the scientist and the scientific thinking that it takes to continue to do our job.
The AVMA is particularly important because you represent the crossroads of the veterinarians in practice, people in research, and in the regulatory community. If you can identify ways that we can be more innovative to have access to the scientist that it will take to make the decisions that we will be faced with over the next 5 to 10 years, it would be very helpful if you have some insights of how we can access those people without necessarily making them FDA employees.
DR. CURRY-GALVIN: Well, I do not have all the answers on that.
I guess what I would say is the AVMA would fee very comfortable exploring the concept that folks who provide useful information do not have to be FDA employees. So we would really embrace you reaching out to other groups, organizations, sources of this information to make sound decisions.
I am not familiar enough with the Government process to know what restrictions you have on that and such, but I would be happy to work as part of a mini working group or something to iron some of this out.
DR. BLACKWELL: Any other questions from the FDA panel?
Dr. Mitchell?
DR. MITCHELL: That was mine.
DR. BLACKWELL: That was yours, okay. Thank you.
Seeing none, then we will move on.
Dr. Burkgren?
DR. BURKGREN: I am Tom Burkgren. I am here representing the American Association of Swine Practitioners, which is a professional organization of approximately 1,300 members in the United States, veterinarians with an inviting interest in swine health and production.
I am listed in the program as executive liaison, although I have changed positions in the association. I am now executive director, which means I have more responsibility for the same money. So I can share the FDA's concern over unfunded mandates in their position.
As I went through the materials and prepared these questions, I found that the best starting place was the mission statement of the CVM. I found phrases in there that were important for my comments.
First of all, the CVM is a consumer protection agency. As food animal veterinarians, every time we stop on a farm, we are thrust into the role of consumer protection. We are also thrust into the role of protecting animal health. The second part of the mission statement for CVM was approving safe and effective products.
Access to those products by veterinarians and producers is essential for the continued health and welfare of the national swine herd. That is one of our main concerns.
I would limit my comments to the CVM-specific questions. First of all, Question 2, we have had a number of comments on user fees, and I share Dr. Curry-Galvin's concern over increasing cost, but I would also return, again, to the mission statement that if the FDA/CVM is a consumer protection agency, then in most cases what they do is for the benefit of the consuming public, and therefore, the consuming public should bear the cost.
Question 3, in terms of using third parties for certain functions, we have some limited experience of that in swine industry given the use of the veterinary feed directive and the contracting of inspections of those directives to State feed inspectors.
Just yesterday, I received an e-mail forwarded from a feed inspector that raised some questions about the valid veterinary/client/patient relationship and even some questions about the label of the product.
The questions were rather disturbing because this inspector is, in fact, inspecting feed mills as well as veterinarians in looking at VFDs. His questions displayed a distinct lack of understanding of the VCPR, which is very disturbing to me, but also a lack of understanding of the label.
He was concerned because he felt that the product was being used in a preventative manner, rather than a therapeutic manner, and we cannot get into the definitions, but, in fact, this product does carry a preventative label.
So, from our standpoint, if you are going to have third-party people doing these functions, then let's educate them because otherwise you are going to really disenchant a whole other group of veterinarians.
Question 4, the potential for collaboration, we feel that here we have the general themes of communication and education. We feel there is tremendous opportunities here as a veterinarian group to help with communication and compliance.
In the area of communication, as the Center tries to deliver messages to its customers, organizations such as ours have very well-developed and diverse methods of communicating and working with our members to help you deliver your message.
Also, in terms of establishing outreach initiatives, again, you can use our resources so we can help you to make sure that when you are targeting these initiatives that you use your limited resources in a better manner, meeting appropriate needs of the industry.
In terms of surveillance and compliance, with the antimicrobial resistance issues, as you develop the science of post-approval monitoring programs, we believe that the collaboration with the veterinarian scientific community on these types of programs will be essential if CVM truly wishes to establish science-based and transparent processes for drug sponsors to follow. We feel this is essential, again, for continued access to new antimicrobials.
In terms of field implementation to ensure the safety and effectiveness of products, organized veterinary medicine is where the action is. We have a tremendous wealth of information on how products are used in the field.
We feel that we can serve as a resource for the agency that if you come to us and discuss these things that we can give you guidance and help, again, in targeting proper use of your limited resources.
In terms of Question 5, on non-regulatory approaches, we would certainly welcome non-regulatory approaches. We feel that that can be a true strength of the agency in an innovative use of the organized veterinary medicine.
Again, to return to the issue of resistance development, as we look at the drug sponsors signing agreements to stop sale of new products if resistance develops, we would certainly like to see a more tiered approach rather than absolute withdrawal of a product from the market. If we can identify areas that are problems, that we use, again, communication and education of practitioners and producers to try to alleviate these, to instill voluntary recommendations on restrictions rather than regulatory approaches.
I would thank you for the opportunity to comment and certainly look forward to exploring new opportunities with the agency as we move forward in the swine industry.
Thank you.
DR. BLACKWELL: We appreciate that feedback.
FDA, any questions?
DR. MITCHELL: I would like to ask Dr. Burkgren if he would care to enlarge on his concepts of consultation, increased consultation between CVM and the agency. I think you were making reference to FDA field force, and heartier comments there.
Do you have a vision that you would like to articulate on how this might work, more so than you have had a chance to do?
DR. BURKGREN: I think probably just from the general theme of if there is a problem going on in the field, it goes both ways.
If we as a practitioner organization feel that the product is being misused or that needs action from the FDA, we should come to you, but, also, if you have questions about how products are being used in the field, you should feel free to be able to contact us to find out.
If we do not have the information, we can find out fairly quickly. We can contact our members. In the industry, we are a small industry, 1,300 veterinarians. We can get information probably quicker than you can.
I think that coming through us, our practitioner members would feel much less threatened for reprisals, for volunteering information. We feel that we can serve as a clearinghouse for communication both ways, from the FDA and down to the practitioners and back and forth.
DR. BLACKWELL: I have a question. Tom, regarding concerns that practitioners may have with respect to reprisals, could you expand that a little bit more? Is that from FDA or from other practitioners?
DR. BURKGREN: Probably both. Nobody likes to be labeled as a "snitch."
DR. BLACKWELL: Okay.
DR. BURKGREN: But I think also nobody likes to document their misdeeds. If they have questions and specific questions--the issue was raised about compounding veterinary pharmacies, where humans to these are not veterinary pharmacists. These are human pharmacists, and we are aware of what is going on. I get questions from practitioners that say, "Well, we have been told the FDA has signed off on this, and we are using these products, but now we are starting to wonder whether or not this is appropriate." They do not feel comfortable with calling the FDA because they actually do not want to document their misdeeds.
DR. BLACKWELL: Mr. Geyer?
MR. GEYER: I would like to ask you a question that I think perhaps Dr. Curry-Galvin might want to respond to, also. From the perspective of the practitioner, how are we doing on drug availability through drug approvals, through use through AMDUCA, through enforcement discretion, whatever? Are we doing better, worse, staying the same? What are your comments on that?
DR. BURKGREN: I think the general feeling is that you are doing better, and from a food animal practitioner standpoint, we do see new products coming for bovine. From the swine practitioner side, we are a little bit jealous. They have got more antibiotics than we have, and we tell them that they have a greater need.
I think that, in general, it is doing better. I think there is certainly a greater appreciation of how to properly use extra label products, but there is also the sense that they are perhaps freer to use those products in appropriate manners.
DR. CURRY-GALVIN: I guess I would have to echo that. That would be my take as well.
DR. BLACKWELL: Any other questions?
[No response.]
DR. BLACKWELL: With that, we will ask if Mr. Wood will come forward.
MR. WOOD: Thank you for the opportunity to identify priority issues as the FDA and the Center for Veterinary Medicine takes this step in response to the FDA Modernization Act.
I am Richard Wood, the executive director of Food Animal Concerns Trust, not "Animals." It is "Animal Concerns Trust," for whatever it is worth, or FACT.
FACT advocates for farm management systems that promote the safety of meat, milk, and eggs. We currently have over 30,000 individuals and supporters nationwide. We also sponsor a model egg farming system called Nest Eggs for the salmonella enteritidis control program on our farms since 1991.
In these brief comments, I want to address a couple of questions asked by the FDA and the Center for Veterinary Medicine, particularly, Question No. 3, which came in the mail to me first, too, and I kind of stopped there.
How can the FDA work with its partners to ensure that products are of high quality and provide necessary consumer protection? How can the FDA best establish and sustain an effective and timely science-based post-marketing surveillance system?
For us, this question raises issues related to the regulation of antibiotics that are used with food animals.
Thanks to scientific research, we now know that frequent use of antibiotics in animal medicine increases the pressure for the selection of antibiotic-resistant bacteria, and also increases the potential for this resistance to pass through the food chain to consumers.
We also know, thanks to the recent National Research Council report, that the jury is still out as to the magnitude of the risk, even though the report itself acknowledges that antibiotic-resistant bacteria can be passed from food animals to humans.
The 1997 World Health Organization report on the medical impact of the use of antimicrobials in food animals stated the following, "The magnitude of the medical and public health impact of antimicrobial use in food animal production is not known. Despite the uncertainty, however, there is enough evidence to cause concern. It is unrefused that the use of antimicrobials leads to the selection of resistant bacteria. Timely public health action is needed to control or mitigation any medical problem that might be related to the widespread application of antimicrobials outside the medical sphere."
So we call on the FDA and the CVM to take aggressive steps now to prevent food animal-related resistance from occurring in animal health.
We ask the FDA and its Center for Veterinary Medicine to take three steps. One, identify through a public process criteria for antibiotic approvals and the thresholds for antibiotic resistance. Two, secure from the animal drug companies information as to the quantity of antibiotics sold in the U.S. by label, and, three, to prohibit the use of antibiotic growth promoters that are also used in human drug therapy or that may impact human health.
We applaud the work of the Center for Veterinary Medicine, the AVMA, and the CDC for working toward prudent use guidelines for the therapeutic use of antibiotics in animals.
I was an observer at the May 5th meeting of the group that began to define the concept of prudent use. For what it is worth as staff for a consumer group, while we would like opportunity to comment at some point, it is the scientists and the practitioners who are sitting around that table who should craft that definition, but that is not to advocate responsibility for the role that the public should play.
The public has at least two important functions when it comes to defining how antibiotics are to be used with animals.
First, consumer representatives should be at the table along with the scientists and the other stakeholders to define the criteria by which an antibiotic is approved.
For example, should resistance testing be a part of the approval process? What kind of provisions are in place if resistance were to occur?
Second, consumer representatives should be at the table with scientists and other stakeholders to help identify the thresholds for antibiotic resistance. Based on the best science available, at what point of resistance is an antibiotic to be considered a threat to public health? We call upon the Center for Veterinary Medicine to facilitate such a decision-making process.
Secondly, we call upon the animal drug industry to make public their antibiotic sales information, and we call on the CVM to help enable this to happen.
The National Research Council report calls for the establishment of a national database to "monitor microbe-related illnesses and trends in antibiotic resistance that may result from drug use in food animals."
The database would help to determine the risks related to antibiotic use. We would welcome the establishment of such a database, but its information would be valuable only if the database contains complete and accurate information.
Health officials have indicated that a major obstacle in linking animal drug use to rising resistance is the lack of data on how much antibiotics are used in food production.
For example, how much serafloxin is being used in treating chickens? Regarding subtherapeutic drugs, licensed feed mills report the pounds of feed sold, but how much active ingredient is in the poundage indicated?
Industry may tell us that the data that will assist the agency in monitoring resistance is proprietary, but there must be a way around this concern, while at the same time providing the necessary data just as the pharmaceutical industry in the U.S. has been willing to release sales and volume data on antibiotics used in humans.
It is now time for animal drug manufacturers to do the same. Then antibiotic-resistance decisions can be more fully informed.
Finally, we call for a ban on subtherapeutic drugs that are also used in human drug therapy. While there is currently a great deal of discussion around therapeutic drug use, the discussion on subtherapeutic drugs in and of itself is not on the table, at least from our perspective.
Yet, in the literature, we read that 90 percent of all antibiotics administered to animals are used in subtherapeutic doses and not for the treatment of illnesses.
Until science demonstrates that subtherapeutic use of these antibiotics is safe, their use as growth promoters should be stopped.
The economic analysis of the National Resource Council found that banning growth promoters would have an adverse economic impact on producers and thereby on the cost of food for consumers, but the premise of that NRC study was a total ban on all antibiotics used subtherapeutically.
You may want to study the economic impact of the total ban that is going on in Sweden, but our organization is calling for a ban only on those antibiotics which are used in the treatment of human disease and those antibiotics that select for resistance in antibiotics used for humans.
As you know, this is not FACT's proposal, my organization's proposal. The World Health Organization both in 1994 and in 1997 called for a ban on subtherapeutic antibiotics and also antibiotics that were also used in human therapy.
All of the industrialized nations have adopted this ban, with the exception of Canada and the United States. On behalf of human health, it is time to take this step.
In terms of the CVM consumer protection functions, very quickly, as identified in the CVM questions, for us, obviously, the surveillance function regarding antibiotic resistance is key.
In terms of the agency's emphasis on non-regulatory approaches in its Question No. 5, we believe that a good model is the feed mill training that has taken place around the BSE regulation. Still, FDA and CVM is a regulatory agency, and we support functions that affirm this regulatory and inspection power.
We applaud the priority that CVM has given to monitoring implementing the BSE regulation, devoting primary resources to this effort. CVM's response to this rulemaking process was a good model of how the agency is to protect human health.
Finally, we affirm the outreach functions at CVM. The agency is and should be responsive to involving and updating all of its stakeholders including consumers in its policy and regulatory decisions.
Thank you for this opportunity to address these questions.
DR. BLACKWELL: Thank you, Mr. Wood.
Do we have questions from the FDA panel?
[No response.]
Questions and Comments from the Audience and
Summation of Major Points from Panel Discussion
DR. BLACKWELL: If not, what we will do at this time is open up our discussion to the audience, if any would like to make comments, to give us some feedback at this time.
We ask that you do use the microphone here in the center aisle so that we can capture that for our transcript.
You can direct your questions to us. We are asking, again, for clarification or feedback now in this case. If you have some specific feedback from your perspective that has not been mentioned, please take this opportunity to share it.
Yes, please. I think you are the fellow that told me I was going to be shot.
DR. DODEMAIDE: Thanks for this opportunity. My name is Robert Dodemaide. I work for Hoechst Roussel Vet, and I am speaking on my own behalf. I am not speaking on the industry as a whole or on behalf of AHI, of which our company is a member.
First of all, I would like to address user fees. Our company is against user fees, the imposition of user fees. We feel that the imposition of those will discourage us from applying for supplemental applications, for perhaps minor uses or less lucrative uses. It would only be a discouragement, especially for minor uses and minor species, and also, we look at the example of our northern neighbors where despite the imposition of user fees now for possibly 2 or 3 years or whatever it is, their approval process is still, I think, an utter disaster. It has not made one jot of difference to their efficiency or the approval process.
On the issue of improving efficiency of review, I would like to suggest that CVM look very seriously at outsourcing reviewing certain sections, and I think the human food safety section is a particularly good example of where this could be done.
The protocols under which studies are done are fairly standardized. There is a lot of expertise available out there, and I think this would greatly enhance the review process and the timeliness of reviews, and even perhaps protocols, if some of the reviewing was outsourced.
Moving onto manufacturing, I have a couple of comments here. I guess I would just like to urge that CVM ensures that there is no duplication in the review process. I think the potential for this is especially apparent in the CMC section of the submission where we have in-house and field people who both have a chop at this process. I think the potential for duplication there needs to be looked at, and the process needs to be simplified, I think, so as to avoid this.
Finally, I am talking now about post-approval updates to our manufacturing submissions or our manufacturing section of our approved applications. I think we now have several avenues to which we can submit updates and changes to our manufacturing process, and I think I would like to call on CVM to simplify this.
One suggestion I would like to make is to delete from the annual drug experience report the section which calls for any updates in the manufacturing. I would like to suggest that we simplify this by either having minor updates that would be submitted to the AAP process biannually, and if there is a major change, we submit a supplement to the NADA, therefore eliminate the annual drug experience report as an avenue for this.
I hope that just by having two routes to which we could send a manufacturing submission, this would simplify the process both for the sponsor and for the agency in trying to keep track of what is going on.
At the moment, we have some applications or some changes that are sent to ONADE and some go to surveillance and compliance. I think we need to simplify this and more neatly put it into a box, I suppose.
Thank you very much for this opportunity.
DR. BLACKWELL: Thank you very much.
Are there any questions from FDA for clarify?
[No response.]
DR. DODEMAIDE: Thanks.
DR. BLACKWELL: Thank you. Appreciate it.
Yes, please.
DR. LIEBERMAN: Hi. I am Patty Lieberman representing the Center for Science and the Public Interest.
The Center for Science and the Public Interest is a non-profit organization that since 1971 has been working to improve the public health. We are the largest consumer organization that is focused primarily on food issues, reaching more than a million North Americans with our publication, Nutrition Action Health Letter.
We recently released the report protecting the crown jewels of medicine, a strategic plan to preserve the effectiveness of antibiotics. We also note the formation of a coalition, the Campaign to Preserve the Effectiveness of Antibiotics, with more than 50 medical experts and 14 other health and consumer groups participating.
Despite the CVM's mission to protect the public health, that mission appears to have been unfulfilled when it comes to addressing the use of antibiotics in agriculture and the development of antibiotic resistance.
We recognize that in the 1970's, the FDA proposed halting subtherapeutic uses of two medically significant antibiotics, penicillin and tetracycline.
Unfortunately, but perhaps predictably, Congress intervened to protect the interests of agribusiness. Since that time, CVM has not addressed subtherapeutic antibiotic use, despite the increased evidence and broad concern in the medical community that those uses of antibiotics pose a human health risk due to antibiotic resistance in human pathogens.
It appears that the CVM is putting the burden on the public health community to prove that subtherapeutic uses are dangerous instead of industry to prove that the uses are safe, but human health concerns demand that the use of antibiotics in livestock be minimized to protect both animal and human health.
In recent months, many of the experts have urged action on agricultural uses of antibiotics. In February, Wolfgan Witte of the Robert Koch Institute stated in a commentary in Science, "In the future, it seems desirable to refrain from using any antimicrobials for the promotion of animal growth."
As exemplified by the use of virginiamycin in animal feed and the subsequent emergence of enterococci, resistant antibiotics, the use of any antimicrobial can lead to unexpected consequences that limit medical choices.
In May, Stuart Levy of Tufts University wrote in the New England Journal of Medicine editorial that recent findings have "made it even clearer that the use of growth promoters affects the drug resistance of environmental reservoirs with direct consequences for the treatment of disease in humans," and that "such findings led to a ban on avoparcin in the European Union countries and recently on virginiamycin in Denmark."
In July, a report of the National Academy of Sciences acknowledged that agricultural uses of antibiotics pose a risk to the public health.
In 1997, the World Health Organization held a meeting on the medical impact of the use of antimicrobial drugs in food animals. At that meeting, the WHO reinforced recommendations made by a previous WHO advisor group that stated, "The use of any antimicrobial agent for growth promotion in animals should be terminated if it is used in human therapeutics, or if it is known to select for cross-resistance to antimicrobials used in human medicine."
The FDA should adopt WHO's sensible position and immediately terminate the uses of penicillin and tetracycline which are used in human medicine.
The CVM also should ban the subtherapeutic use of tylosin and lincomycin which are related to erythromycin, and virginiamycin which is related to synercid.
WHO also stated that it is essential to have a systematic approach towards replacing growth-promoting antimicrobials with safer non-antimicrobial alternatives. The CVM should also adopt that goal.
The scientific community also has concerns about approvals of new antibiotics for therapeutic uses in livestock. The CVM should not approve for use in livestock important antibiotic classes such as fluoroquinolones that are life-saving in human medicine, especially when other antibiotics are just as effective in treating livestock infections.
If CVM does grant approvals for new antibiotics for livestock, it should require automatic withdrawal of the drug from the market if harmful antibiotic-resistant bacteria reach levels set by the FDA and CDC at the time of approval.
In addition, the CVM should require that manufacturers submit sales data, checking the amounts of the various antibiotics used in various species of livestock. Those data which should be publicly available would complement the surveillance data that tracks antibiotic resistance.
Regulators then could correlate antibiotic use with developing resistance in order to make the necessary policy decisions to protect the public health.
In sum, the use of antibiotics in agriculture jeopardizes the value of those precious drugs in both human and veterinary medicine. Drastically reducing antibiotic usage should be a top priority of the CVM.
Thank you.
DR. BLACKWELL: Thank you.
Maybe some of the panelists here with FDA can help out here. Is there a specific recommendation in addressing these concerns how we might, given the scarce resources, improve our ability to do all the things that you are suggesting?
I did not hear that, I guess. Could you comment on that? Is there a specific recommendation?
DR. LIEBERMAN: For what? For scarce resources?
DR. BLACKWELL: I think the context of today certainly has to do with the fact that we all know there are a number of things we need to be addressing, and the idea is, of course, how to best do that.
You have pointed to a problem that, as you see it, we need to address. I guess what I was trying to pull from your comments was whether there was a specific recommendation as to how we might achieve the resources to do those things.
DR. LIEBERMAN: What about to the FSI funding?
DR. BLACKWELL: Through the food safety initiative. So redirecting funds? Is that what I hear you saying? Okay.
Yes, please.
MR. MATHEWS: Mike, I know you do not want to turn this into a discussion about resistance, but I think there are a couple of points I just want to make on behalf of the industry, and also perhaps a suggestion to the agency in how you might approach to respond to your question.
We as an industry share the concerns that have been raised on this point, but I think that whatever decisions are taken or judgments made must be based on sound science and not supposition.
We strongly support educational efforts, increased research. We put our money where our mouth is on that. We are supporting work at Georgetown University on the resistance issue.
We are an active player and strongly support the work at AVMA and the practitioner groups in developing prudent use, judicious-used guidelines. For years, we supported following the label on dosage, but this goes a step further, to judicious use.
I think specifically you asked what could be done. I think you need to take a long, hard look at developing a nationwide post-approval monitoring program.
We talked before about company-by-company, but going on a national program, looking at that. I think that is where you can develop a strong data back to resolve some of the issues and questions that have been raised.
DR. BLACKWELL: Thank you.
DR. LIEBERMAN: May I respond to him?
DR. BLACKWELL: Yes. Now, a reminder. You know, I had one real assignment today, and that was to prevent debate.
I think what I just heard was one recommendation that would address your concern, and I would not call that a debate; in other words, a national program that would allow us to get some information that will then help us to take the appropriate actions.
DR. LIEBERMAN: I have comments.
DR. BLACKWELL: Okay, you want to make comments.
Before we go to the next set of comments, any other discussion or concerns, questions for clarification on what has been presented?
[No response.]
DR. BLACKWELL: Thank you very much.
Yes, please.
DR. RISSLER: Good morning. I am Jane Rissler, senior staff scientist at the Union of Concerned Scientists, an independent non-profit organization dedicating to advancing responsible public policies in areas where technology plays a critical role.
UCS advocates sustainable agricultural practices and policies to reduce agriculture's impact on the human health and on the environment and to ensure global food security into the next century.
I am also speaking this morning on behalf of Dr. Rebecca Goldberg of the Enforcement Defense Fund in New York, a 300,000-member, non-profit environmental group working on a broad range of regional, national, international environmental issues.
As stakeholders, along with those who develop, market, and use animal drugs, UCS and EDF are grateful for the opportunity to make these comments, and our comments touch on Questions 1 through 3 and 6.
Both organizations are just beginning to become involved in animal drug issues. The more we know and what we learned in a short time is that we are greatly concerned about the increase in antibiotic-resistant human pathogens and possible links to the use of antibiotics in food animal production.
We note CVM's initiative on antimicrobial resistance and urge the agency to make a major commitment to preserving susceptibility to antibiotics among human and animal pathogens.
While we appreciate the fact that animal production and antibiotic resistance are complex issues, we, nonetheless, believe it is time to closely scrutinize the use of antibiotics in industrial animal agriculture and aquaculture with two aims: to eliminate the uses that are least critical, that is, subtherapeutic uses; and to develop more non-drug solutions to growth promotion, prophylaxis, and therapy.
First, we urge FDA to release information on the kinds, amounts, and methods in places of delivery of antimicrobials used at both subtherapeutic and therapeutic levels to produce livestock, poultry, fish, and other food animals in the United States, and to release information on surveillance and monitoring of the use of antibiotics in animal agriculture and the emergence of antibiotic-resistant animal and human pathogens.
These data should be released in a form that is easily understood and readily useable by public health scientists and agencies such as the Centers for Disease Control and other stakeholders.
In response to your earlier comment, we would urge the industry to take the lead in making this information available, particularly the information on use of antibiotics, so that we could begin to look at the correlations between antibiotic use and antibiotic resistance patterns.
Second, in terms of Question 6, we urge FDA to move prudently in the review of new antimicrobials for animals.
While a backlog of animal drug reviews is important to veterinarians and others who want as many tools as possible in the challenge to produce animal food products, the tide has turned against antibiotics.
Rather than approving as many antibiotics as possible, it is time to reduce antibiotic use and search for non-drug solutions to problems of animal growth and health.
Thank you.
DR. BLACKWELL: Thank you.
Any questions from the FDA panel?
[No response.]
DR. BLACKWELL: Again, a quick question. What I think I heard was that in our seeking to share information about antibiotic uses and certainly in asking the industry to do likewise, there will obviously be a lot more known by all who are concerned about this issue, but I am still searching for the resource piece there. We want to make sure we do not lose that, if there is a resource point.
DR. RISSLER: I certainly appreciate the problem of resources at the FDA. This simply should be made a high enough priority if resources are put there.
DR. BLACKWELL: I am sorry. He cannot pick that up. Thank you.
DR. RISSLER: This is a serious enough problem that it should be such a high priority that you would not even ask me that question, that the resources would be put there from other less critical programs.
DR. BLACKWELL: Could you identify those for me?
DR. RISSLER: No, I cannot. I frankly cannot. I am new to this.
DR. BLACKWELL: That is kind of what we are trying to get today, though. We understand that there are a lot of priorities.
DR. RISSLER: Yes.
DR. BLACKWELL: What we want to do is make sure we hear from you as to which priority is higher.
Now, you have indicated what you believe is the highest priority, but that certainly would be at a cost.
DR. RISSLER: Yes, it certainly would.
DR. BLACKWELL: And we just need to identify those.
DR. RISSLER: Just as these other folks from industry have indicated what priorities are.
DR. BLACKWELL: Yes.
DR. RISSLER: You have not asked them to name low priority projects. Let's ask some of them, too, what some of their low priority projects are.
Thank you.
DR. BLACKWELL: Any comment?
MR. WOOD: This is, I guess, a response to the resource question. Again, I do not have the answer either, but in the opening session, the drug experience reporting costs have grown dramatically, and I think that the comments about drug sales and volumes come within that.
You may want to take a look at that whole area and what is begin gathered and how useful is that information and how might that whole arena be reconfigured to get the information and the data that is needed.
DR. BLACKWELL: Any other questions?
[No response.]
DR. BLACKWELL: May I have another commenter, please?
MR. MILLER: Thank you. I am Pete Miller, EQUI AID Products, Incorporated, part of the pharmaceutical industry.
I would like to switch back the discussion a little bit to the use of resources and just some comments.
I do believe that surveillance is an issue that has suffered severely, and that the approval process, especially chemistry and manufacturing controls, has been a barrier to approvals.
I would like to maybe give a little example of where we had a problem with a competitor making essentially the same product that we were trying to get approval on.
At the same time we were being asked questions that we felt were very, let's say, less likely to create a problem or minor, we informed the Food and Drug Administration that a competitor was making a product, obviously illegal and obviously essentially the same product that we were trying to get approval on.
Nothing was done there, even an inspection of the facility to determine whether that was done, at least none that we can find out.
We feel that that is a very serious problem, and that there is a huge barrier for us, lots of small, intricate questions to see whether we are good enough to manufacture a product appropriately, and yet, nothing done on the surveillance side at all. That put us in a very serious economic situation. So I would just like to comment that that would be something that is very serious to us and reflects what has been discussed earlier this morning.
MR. GEYER: Mike, I have a question.
DR. BLACKWELL: Yes, please.
MR. GEYER: The information that you felt that we requested more than we really needed, did you say that was in the manufacturing part of the application?
MR. MILLER: That is correct.
MR. GEYER: Thank you.
DR. BLACKWELL: Any other comments from the floor at this time? There will be opportunities this afternoon, after each panel has presented. So, if you want to wait until then, that will be okay as well.
Yes, Dr. Mitchell.
DR. MITCHELL: I would like to go back to Dr. Dodemaide's presentation from the floor there and ask for a clarification on what he had to say. That clarification could go to the docket. If you do not have the answer, you do not need to make it here today.
I want to draw your attention to Section 116 of FDAMA, the manufacturing changes for drugs, and our need to put out a proposed rule having to do with Section 116 and relate that to your comment.
I think I understood your comment to relate to the reporting of the DER to one site, one address, and the supplemental and other changes to the application being reported to another, different address, New Animal Drug Evaluation, but if you could tie those two points in with what Congress is requiring of us in Section 116, it would be helpful for the docket and our use.
Thanks.
DR. BLACKWELL: Thank you, Dr. Mitchell.
MR. GEYER: Excuse me. I have thought of a question for Richard Wood.
MR. WOOD: Oh, great. You work too hard.
MR. GEYER: I know.
[Laughter.]
MR. GEYER: You talked about the need to have consumers more involved in some of the processes and decisions in CVM. From a consumer organization's perspective, what are the best mechanisms for you to be involved with the Center?
MR. WOOD: I think that CVM and FDA have modeled some of those points of involvement, and they need to be continued and not forsaken.
I think that the steps that do have a public health impact may need to be "transparent," I guess is the word that has been used. They need to be published in the Federal Register that there will be meetings held, and the purpose of the meetings, for roundtable discussions.
Another place where the model has worked most recently was within the USDA in building the HAACP rule, where all the stakeholders were around the table and discussed and worked so that all the interests were presented and dealt with, and we continually heard the current thinking of the agency, and we were able to respond to that until an end product came that may or may not work, but we felt that all of the pieces were addressed.
I am not asking for any stakeholder to come in and have their way. I agree that any step that is taken, for example, the steps that we have proposed in terms of identifying thresholds, have to be based on sound science, but you have the science. Now what do you do with it, and what do you ask once that data is there? That step is a step that all parties, including consumers, need to be at the table to discuss in some fashion.
MR. GEYER: Thank you.
DR. BLACKWELL: Any other questions?
[No response.]
DR. BLACKWELL: We actually have about 10 minutes before we were due to break for lunch. I do have to wrap up this morning's session with some summary statements, but I see that there is another comment.
Yes.
DR. DODEMAIDE: Thanks again. This is Robert Dodemaide from Hoechst Roussel Vet.
I have another comment on efficiency of the approval process which is different from what I had commented on previously.
Biometrics. I believe that if a firm puts in the protocol, a model which is agreed upon when the protocol is reviewed, and the data analyzed in accordance with that model and the data have been QC'd, there is a QA statement and a monitor compliance statement, I really do not see why the Biometrics people at CVM need to go through every single data point to check it off against the raw data, reanalyze the data. To me, that takes up a hell of a lot of time in the review process. It is often the cause of reviews going over the allotted time in the process.
I think that if the biometrics teams saw that all those items were in place, which should ensure to them that the interpretation of the results gleaned in the trial are as they are stated to be, there should be no real need for the biometricians to crunch those numbers again. I think that happens far too often, and I think it is a very big cause of inefficiency in the review process.
DR. BLACKWELL: Thank you.
DR. DODEMAIDE: I can understand your legal problems with that, but I think if you have all those items in place that I mentioned, that should go a long way to alleviate the need to do a QC, a 100-percent QC which is often done, and recrunch the numbers.
DR. BLACKWELL: Thank you.
Dr. Beaulieu, is that clear?
DR. BEAULIEU: I hear you.
DR. BLACKWELL: I think this would be a good time for me to just provide feedback to you now, and these are just the major points that we have been able to capture in writing, remembering every word has been captured by this gentleman over here. So let's not get too concerned if I do not quite state everything as you understood it.
However, if there is a major point that you believe should be mentioned after I finish these seven points, then I invite you to mention it.
Number one, what we have heard from one or more individuals is that CVM needs to look to our mission for the priority-setting. We are acknowledging that we have multiple priorities that are competing, and it is the belief of some that the mission statement really gives us a lot of direction about where we can shift resources, not so much from where, but to where we can do that, and we will certainly look at that statement again for that kind of direction.
Secondly, important to maintain a strong surveillance and compliance program. This has come up a number of times. This is particularly true with respect to unapproved products.
We have had a number of comments that relate to this, whether it has to do with--I think our last commenter--as I understood it, resources that are directed at those who are trying to do the right thing, while we seem to be ignoring those out there who are not trying to do the right thing. There are unapproved products on the market, and that appears to you to be a bit of an imbalance.
I think the companies certainly are concerned about competing against these unapproved products. It is very difficult to invest all of those resources and then end up meeting that on the market.
Just in general, with respect to resistance and so forth, a lot more priority on the surveillance and compliance program.
Drug availability has been mentioned as being very important, that we implement it fully, and I think that advice is pretty straightforward.
User fees have come up. We have had actually both sides represented on this issue. I have heard mostly opposition to the user fees as a solution for obtaining these resources, but I have also heard that if there is going to be user fees that those be directed in such a way that we will be able to make more products available, and that it be for deficit-reduction purposes, I believe, as is the feedback.
No? Not for. Okay. Boy, you all did not let me get away with that one either, did you? Thank you.
The fifth point, that third-party inspection should be pursued as a way of getting the mission accomplished. However, there are concerns expressed here, especially with respect to adequate training of these individuals, so that they understand what they are doing when they show up, and that we may seek to try this in some limited fashion in order to pilot it and learn some things.
The next one has to do with clear communication regarding new policies and requirements. We have heard this one presented from a number of individuals and from different perspectives, but just the need to communicate more and to educate, but on the resource side of that, what I heard was that we should rely more on the veterinary profession, on the producer groups, and on the regulated industry to help share this kind of information. In other words, do not try to do it all ourselves, but there are aspects to communicating and educating that you as stakeholders can do while we then place our resources more on the mission-related work as expressed in that mission statement.
Finally, CVM should examine our processes with respect to duplication of effort. A number of specific examples were given, but maybe we could do better in that what happens at the field office, the district level, and what happens at the FDA headquarters may represent some duplication and, again, wasted resources.
Those are the items that we have captured as key points. Is there one that seems to be so major that it should be on this list? Again, we do have everything on tape.
Yes, Dr. Mitchell.
DR. MITCHELL: In trying to articulate one, I think it was covered perhaps in your point on communication, but I think I heard from Mr. Wood and from AVMA and the Swine Practitioners, in particular, an emphasis on increasing or creating a means of communication, more of a dialogue, perhaps, and from a couple of our speakers I think our there, too, that maybe we do not have in place at this moment.
Is that a sense of anyone else that there is a need for more dialogue? Perhaps this meeting is an example of that.
MR. WOOD: You heard the point, and I affirm that, that, in some way, that process not be an informal one, but that it be an informal one, so that the issues that have been raised today can be documented that they are, in fact, being responded to or at least dealt with and looked at by the agency itself.
DR. BLACKWELL: Is that okay, Dr. Mitchell?
DR. MITCHELL: Yes.
DR. BLACKWELL: We are right on schedule, folks, and that is either a good sign or a bad sign. I am not sure.
I hope you will enjoy your lunch. We are going to start promptly at 12:45. We will ask that the next panel just come in and be seated, and we will get started.
Thank you.
[Whereupon, at 11:45 a.m., a luncheon recess was taken, to reconvene at 12:48 p.m., this same day.]
A F T E R N O O N S E S S I O N
[12:48 p.m.]
Stakeholder Panel #2
DR. BLACKWELL: Could you please take your seats, so we can get started? Thank you.
I hope that everyone had an opportunity to grab a bite to eat and unwind a little bit from our morning session, and we certainly appreciate you returning for this afternoon, so that we might continue our dialogue.
Some may be present who were not here this morning, and we simply would like to recap our purpose for being here today, which is extremely important to us. It is to talk with you, our stakeholders, and hear from you your opinions about where priorities ought to be within the FDA/Center for Veterinary Medicine, and as we address shortage of resources, to do everything that we are mandated to do, how can we best either improve our resource profile or how can we best shift our focus so that we are, in fact, getting the work done that is most important.
We had a lot of good information given to us this morning from the first panel, and that panel represented the regulated industry as well as consumer interest and the veterinary profession by way of the AVMA.
We expect that this afternoon will go just as well in getting very, very helpful information. I will, however, again emphasize to everyone who will be presenting that in addition to sharing with us where we should be spending more money, more time and more resources, we really also need to hear from you how to best achieve this.
Again, with our inability to do all that we are mandated to do today, either we need to stop doing certain things, or if we are going to do everything, we are probably going to need to get there by getting help from others through some means or additional resources that may be financial as well as human and so forth.
At any rate, that is why we are here today, and without further delay, I would like to go ahead and introduce our second panel, or panels actually because we do have two.
Representing stakeholders for this particular session, we have Dr. Paul Sundberg who is director of Veterinary Issues with the National Pork Producers Council; Ms. Kim Goss, manager of Regulatory Affairs with the National Cattlemen's Beef Association; Mr. Joel Brandenberger, vice president, Legislative Affairs, National Turkey Federation; Mr. Paul Rodgers, director of the American Sheep Industry Association; and Ms. Betsy Sheenan, executive director of the National Aquaculture Association.
Our format will be the same. We are going to ask each presenter to spend no more than 10 minutes with their presentation.
Ms. Wanda White is back in position with the paddles. I asked her during lunch what would she be planning to do with the paddles if people did not sit down, and I promised her I would not reveal to you what that is going to be, but it is ugly.
[Laughter.]
DR. BLACKWELL: So please try to stay within those time frames. We do have a large amount of information to cover yet.
Once each presenter has completed his or her presentation, then we are going to ask the FDA panel, whom I will introduce now, to seek clarification. Again, for the debaters in the audience, we are going to ask you to be on recess today. We will not want to debate any of the issues. We realize there are a number of hot-button issues that we deal with, but, again, our attempt as an FDA panel will be to make sure we have understood the input, the feedback.
We will then ask them to not pull out any soap boxes and make a speech.
To my immediate left is Dr. Stephen Sundlof. We heard from him this morning, and we certainly welcome him back. His presence is very important for this kind of meeting. Sitting next to him is Dr. Bert Mitchell who was on the panel this morning.
Oh, by the way, Dr. Sundlof is my boss. He is the director of the Center. So I should say that, right?
Sitting next to Dr. Mitchell is Dr. Steve Vaughn. He is the acting deputy director for the Office of New Animal Drug Evaluation at CVM. Next to him is Dr. Woodrow Knight. He is director of our Division of Biometrics and Production Drugs, and then, of course, Dr. William Keller, who is director of CVM's Division of Surveillance.
Paul, it is all yours.
DR. SUNDBERG: Thank you, Mike.
As Dr. Blackwell said, I am Paul Sundberg, and I am the director of Veterinary Issues for the National Pork Producers Council.
Among my responsibilities are interacting with the CVM on a number of animal drug-related issues, and I certainly would like to offer my appreciation and thanks for the opportunity to comment to the agency on behalf of the Council to the questions that are brought forth by the implementation of the FDA Modernization Act.
The National Pork Producers Council represents the Nation's pork producers through 44 affiliated State associations. Our members account for the overwhelming majority of the Nation's commercial pork production, and our pork industry is the fourth largest agricultural sector in the country. It generates approximately $11 billion in annual farm-gates sales, while creating an estimated $66 billion in economic activity, and employing 764,000-plus people.
I am going to attempt to give you some pork producer insights and reactions to the questions that were brought forth specifically by the CVM.
First of all, though, I want to emphasize that as a production industry, our pork producers are proud of their long history of safe use of animal health products. Our pork quality assurance program has been successful in delivering the messages of responsible use and in facilitating the contact and discussion with the experts that can give the producer the best advice when it comes to their total production system, animal drug use as well as housing as well as the animal husbandry. The PQA program is one of our most important educational tools, and we actively work to make sure that all of the Nation's pork producers have gone through this program.
To comment specifically on the CVM questions, Question No. 1, as we read it, is focused on the consumer protection functions of the CVM. The mission statement implies that there is a direct relationship between consumer protection and the public health and the health of animals.
As pork producers, we believe that the best way to provide the consumer with a safe food product is to begin with a healthy animal. Pork producers need timely cost-effective availability of effective animal health products to do this. It is imperative that the agency is timely in its approval process in order to make available to producers the products they need to do their job and maintain animal health.
The Animal Drug Availability Act was supposed to enable the process to be completed as quickly as possible through better communication and better clarification of needs, and we urge the agency to refocus on the intent of the legislation and to use it to fulfill its mission statement.
Question 2 asks about charging fees for CVM functions. The CVM, as we see it, is a Government agency that in its own mission statement, again, admits that it is a consumer protection organization. We are all consumers, and as such, we all benefit from the agency's mission and all contribute to it through our country system of taxation and allocation of resources. Charging fees for the function of the CVM would not be acceptable when it would result in increased producer costs for those products.
Question 3 asks about the delegation of responsibilities to third parties. As with any business, including pork production, the efficient utilization of resources is important, and we heard about the focus of the CVM as a business.
This may take some innovation for the delegation of responsibilities, and we certainly understand that, but any proposals for delegation must be brought forth openly with the input and cooperation of all that would be affected. They should, though, keep focused again on the agency's responsibility as a governmental organization.
In many ways, Questions 4 and 5 are very similar for our pork production industry. These both involve the opportunity for non-regulatory approaches, education, technical assistance, and collaborative problem-solving, and simply, the answer to Questions 4 and 5 is yes.
As with the veterinary medical industry, we would urge CVM to tap into the resources of our industry and continue to build the partnerships.
Stated functions and the charge was to be as specific as possible. I wanted to talk about the stated functions that include from the Office of Management and Communications and its communication staff that outreach efforts to consumers, professionals in the industry in communicating the goals and priorities of the Center.
As I said earlier, NPPC has an extensive network of communication and educational contacts. Taking advantage of these networks could work to our mutual benefit and result in better communication and understanding. I think that is really the key, communication and understanding. It does not necessarily mean agreement, but it means communication and understanding of position.
From the Office of New Animal Drug Evaluation in determining the hazards to humans of animal drug residues in meat, milk, and eggs, I wanted to bring forth an example of the agency successfully involving our industry. The issue of safe tetracycline residues in pork affected our opportunities of international trade, and through the agency's initiatives into researching these concerns and through its work with the CODEX process, we are hopeful that a solution will be coming forth shortly.
We have been very involved in these discussions and have been thankful for the opportunity to provide that input. Again, that is an important example of communication and understanding.
Office of Surveillance and Compliance developing enforcement strategies involving animal drugs, feed additives, veterinary medical devices and other veterinary medical devices, effective strategies for compliance have to be clear and involve input from those that will be using the products.
Pork producers want to know what the rules are. If they know what the rules are, they can abide by the rules. The implementation of the veterinary feed directive is a successful example of the CVM building a consensus that led to an innovative solution to an industry need.
Implicit in Question No. 6 is the assumption that there must be set some allocation of time and resources among the named international activities. I am sorry to say that in a global marketplace, each of these is important, and prioritizing them would be very difficult, if impossible, and each must be addressed.
It is imperative that the agency recognizes the capabilities, expertise, and experience of other nations and other people, other commodities, to continue to develop the communication that will allow partnerships that benefit our producers and the consumers.
We all have much to learn, and when we can use scientifically acquired data that can supplement the processes, we should do so to our mutual advantage.
That is the end of my statement. Again, on behalf of the National Pork Producers Council, I want to thank the agency for the opportunity.
DR. BLACKWELL: Thank you, Paul.
Any questions from the FDA?
Dr. Mitchell?
DR. MITCHELL: I would just say, again, I think one of the comments from the morning, and that is that it really would be helpful for us to hear in addition to the emphasis you are putting on programs that you would like to see continued any information you care to share about those that you think should be lessened or where the resources should come from.
DR. SUNDBERG: I think, Bert, that is a very applicable request, and in response, I would say that part of this is the communication and understanding that we may be able to supply more input to you on priority. What we would like to do is emphasize what we need to have done, and we could certainly be part of the discussions in the things that could be done farther down on the list.
DR. BLACKWELL: Any other questions from FDA?
[No response.]
DR. BLACKWELL: Seeing none, then we will move on, then, to Ms. Goss.
MS. GOSS: Good afternoon. My name is Kim Goss, and I am the manager of Regulatory Affairs for the National Cattlemen's Beef Association, from our Center of Public Policy, here in Washington, D.C.
The National Cattlemen's Beef Association is a grass-roots organization representing 230,000 beef producers, including 45 State cattle associations and 27 national breed organizations.
We are advocates for policy that will improve producer profitability and viability so that family farmers and ranchers can stay in business and future generations can work and care for the land.
Cattle producers form the largest segment of the U.S. food and fiber industry, which contributes more than $153 billion to the national economy and employs from farm-to-table over $1.6 million people.
On behalf of the cattle producers I represent, I want to thank the Food and Drug Administration/Center for Veterinary Medicine this opportunity to comment on the agency's efforts to implement FDA's Modernization Act of 1997.
You have provided us with a wide range of questions to respond to, of which we feel a few select are of particular significance to us as beef producers. As such, I will limit my remarks to these.
The first question I would like to address is show can FDA work with its partners to ensure that producers, both domestic and foreign, produced and marketed by the regulated industry, are of high quality and provide necessary consumer protection, and also how can FDA best establish and sustain an effective, timely, and science-based post-marketing surveillance system for reporting, monitoring, evaluating, and correcting problems associated with wide use consumption of FDA-regulated products.
First and foremost, the FDA needs to maintain a focus on sound science-based decision-making. FDA cannot be influenced by the wide range of groups on either an anti-technology or anti-science ideology who seek to impact the approval of therapeutic agents and animal agriculture. It is imperative that the FDA maintain a strong focus on science in the use of sound risk benefit analysis as decisions are being made.
In doing so, the FDA needs to continue to recognize that animal producers stand ready to play a central role in ensuring the safe use of products approved by the FDA.
The second question I would like to comment on is what approach should FDA use to ensure an appropriate scientific infrastructure with continued access to scientific and technical expertise needed to meet its statutory obligations and strengthen its science-based decision-making process. This is a critical issue.
On the one hand, this relates to the recruitment and retention of competent FDA staff. It is imperative that FDA maintain the high level of integrity and expertise in its FDA/CVM staff, and we would like to commend the talented and capable staff at CVM who have been willing to work with us to achieve our objectives of animal and human health.
Another key facet of this question is the academic infrastructure and support base so critical to contributing intellectual capital to address the science needs of this agency. In this regard, we strongly encourage the agency to work closely with the USDA, Agriculture Research Service, and Cooperative State Research Education and Extension Service. We encourage the FDA to work closely with these other agencies to ensure that science needs of FDA are met and that the research agencies have continued access to the financial needs necessary to continue contributing sound science-based information to both animal agriculture and the FDA.
A third question I would like to comment on is which of these functions do you believe offers the greatest opportunities for CVM to place more emphasis on non-regulatory approaches, such as education, technical assistance, and collaborative problem-solvings to protect and promote public health.
With respect to this question, the FDA/CVM is well aware of our commitment to employ our resources in concert with those of FDA and others through our beef quality assurance program to address animal and public health concerns.
We recently reaffirmed this commitment by pledging our resources and BQA network to prevent the issue of antibiotic resistance from becoming a threat to either the continued efficacy of important antimicrobials to protect the health and well-being of livestock or public health.
The last question I would like to comment on is in the international arena. CVM is faced with similar questions on the allocation of resources. Currently, the Center's international resources are split between international standard-settings and providing technical support to U.S. trade agencies. Would you maintain the current mix of effort, or would you change it?
Oh, excuse me. I am missing page 5. Here we are. Well, the reason I do not have page 5 is we are not aware of any particular conflict with the current allocation of resources in this area. However, we do want to emphasize that this is an important area for several reasons.
It is imperative that efforts to harmonize veterinary drug registration efforts result in a strong focus on transparency and sound scientific foundations. We have concerns that some countries due lack the degree of transparency that we currently benefit from here in the United States, and they seem to be moving towards a more socioeconomic criteria in their approval process.
Neither of these trends are in the best interest of livestock producers, the regulated industry, or consumers in the long run.
I would like to thank you on behalf of the National Cattlemen's Beef Association for this opportunity to present our comments on a few key aspects of the FDA Modernization Act of 1997.
Thank you.
DR. BLACKWELL: Thank you, Kim.
I like that creativity, thinking on your feet. That is great.
Any comments or questions from the FDA, or needs for clarification?
[No response.]
DR. BLACKWELL: I guess you did a great job. I mean, these folks are stumped over here. All right, that is good.
Let's move on, then. Joel, if you would like to come forward?
MR. BRANDENBERGER: Good afternoon. My name is Joel Brandenberger, and I am the vice president for Legislative Affairs at the National Turkey Federation here in Washington.
The National Turkey Federation represents all segments of the U.S. turkey industry, including processors, breeders, growers, hatchery owners, and allied industry. We are the only national trade association that represents the turkey industry exclusively, and we very much appreciate the opportunity to be here at today's meeting.
NTF has had the opportunity to work very closely in recent years with CVM, both on issues parochial to our industry and as an active member of the Coalition for Animal Health.
Before we go any further, I think we really need to compliment CVM for its willingness to embrace new concepts and new approaches to fulfilling its mission, and I do not think that willingness was demonstrated anywhere better than the spirit with which CVM and FDA worked with the Coalition to reach consensus on the Animal Drug Availability Act of 1996.
We still believe that this Act, if properly implemented, has the potential to protect the public health and promote animal health by making the widest possible variety of safe, effective animal drugs available, and while we are going to air some concerns and express some here today, as I have said many times, when we air these concerns they do not diminish in any way NTF's admiration for the leadership that CVM and Dr. Sundlof showed during the passage of the ADAA.
In preparing these comments, we did draw on our experiences, both in the organization's individual work with FDA and our work through the coalition, but the comments at NTF's alone. We have chosen to focus exclusively on those questions that we think have the most direct bearing on CVM's statutory responsibility to approve safe, effective drugs for use by poultry and livestock producers.
The six mandates of the FDA Modernization Act and the questions provided for this meeting all are aimed at determining whether FDA and its centers are performing their missions in the most expedient manner possible.
The answer is a little problematic in CVM's case because its mission is both to protect the public health and to promote the health and well-being of animals by approving new animal drugs.
Agency officials have really a very delicate balancing act they have to do here. Dr. Sundlof came out to one of our summer meetings a couple of years ago and spent a long time talking about just that balancing act that they have to make, and no one would claim the challenge is easy, but I think if we are going to be honest in our assessment, we would have to say that they are not always 100-percent successful in maintaining that balance.
We in the turkey industry in the past have seen some examples, one significantly in recent years, in which the animals in our care frankly were forced to suffer through some pretty tremendous discomfort and disease situations when we really believed the agency could have taken some action to alleviate that with no risk to the public health.
Obviously, I am getting into a proprietary area here, and it prevents me from discussing some details and specifics of the situation, but it pointed out the need to us at least for CVM--and this goes, I think, to the first question that FDA had, the need for CVM to provide, we think, better and clearer information about the specifics of the approval process and how the agency will maintain that balancing act.
I think sometimes if you understand that thinking behind the decision-making, it helps it go down a little bit easier.
We do believe CVM must retain the flexibility to assess each application and disease individually, but we still think a better job needs to be done in developing and explaining to stakeholders the principles that will guide it in evaluating the needs of the animal versus the needs of the public at large.
NTF believes this meeting can play a very important role in striking that balance. Indeed, CVM's first question, the first CVM-specific question, is designed to assess which of its functions truly are essential to consumer protection and public health.
NTF does not believe CVM should abandon any of its current functions, per se, but we do believe the agency must change, at times radically, its view of some of those functions.
You all may have heard me say this before, but NTF would suggest the most obvious candidate for overhaul is the agency's view of its mandate to determine the effectiveness of animal drugs.
I want to be real clear here for those who have not heard me preach this before. We are discussing only efficacy. NTF has never advocated relaxing the stringent requirements for determining the human or animal safety of a drug, nor do we advocate abandoning the basic requirement that sponsors prove a level of efficacy to CVM.
Most of the ADAA was devoted to modernizing the efficacy review process, and while we do believe the agency has made some modest adjustments in its outlook, we still think there at times tends to be a paternalistic view of efficacy that is at odds with the reality of modern animal agriculture.
The ability of poultry and livestock producers and of veterinarians to determine a drug's efficacy is far more sophisticated today than it was 35 years ago. Yet, at times, there still seems to be a belief that pharmaceutical companies will try to sell us snake oil and that animal agriculture producers and veterinarians will buy anything the drug companies try to sell us.
Frankly, such a view is insulting to the integrity of the animal health industry and it is insulting to the intelligence of farmers, ranchers, and veterinarians.
The turkey industry is an integrated industry with experienced veterinarians who conduct their own rigorous efficacy tests before dispensing a medication to the flocks under their supervision, and despite a recent uptick in turkey prices and downturn in corn prices, we also are an industry that has lost money for 3 straight years.
We can barely afford to administer efficacious drugs, and we certainly cannot afford to use drugs that do not work.
Again, there have been instances recently in which drug companies have partnered with our industry on preliminary trials so that producers are convinced of a drug's effectiveness before the drug company seeks an approval from CVM. Even then, when the turkey industry has conveyed to CVM its believe in a potential drug's efficacy and the desperate need or that drug, the efficacy testing burden at times has been so great that the approval had to be abandoned.
NTF recognizes that the agency believes it has made significant strides in changing its view of efficacy approvals, and again, we acknowledge that there has been movement since the passage of ADAA. It would not be fair to say otherwise, but the anger and frustration we have felt at times, especially in the past year, tells us that more change still is needed in this area.
There are at least three other areas in FDA and CVM's questions on which NTF would like to comment. The first is the allocation of agency resources.
We would echo the comments that others have made earlier in today's presentation that CVM's primary responsibility is to approve animal drugs and to monitor the compliance in their distribution and use.
The agency should make all staffing decisions with this precept in mind. Now, we are not encouraging CVM to abandon any of its other functions, only to be ultrasensitive to the impact that staffing decisions have on the agency's ability to provide adequate resources to its primary mission.
A secondary area of questioning has to do with eliminating the backlogs and the review process. We think a revised outlook toward efficacy and appropriate staffing will help, but we also would urge CVM to make good use of the presubmission conferences with sponsors. The agency for sometime has been conducting these conferences on an informal basis, and anecdotal evidence indicates they have helped tremendously.
The ADAA enhanced this concept by creating a mechanism for formal binding presubmission conferences. NTF believes there are instances when the formal conferences could even further speed the approval process and reduce backlogs.
Yet, there have been few, if any, formal conferences in the 2 years ADAA has been law. We do not assess any blame for this. We think new ideas take some time to take root and develop. We strongly urge sponsors to seek these formal conferences where appropriate, and we, again, make the same recommendation to CVM.
I think more than just saying we are committed to the conference, we would urge CVM to look for opportunities to recommend them to sponsors where they are appropriate, to take the initiative in this area.
I think if we do not take advantage of them where they are appropriate, we do not think they will ever realize their full potential to help speed the process along.
One last thing I would mention in this area, and that is very briefly, is part of eliminating the backlog and moving the process forward is also going to be to have an effective minor use/minor species program in place. I think there has been a lot of good work done at the agency on trying to develop one. We have some concerns about it maybe being a little too heavily legislative in its proposal. We have talked about this in a number of venues, but we would encourage the work to continue and to look to maximize the number of opportunities where FDA can move things forward administratively, rather than rely on congressional action, which sometimes is a bit of an iffy proposition.
Finally, I want to just touch on user fees briefly. It seems to have been a theme that is running through the questions and through today's program.
Somebody spoke today and outlined some very specific conditions in which user fees might be acceptable. We do not have that kind of detailed policy. Our position is very simple. We do not think it is appropriate to discuss them until we are convinced that the ADAA is implemented in a manner that is consistent with the spirit of its passage, that everything is being done administratively that can be done to speed the approval process alone, and that increasing the staffing levels and providing the financial resources necessary to do that is the only way possible. Obviously, we do not think we have reached that point.
Thank you again for the opportunity to comment on this, and if we have dwelled a little bit on the negative, it is only because the purpose of today's meeting was to find improvement.
We know CVM is committed to change, and if we are frustrated at times the pace the change is taking, we are still appreciative of the commitment to move it forward.
Thank you all.
DR. BLACKWELL: Thank you, Joel.
Dr. Sundlof has a question.
DR. SUNDLOF: First of all, I have a statement, and that is that I had a turkey sandwich for lunch.
[Laughter.]
DR. SUNDLOF: Joel, you mentioned that we should reprioritize our resources to deal with those two functions of approval and compliance. There are a number of other areas, of course, that we are involved in, things like international harmonization and such.
Can you suggest certain areas that you would see that we have put less of a priority on?
MR. BRANDENBERGER: International harmonization would be one of them because that is part of the long-term picture. We recognize that.
Without spending a little more time studying the staffing structure and everything, I would hesitate to say to make a recommendation right here. We would certainly be happy to discuss that in a little more detail further. I have not given that a lot of thought.
I do not know that you have much room to downgrade things. I mean, I recognize the problem you are working on here, but I do think that in the area of prioritization, as you staff other areas and you have got to make decisions, every time you pull someone away from the approval process, that is going to have an impact. So we are really at this point just urging that that be part of the decision-making every time. It may well be already.
DR. SUNDLOF: Thank you.
DR. BLACKWELL: Other questions or clarification?
[No response.]
DR. BLACKWELL: Then with that, we will go to Paul Rodgers.
MR. RODGERS: Thank you, Dr. Blackwell. Thank you for inviting me.
I am Paul Rodgers with American Sheep Industry Association. I appreciate the opportunity to come here and offer some comments. I do appreciate the opportunity to work with the agency. It is always a pleasure.
We have had several opportunities and some very good dialogue, and we do appreciate it.
Our industry is rather small in a global context. There is 70,000 producers of sheep in the United States. We believe in maintaining and building a sustainable sheep industry that is both profitable economically and environmentally sound and committed to providing products of high quality, value, and safety.
We appreciate the efforts and mission of CVM, and it so happens we have the same mission and same goals, healthy animals and safety products.
We will be submitting formal comments. So I am not going to be too redundant. I guess some redundancy here with my fellow panel members is appropriate, but there will be several things addressing the questions that specifically were asked that we will put in our formal comments and we will submit.
I want to cover a few key points, and most of them are dealing with 4, 5, and 6. I do want to say that fully implementing the ADAA, I believe, will be an essential reprioritization that is consistent with the questions you ask and consistent with the CVM mission.
Our industry is somewhat handicapped because of the lack of therapeutics and other products to keep our animals healthy, and to optimize the productive potential of them.
This makes us less competitive in the global marketplace, and does impact us economically every day. We have worked diligently over the past few years on the ADAA, and we look to that to provide a remedy. It did not necessarily.
We are anxious to see the report. We commented on a discussion draft earlier this year. As Joel indicated, we were hoping to see some more regulatory approaches rather than legislative, and again, we are anxious to see what the report is going to say.
There were several issues brought out in that discussion draft in minor use/minor species that I think also address some of the questions that we are dealing with today.
Our comments on these issues are a part of the public record. So I will not go into them.
In a related matter, sheep are not totally classified as a minor species in all categories, and even though for over 6 years, CVM has promised that there would be a publication for public comment on this issue, we have not seen it, and we are looking forward to that as well.
I will conclude by emphasizing that we believe our industry and the public will be best served if the agency stands firm on science, including risk benefit analysis.
It is important not only in evaluating submissions, but in collaborative problem-solving and education. The process by which the veterinary feed directive, the BSE rule, were evolved and moved forward, I think, were good models of collaborative efforts. I think it showed that the agency is able to and anxious to respond to very important rising emerging issues when they come along and you are able to do a very good job of it.
We would encourage CVM to foster a close relationship with USDA, research and education agencies, to help ensure the agencies and stakeholders, science and technology transfer needs are more fully met. I think there is an opportunity there.
To echo again something that was said earlier, formal presubmission conferences, we believe, are an effective way of dealing with some of these problems and backlog.
In conclusion, our industry is always anxious to collaborate with CVM in all the ways possible, focussing on problem identification and problem solving, technology transfer. We have quality assurance programs, as do the other commodity organizations, and monitoring programs. Again, our goals are the same, healthy animals and high-quality, safe products.
DR. BLACKWELL: Thank you, Paul.
Any questions from the FDA?
Dr. Sundlof?
DR. SUNDLOF: Paul, this is in response to one of the issues you mentioned, and somebody else mentioned it, too--I think it was Kim--that urging us to develop cooperative relationships with both CSREES and ARS. Is there a perception that we do not have a good working relationship or that we do not work closely enough or that we are duplicating each other's efforts? Could you clarify that?
MR. RODGERS: I certainly do not think that there is a perception that you are not trying your best to do what you can in collaborating with these other agencies.
I think there are some other opportunities, and I believe that will also mean that they have to have a more open mind about that. There might need to be some reprioritizing in those agencies to address some of the issues that CVM is facing. There are many areas, I think, we traditionally looked at, but I think there are some other opportunities.
I know that this morning you addressed extramural research. I did not hear you address intramural research programs or funding, but I think that is an area that we could engage a broader audience between agencies and with some stakeholders on.
DR. BLACKWELL: Any other questions?
[No response.]
DR. BLACKWELL: Our final presenter on this panel will be Ms. Sheenan.
MS. SHEENAN: Whereas Kim was looking for page 5, I am just hoping that I can read my pages. My reading glasses, I grabbed the wrong ones, and as you get older, you have got to strengthen them. Mine are not that strong on this pair.
I am Betsy Sheenan. I am executive director of the National Aquaculture Association. We represent over 40 State and species-specific associations.
What I would like to do is just give you a little bit of our current situation, and then I think when I address our needs, it will answer the questions that were presented to us.
Commercial aquaculture, the rearing of aquatic animals and plans under various degrees of human regulated environmental control is the newest form of agriculture in the United States. According to USDA, we are the fastest-growing agribusiness in U.S. agriculture.
Commercial aquacultures raise fin fish and shellfish primarily for human consumption, but also for recreational fishing and for ornamental purposes. A diversity of species are raised in fresh and saltwater, using a diversity of methods.
With the significant trade deficit in seafood and an innovative aquaculture community, the prospects for U.S. aquaculture are bright. Yet, in spite of the apparent potential for continued growth and prosperity, U.S. aquaculture is significantly hampered by a dearth of drugs and water treatment chemicals. There are currently only two antibacterial drugs approved for aquaculture, and these two drugs are limited to only a few species of aquatic animals for a limited number of diseases.
There is basically one approved parasiticide, that being formalin. That is one approved anesthetic, and it has a 21-day withdrawal period that limits its usefulness for food fish.
The FDA has worked with our industry seeking ways to enhance the availability of needed compounds. They have examined some of the compounds, such as salt which enhances the osmose regulatory ability of fish, and determine that while they are not necessarily generally regarded as safe, they are a low regulatory priority.
This effort has provided a limited degree of improvement, but considerably more needs to be done. The recent FDA institution of a mandatory seafood HAACP program highlights the importance of only using approved drugs and chemicals in aquaculture.
Within the context of trade globalization, U.S. aquaculture is at a significant disadvantage. The availability of aquaculture drugs in many other countries far exceeds the few that are available for our industry. In some countries, as many as 16 different drugs can be used. Many of the fish produced in these countries are exported to the U.S., where they enter the human food market.
If seafood safety is a concern, it makes little sense to tightly control the availability of drugs for aquatic animals produced in the U.S., yet readily admit such treated animals into the U.S. market from foreign countries. Aside from food safety, there is an unfair production advantage for our foreign competitors.
Drugs, while not a panacea, can be useful to treat aquatic animal diseases and also as spawning aids. We do not use drugs for growth enhancement. Delivery of drugs to the aquatic animals is problematic. Rarely can individual animals be treated. Fin fish and shellfish are raised together in high numbers within a pond, raceway, or net pan. Health management must focus on veterinary herd health concepts and epidemiology of disease. Extra label use of drugs for aquatic animals is impractical since antibacterial drugs must usually be delivered via the food. Food is specifically prohibited as a delivery mechanism of extra label drugs in the U.S.
The FDA/Center for Veterinary Medicine has been working with our industry seeking ways to encourage additional drug availability. Public aquaculture, the U.S. Fish and Wildlife Service in various States has also provided considerable leadership and funding over the years.
We greatly appreciate these efforts. Unfortunately, progress has been very slow. More needs to be done by the CVM, the pharmaceutical industry, and the aquaculture industry.
There are specific items we suggest CVM could devote increased emphasis on. Early this year, a number of minor animal species groups, including the National Aquaculture Association, provided comment on a discussion draft, proposals to increase the availability of approved animal drugs for minor species and minor use, more commonly known as the MUMS document.
This was prepared by CVM so that it could help foster increased drug availability. We maintain this proposal made some significant advances in how FDA might readily approve the availability of drugs to minor animal species.
If you hear nothing else that I say today, the one thing that I wish you would take home is that the industry would like to see the MUMS document passed onto Congress as it originally came out of CVM. Supposedly, it was going to go last April, I think, and we would like to see it go tomorrow.
The NAA is also a member of the Minor Species Animal Health Coalition whose mission is to develop and help implement transitional and long-term solutions, again, that allow the safe use of animal drugs and feed for minor species in a manner acceptable to both the industry and to CVM.
This Coalition proposed several mechanism for drug availability enhancement, including an expanded use of the veterinary fee directive. We believe CVM should reexamine this issue and visit further with the Coalition.
U.S. aquaculture must have additional drugs available to treat fish and shellfish diseases. The very limited number of compounds available for use significantly compromises our ability to intensively rear aquatic animals. There is a need for label extension of the currently available, any microbials to include other fish species and other diseases.
There is a great need for new antibacterial compounds to treat all fish species. With only two antibacterial drugs available, we are quite concerned about the development of antibacterial antibiotic resistance.
There is a great need to increase the number of parasiticides available for aquaculture use. Copper-based compounds, such as copper sulfate, are potentially valuable, but they may have a limited broad use because of the environmental impact concerns.
The EPA has very strict metal toxicity criteria that may limit the utility of copper sulfate in aquaculture situations. We need alternative compounds.
We need treatments for a variety of external bacterial and fungal infections. There is a particular need for bacterial gill disease treatment.
The NAA is in strong support of allowing extra label use of medicated feeds for minor animal species and uses. We suggest an expanded veterinary feed directive program which could assist in this area.
There is considerable need for CVM to promote international drug use harmonization. CVM needs to determine whether foreign countries' requirements in system for animal drug approvals are equivalent to those in the U.S. We believe seafood requires all aquacultures to use drugs judiciously, in accordance with Federal law.
CVM should develop an appropriate monitoring mechanism to ensure violative residues do not occur in product imported in the U.S. We appreciate CVM's active efforts to date to develop international harmonization programs.
We appreciate very much the opportunity to participate in this panel. It is rare that we have had the opportunity to partner with FDA in examining CVM priorities. In recent months, we have had more and more dialogue with CVM, two projects which the aquaculture industry is very interested in, one being a new ad hoc committee that we have formed, the Aquaculture Partnership.
We believe that progress can continue to be made to increase the availability of drugs. Again, we encourage that the MUMS document go onto Congress as it came out of CVM, and we are ready to assist in any way that we can help with any of these efforts.
I have been on travel, and we prepared our comments and then the questions did come in, but just very quickly, if I have got one minute, in response to the partnerships and stakeholders working together, two things that we would like to see. One is that CVM work closer with the sponsors to ensure submissions in the proper format and possibly develop a sample submission as a guide for the sponsors.
The second thing is on communication. We would like to see that all product information be available on the web site, and we would like to see CVM target some key industry persons who can provide alerts on new products that are in the pipeline to the Federal Register and have already been approved by FDA.
I think I have covered it. Thank you.
DR. BLACKWELL: Thank you very much.
FDA?
[No response.]
Questions and Comments from the Audience and
Summation of Major Points from Panel Discussion
DR. BLACKWELL: This means we can move into more general feedback from the audience.
I did have a question, though, before we do so. I was wondering if any of our stakeholder panelists are lawyers. Any lawyers?
[No response.]
DR. BLACKWELL: Just an observation. I noticed we were running a little bit ahead of schedule, compared to this morning, and I could not miss the opportunity to try to figure this one out and noticed that Dick Geyer and Jess Stribling were in the back of the room. There seems to be an association with the lack of lawyers with this panel, I think, and our ability to move quickly through our agenda.
I am happy they are still here, though, because lawyers keep us really entertained.
[Laughter.]
DR. BLACKWELL: At this point, we really do want to invite anyone from the audience who might have feedback for us, to take this opportunity.
There is a mike in the center aisle, and I see John Adams is on his way up. We will seek your input. Thank you.
MR. ADAMS: Thank you, Dr. Blackwell, members of the panel, and my colleagues up here on the other side.
National Milk will be submitting comments to you later. I just wanted to make a few observations.
First of all, there has been a lot of emphasis on priorities today, and it is quite obvious from your comments, Steve, earlier that your agency, like a lot of other agencies in town, is facing severe budget constraints. I think that is obvious to everybody here.
If you are looking at the overall picture of how you set priorities under these difficult situations, my observation is that while many of us in the industry want to see new products on the market, and I would be one of the first to admit that in talking with our veterinarians out in the country, they are quite anxious to have new products approved for treating lactating dairy animals.
As an industry representative here, I have to point out to everyone the serious consequences of some of the enforcement problems that we face, and the BSE situation, I think, takes highest priority.
I want to call your attention to an Atlantic monthly article that appears in the September issue. This is a very complete review of the BSE situation that we all faced, and the author is very objective in many cases, in other cases maybe not so objective, but she criticizes a number of agencies, and CVM is also criticized in this article.
I am pointing this out because I think you need to address this as an agency. I think you need to respond to this article, and I will leave it so that a copy can be made, but I think it also points out the dire need for priorities to be set on the enforcement side because this author is suggesting that FDA does not have the resources or is not looking hard enough at the rendering industry and the possibility of the transmission of TSE into the food supply through the rendering process.
We ourselves have brought to your attention, as you are aware, from time to time, the issue of animals that have exhibited neurological disorders and how we are going to deal with those types of animals at slaughter. As an industry, we have requested FDA and USDA to work together to make sure that there is a fool-proof system in effect and enforced to make sure that those animals do not reach the food supply if, in fact, they are not approved for food use by an accredited veterinarian.
So I bring these issues to your attention because obviously, as a food supply industry, we are very interested in protecting the public health, and when budget becomes the issue, then the highest priorities of the agency have to go to protecting the public health.
I was asked to participate recently in a meeting that CVM was sponsoring with regard to the enforcement of the BSE rules, and I want to compliment publicly the agency for your efforts with regard to developing the BSE rule. I think we all realize it was a very difficult and complex set of issues. So the agency from our standpoint should be commended for your efforts, but now there is the enforcement issue.
All that good work that was done now is on the line unless it is properly enforced, and when I was told the other day that a major portion of that program had to be delayed because of lack of resources, I was reminded of priorities.
So, while I am here to say that we as an industry need new drugs, we also have to think about what would happen if we had a calamitous outbreak of such a disease as BSE or TSE. I think we would all realize under those circumstances that enforcement and priorities on the enforcement side would be extremely important.
DR. BLACKWELL: Thank you.
Any questions from FDA for clarification?
Dr. Sundlof has one.
DR. SUNDLOF: I would just like to clarify our priorities on BSE enforcement. What we have done and agreed to do is inspect 100 percent of the establishments that in any way handle these prohibited materials. So that includes all of the renderers, all of the feed mills, distributors, protein blenders, et cetera, over a 2-year period.
To do that, we are allotted a certain number of field resources to conduct our inspections, and that includes such things as follow up on residue violations, inspecting plants for good manufacturing practice, compliance, and a number of other things.
What we have done in conjunction with our field resources is that we have said we are going to focus a large majority, more than 50 percent of our field resources, on the BSE enforcement issue, which means that those other programs, such as follow-up on violative drug residues in animals are going to have to slide for the next couple of years because we agree with you, John, that failure to enforce this rule can lead to the same kind of disaster that occurred over in the U.K. We certainly do not want that to happen, and so your point is well taken.
DR. BLACKWELL: Thank you.
Any other commenters?
[No response.]
DR. BLACKWELL: Do we have our list already?
What I will do is go ahead and run down our list, as these are the major points as we have captured them. Again, we are making a transcript of this proceeding. So all the details will be captured, but what we have heard during this panel, there are five points that we are going to summarize.
One, that drug availability is critical, that the ADAA should be fully implemented, and specifically as it relates to minor uses, minor species, and the veterinary feed directives.
Secondly, risk assessment should be used to assist in making science-based decisions.
Thirdly, CVM should foster a more cooperative relationship with USDA's Agricultural Research Service and CSREES, Extension Service, to obtain needed scientific expertise.
I interpret this one, as I heard the feedback--and a couple of people did make this point, but I guess I understand this feedback to mean that we should be looking to the other Department, USDA, in collaborating with them and joining resources in some of these areas in order to help meet our mission, as well as theirs. If that is not the essence of that, please correct me.
[No response.]
DR. BLACKWELL: Okay, thank you.
But no one said single food agency, right?
[Laughter.]
DR. BLACKWELL: Good. There is a subtle different there, and we want to make sure we caught that.
Fourthly, clear communication is critical. CVM should take advantage of established networks of producer groups, as well, I guess, as the other professional groups that are presented here today in order to get our message out.
We heard a little bit about this, this morning. It is really very nice to hear many of you come forward and talk about hoping to do the kind of work that we so much need to do as far as communicating our decisions and the needs, and I think we have very excellent examples, as we have collaborated in recent years, but what I understand you to say is you are willing and able to do a bit more, and we should look to you in order to provide some relief and at the same time achieve the important objective of communicating better with everyone.
The last major item captured is that it is important to work with international groups. When I looked at the word "international," first I saw "institutions." Anyway, international groups to ensure harmonization.
A lot of collaborating is needed. We all keep saying that, hearing that. I think most of us here present today realize that a lot of work is going on, but what you are saying is that we need to really keep some priority there because it will, again, be another way to provide relief. That may be in the context of accepting information from other countries as it relates to the drug approval process, but certainly, when we look at trade issues and certain barriers that may exist because of differences, again, there needs to be priority placed there as well.
Now I am going to get myself into trouble again, as I did this morning, and say that we are hearing a lot of spend more here, spend more there, spend more there, a lot of good feedback actually. I want to make sure that we have not missed any specific advice with respect to where we no longer need to spend.
I did hear about the efficacy part. You were real clear about that part.
MR. BRANDENBERGER: Do you want me to go over it again?
DR. BLACKWELL: No, no, no. We heard that one.
But outside of that area, is there any other area that did not seem to be captured? I am saying this for discussion purposes right now where we might shift resources or priorities, in other words, stop doing certain things, or is it all about really needing to try to get more resources to do everything.
Could you all comment on that?
[No response.]
DR. BLACKWELL: We like knowing and believing that all we are asked to do is important, and that we should be seeking to do it, but it begs the question how to do all if we do not have the resources to do all.
MR. BRANDENBERGER: I will jump in a little bit.
DR. BLACKWELL: Could you please use the mike?
MR. BRANDENBERGER: Sure.
DR. BLACKWELL: Only if you are not going to talk about efficacy.
MR. BRANDENBERGER: Returning to page 3--no. I will jump in just a little bit here.
I think there is probably a natural reluctance on everybody's part to come up here and say quit doing this and quit doing that, and frankly, at least just speaking personally in preparing for this, there was not a time, and I do not think I wanted to be presumptuous enough to say stop here, but one thing that might be worth looking into as a follow-up to this meeting may be getting the stakeholders back together with that specific mission. That was one of 10 or 12 things thrown in here today, and everybody is trying to jumble all of them. We do not have to do it all day, but maybe a little less formal, get the stakeholders back together and focus on just that question, what can fall off the table if we have got to do more here. I think you might get some very specific targeted answers in a session like that.
DR. BLACKWELL: I am sure that we are going to continue to talk. As all of you have commented, there has been a lot of communication and collaboration and coalition-building going on in recent years. We certainly do not plan to stop doing that.
We will invite you to continue to think about that question because that is, in fact, what we are faced with right now, how to continue to do all that we are asked to do or get rid of some things.
Interestingly, in this country, and maybe we should say in the whole world, I do not think there is any part of the FDA mission that does not have a supporter, and that makes it very interesting when we start down that track.
Audience, we have some options here. We are running about 30 minutes ahead of our schedule. I think we were scheduled for a break at 2:30.
I did not bring any shoes to tap dance today. So we are going to have to figure out what we do at this point. I think some may be scheduled to show up a little bit later. I am not sure if all the panelists are here for the third panel, but that being the case, do we have any suggestions?
Finish early? Okay. I do not hear any objections to that.
We are going to go ahead and take our 15-minute break and then get started in 15 minutes with the third and final panel.
Thank you.
[Recess.]
Stakeholder Panel #3
DR. BLACKWELL: I would like everyone to please take their seats so we can begin our last session.
Welcome back to our third and final session today, and we again are going to stay with our format. It seems to be working at least to our satisfaction.
At the end of this panel discussion, we are going to again open it up for any comments from the audience, and we will then have a final summation which basically will be all points that we have heard today. I think that will probably bring us to the close of this session.
So far, I have been hearing very positive comments about how things are going. We really are happy to hear that because it is really your meeting and your opportunity to talk to us about issues that we think are very, very important.
I do want to clarify one point that was made. Joel Brandenberger had talked about the priority placed on efficacy, and I teased him a little about that. There have really been a lot of hot debates on the subject, actually, as all of us know, but one clarification that I think is important to share with the group is what we have been hearing from a number of people today repeatedly with respect to priorities is that when we look at the CVM mission statement, it talks about safety. It talks about product quality, and then it talks about efficacy.
The understanding of some is that that provides direction to the Center with respect to priorities, and so I believe if I could extrapolate from that, then, the efficacy piece, although important, that importance stands relative to first safety and then product quality. Whether we are talking about preapproval work or postapproval surveillance and compliance, enforcement-type work, human safety, public health safety from the standpoint of potential injury to human health as it relates to the safety of the product and the quality of the product should be our primary focus.
Now, did I get that right? Okay, good. Safety first, product quality second, and then efficacy issues. Good.
That is the kind of thing we want to be able to walk away with is clarity on your points, and I really, really did appreciate having it all cleared up for me.
With that, let's move to our last discussion here, and I want to introduce to you our third panel of stakeholders. Starting to my immediate right is Mr. Dave Bossman. He is president of the American Feed Industry Association. Next to him is Mr. Randall C. Gordon. He is vice president of Communications and Government Relations with the National Grain and Feed Association. Next to him is Dr. Alan Hanks, president-elect of the Association of American Feed Control Officials. Next to Dr. hanks, we have Dr. Robert Zimbelman. He is executive vice president for Scientific Liaison, Federation of Animal Science Societies. At the end of the table there is Dr. James Jarrett, executive vice president of the American Association of Bovine Practitioners.
On the FDA side here, we still have Dr. Sundlof. Mr. Geyer has rejoined us here at the front, and the new people here would be Dr. George Graber, who is director of the CVM Division of Animal Feeds, Mr. Michael Rogers, director of the FDA Kansas City District Office, which by the way is our primary district office, given the location of most of the industry for animal drugs, animal pharmaceutical agents, and then, of course, Ms. Gloria Dunnavan who is director of the CVM Division of Compliance.
We want to welcome all of you. We, again, are looking forward to the feedback that you have for us, and our FDA folks are here to make sure that we do understand and will probably want to ask some clarifying questions after each presentation.
Mr. Bossman, if you will just come forward, we will get started with you.
MR. BOSSMAN: Good afternoon, Dr. Blackwell, Dr. Sundlof, the rest of the panelists, ladies and gentlemen. Thank you for the opportunity to be a part of this dialogue and on the future of CVM. I am pleased that we are able to join the other stakeholders in going this.
Overall, we urge the agency to carefully review its charter and its mission and statement in determining the program and spending priorities. We have explained to CVM in prior years, it is politically difficult, if not impossible, to find support for a greater CVM spending if the agency cannot demonstrate it is gaining maximum benefit from the money it already had.
AFIA will file detailed answers to the specific questions posed in the meeting materials, but in the allotted time, let me explain some of our chief areas of concern.
One that I know is a great deal of concern and of interest to everyone is Question No. 2 as it relates to user fees. AFIA is categorically opposed to federally regulated industry paying for the privilege of Government-imposed consumer protection programs.
I guess we cannot say that any stronger or any louder. The arguments that labeled approvals and ingredient approvals, plant and facility inspections, et cetera, that provide primary benefit to a regulated company is wrong. User fees are simply a de facto tax on a regulated industry.
We are willing to examine the possibility that certain CVM services may provide, greater corporate than public benefit, such as GRAS notification and formal opinion requests, et cetera.
We would actively participate in any effort the agency may establish to identify such services for which a fee may be contemplated. Our willingness to do that, however, should not be taken as a weakening of our longstanding opposition to user fees, as a budgetary gimmick or a replacement for responsible budgeted administration.
Field offices. We have long been frustrated by the lack of uniformity in the enforcement area among field offices, especially when it comes to GMP inspections of feed plants. Over time, we have made CVM abundantly aware of that frustration and continue to be frustrated with the following problems of CVM field personnel, inspectors demanding computer validation documents, inspectors who admit they have never been in a feed mill, inspectors citing violations for food and not feed in GMPs, and district offices setting compliance standards which are generally at odds with CVM in Rockville.
We recommend enhanced training and education for the inspectors and reviewers, and as willing to examine the possibility of a joint industry-agency training effort, we also urge enhanced directed monitoring and oversight of field offices by the Washington administration.
We strongly recommend the Office of Regulatory Affairs ensure full funding for any State programs under contract with GMP inspections.
As it relates to the fourth question of the voluntary self-inspection program, it would be a good example. The Joint AAFCO/FDA voluntary self-inspection program offers the agency the opportunity to reduce the resource-intensive GMP inspection process while maintaining and possibly even enhancing better than adequate regulatory control of medicated feed manufacturing facilities.
It is also an excellent example of how third-party expertise can enhance the agency's service, and we certainly think that VSIP is in the spirit of the VFD and the practical industry/government cooperation.
ADAA implementation must be fully implemented. We continue to be disappointed and frustrated by the lack of CVM progress in the rulemaking subsequent to the enactment of ADAA. We are especially interested when CVM intends to propose the VFD regs, as well as the final regs on feed mill licensing.
We understand such issues as the risk assessment. BSE demanded an inordinate amount of agency personnel time. However, it is imperative that internal roadblocks to ADAA implementation, including potentially expanding levels of review and regulation, be eliminated, so that the reality of the regulatory leaf can match the previous positive spirit of ADAA negotiation and legislative effort.
Frequently, I am reminded of the times when we were working on that. We are told that it was slow because the lawyers were working on reinventing the government, which we thought was what we were trying to do on the face of it instead of on the back side.
As part of GRAS notification, we urge CVM to emulate its sister agency, CFSAN, in using the proposed GRAS notification system to sanction more feed products and ingredients. They have demonstrated the system can be a practical tool for product reviews.
On the international, Question No. 6, we certainly are involved more with international activities than we ever have and understand and are sympathetic to the increased international demands on CVM time and budget. In this area, and this area only, AFIA may be willing to examine an early focussed support for increased CVM appropriation.
We offer to chair an industry/CVM exploratory task force on the feasibility of targeted appropriations for CVM international program efforts, including CODEX's drug residue standards, international harmonization, and all the technical trade issues to U.S. trade agencies.
I thank you for the opportunity to contribute to this dialogue, and as mentioned earlier, we will be providing detailed written comments to the specific questions.
Thank you.
DR. BLACKWELL: Thank you very much.
Any questions from FDA?
Yes.
MS. DUNNAVAN: Could you just clarify for me a little bit? When you were talking about the lack of uniformity in the field inspections, is that a rare occurrence?
MR. BOSSMAN: No. It is a frequent occurrence. There is a great deal of difference between the inspectors, and most of that is probably between one region and the other, and if you want some written specifics on that, we can give you a pretty long and detailed list.
MS. DUNNAVAN: Or maybe a little phone call. We could talk about it.
MR. BOSSMAN: Okay.
MS. DUNNAVAN: Thanks.
DR. BLACKWELL: Thank you.
Any other questions?
I did have one. I think you gave part of the answer to it. You mentioned implementing fully ADAA that we need to remove some internal roadblocks, as an example, additional layers of review. Could you help me understand? I did not quite understand what the fix is. What is it that you are getting at?
MR. BOSSMAN: I think there is probably too often, maybe between the people that are writing this and the lawyers that need to--
DR. BLACKWELL: I see.
MR. BOSSMAN: I am talking about the internal struggles that we understand may be happening from time to time within--
DR. BLACKWELL: Within FDA?
MR. BOSSMAN: Within FDA.
DR. BLACKWELL: Not just CVN, then.
MR. BOSSMAN: Yes.
DR. BLACKWELL: This extends beyond, okay.
MR. BOSSMAN: Clearly.
DR. BLACKWELL: Yes, I understand now.
MR. BOSSMAN: Getting it out of the agency.
DR. BLACKWELL: Right.
MR. BOSSMAN: And down the chain.
DR. BLACKWELL: All the signature blocks that are needed to get it documented or a decision out of the Center.
MR. BOSSMAN: Yes.
DR. BLACKWELL: Okay.
Any other questions or points for clarification?
[No response.]
DR. BLACKWELL: All right. Then we will ask Mr. Gordon to come forward.
MR. GORDON: Thanks, Dr. Blackwell.
We, too, at National Grain and Feed Association greatly appreciate this opportunity to present some recommendations on priorities we believe should be considered by CVM as it targets its future efforts.
Our association consists of more than a thousand grain, feed, and processing companies. About 70 percent of our membership are country elevators and feed mills.
At the outset, I want to express the NGFA's admiration and respect for the dedicated public servants who work at CVM, and commend the agency for the integrity and the fairness with which it seeks to execute its regulatory responsibility with limited resources.
I think today, if nothing else, CVM has a renewed appreciation for the appreciation that stakeholders have for the job it tries to do.
Indeed, we believe that the professional working relationship that exists between CVM and most of the regulated industry, a relationship based on a non-adversarial partnership whose foundation is mutual trust and respect, provides major new opportunities for enhancing food and feed safety while allowing the agency to more effectively allocate its resources.
We think that a prime example that merits high-priority attention from FDA is implementation of the voluntary self-inspection program for medicated feed establishments, currently being finalized by the Association of American Feed-Controlled officials as part of its national model, medicated feed program.
Under this concept, medicated feed establishments that have implemented written quality assurance programs that meet or exceed FDA's CGMPs, be they commercial feed mills, on-farm mixer/feeders, or integrators, would be eligible for this program and would be exempt by any FDA inspections, except for cause.
Yet, this program still would provide for prudent Government oversight. For example, establishments would be subject to preapproval inspections if they have not had a full-blown CGMP inspection during the previous 2 years. They would be required to submit an annual inspection report documenting that they had conducted a self-inspection, and they would still be subject to random spotcheck audits by Federal and State inspectors to verify their compliance with the CGMPs.
The voluntary self-inspection program also provides an opportunity for FDA to use one or more disinterested third parties as certifying organizations to provide education and training for inspectors.
Those certifying organizations also would be subject to FDA review and oversight. In essence, we believe this voluntary self-inspection program approach represents good government. It would promote industry self-regulation, and encourage the further adoption of quality assurance programs by all types and sizes of medicated feed establishments.
It would provide regulatory and marketplace incentives for companies to do so. It would provide for prudent, rational Government oversight, while freeing up scarce resources.
We have heard today about the importance of surveillance and compliance activities being targeted at unapproved drugs or misleading claims that truly can endanger consumers. Most importantly, we believe this program would contribute to an even safer and more wholesome food supply.
The NGFA also believes that FDA/CVM should continue its emphasis on providing education, information, and compliance assistance to the regulated industry. We commend the agency for allocating additional resources to its Office of Communications, and we believe the agency satellite teleconference for the feed industry on the final rule on the mammalian protein ban, as well as the small entity compliance guide publications that have been made available by FDA, represent kind of a case study on how we can work together in this sort of effort.
Using FDA's web site to convey this and other compliance information also is valuable to companies that have Internet capability, but the NGFA believes more can be done in partnership with industry organizations and FDA to produce brief, concise, and consumable information that will be useful to smaller establishments.
Trade associations such as ours and other stakeholders in this room can be a valuable asset to FDA in preparing, producing, and distributing this kind of information.
It is our sense that we have only begun to tap this potential. We pledge to work with the agency to identify other opportunities for mutually beneficial education and information efforts that contribute to food and feed safety.
Next, the NGFA believes FDA/CVM should seek ways to expedite its review and action on citizen petitions filed by interested parties seeking changes in the agency's rules or procedures.
Specifically, we urge the agency to reach closure on citizen petitions that have been on the docket for some time concerning animal drug assays and liquid feeds, as well as on the recently filed citizen petition urging the agency to proceed with rulemaking changes to its current good manufacturing practices that was filed jointly by AAFCO, AFI, and NGFA.
The citizen petition can be a valuable tool, both for FDA and for stakeholders. It is a way to bring the agency's attention--to the agency's attention, and to seek its determination on issues that stakeholders believe warrant serious consideration in a timely manner. We believe the agency should act on them in that light.
Finally, we believe the agency needs to place more emphasis on international issues, and as has been mentioned, in looking at the regulation of imported products into the United States and work on CODEX and some of the other efforts in international, we do not feel you can really choose between those two anymore. The global marketplace, as Joel said before, is really where it is today.
We do think more emphasis needs to be placed on inspections of imports for safety and purity, but with the important caveat that such inspection should not constitute non-tariff trade barriers. If they do, that will come back to haunt us.
We believe that to ensure U.S. interests are protected, the agency needs to place more emphasis on ongoing international negotiations on harmonizing international food and feed safety standards, including the development by CODEX of a code of good animal feeding practices that could come back to affect our own CGMPs in this country.
The NGFA also believes that FDA needs to be a supportive resource for other lead agencies, like the U.S. Department of Agriculture's Foreign Ag Service, in combatting non-tariff trade barriers, such as the European Union's proposals to require EU certification of both national feed and feeding regulatory programs in private production facilities in this country that export products to the EU.
Again, we would recommend that FDA not necessarily be the lead agency in these efforts, but that you partner with USTR and USDA and provide support as you can.
We appreciate this opportunity to provide these views, and, again, we will be amplifying on these in our written comments as well.
Thanks.
DR. BLACKWELL: Thank you.
Any questions?
Dr. Graber?
DR. GRABER: It is probably a question for both Randy and Dave.
You talked a lot about education activities, communications, training workshops and stuff. What are your views about a level of effort in the enforcement area in terms of regulatory actions? What level of commitment should there be in terms of enforcement, that is, regulatory activity?
MR. BOSSMAN: In which area?
DR. GRABER: In the medicated feed area, or feeds in general.
MR. BOSSMAN: Essentially, you have got a statutory mandate which we understand. I am not real sure that that is being used as well. We still run into the problem where one feed mill has an inspection three times in this span of time or where someone has never seen one. I am not sure it is equitably shared.
I think some of the issues that Randy talked about--well, the one, for instance, with the petition, the citizens petition that we just put in, it would make the playing field a bit leveler. I think that would go a long ways to smooth out some of the regulatory compliance.
All of the records that we have seen that you have provided us indicate that the feed mills are not causing a food safety problem. So I think your level of inspection probably is higher there, and their resources are probably spent there more than they should be if you look at it from a food safety perspective, but given your mandate, I am not sure what either one of us can do about that.
MR. GORDON: George, I might just add to that a little bit. I think the voluntary self-inspection program really gives a chance for the agency, as well as State inspectors, to rationalize their inspection a little more than perhaps has been done in the past, where you have industry doing self-inspections with the kind of Government oversight that is prudent.
It would allow you to target some areas perhaps. The larger commercial mills and many of the others have seen your inspectors many times, but many others have not.
I think it is important to have a credible compliance aspect to your programs. That and proper education and information facilitates compliance by the entire industry. You cannot not have an umpire out there and still have a credible program.
I do not want to speak for Dave, but I think from the industry standpoint, we are looking for a balance here. While more of the regulation and the inspections have been done on the medicated feed mills, the commercial establishments at this point, perhaps this would allow you to either save resources, if they are not needed for food safety reasons, and that is the bottom line, or target those in a little better fashion toward those that may not have seen inspectors in many years.
MR. BOSSMAN: Keep in mind, with all your inspections, that food safety is the issue. I think we have lost sight of the fact that we are not having to protect the small producer from the big bad feed company anymore. Food safety is an issue, and that is the only real issue of concern as it relates to your inspection procedure.
Also, there is a huge difference between whether it is an FDA inspector and whether it is a State inspector. That should be leveled out as well, and I know there are some States that have gaps simply because of the contract or no contract with the agency.
DR. BLACKWELL: Yes, Dr. Sundlof.
DR. SUNDLOF: Randy, I just wanted to follow up on one of the points you brought up about the code of good practice in animal feed. Does National Feed and Grain Association have a position on that, whether you want that, whether you think having an international code is a good idea, a bad idea? You have obviously seen the draft code. What is your position on that?
MR. GORDON: Well, I think we are not necessarily opposed to it, so long as it models to the greatest degree possible the current GMPs that FDA has, and the current draft, I think, moves in that direction, but what we are leery of is having that steered in another direction at some point.
I think it is something we really appreciate the agency's leadership on in helping to craft that document, and I think it is going to be real important to manage it all the way through at this point.
DR. BLACKWELL: You probably answered this question already, but let me make sure. I do not know if I heard it, and I wanted to get your perspective on it.
If we look down the road and see an environment where the industry is, in fact, practicing under some code of good practices, which are roughly equivalent to CGMPs, what role, if any, would you see for the FDA in that environment, in that context?
MR. BOSSMAN: Clearly, you would be the parent. They would have to be your codes. You would be the overseer of the overseers.
DR. BLACKWELL: So some inspections would continue, maybe?
MR. BOSSMAN: Maybe you could oversee the inspectors instead of you having the inspectors to go out and look at the feed mills and the third-party feed mills. You could confirm that the inspectors of these feed mills --
DR. BLACKWELL: So sort of an inspect or certification kind of program?
MR. BOSSMAN: Yes, absolutely.
DR. BLACKWELL: Thank you.
Any other questions?
MR. GORDON: Could I make one comment?
DR. BLACKWELL: Yes, please.
MR. GORDON: Because I probably was not as clear as I wanted to be in my comments earlier.
In terms of education and information, I think the industry organizations and your to her stakeholders can do a lot of good for you in terms of putting language into industry terminology and perhaps writing it in a less regulatory way and stressing the importance of compliance.
We understand your legal obligations to have to say certain things, certain ways, but I think that is a real asset that you can use in trying to extend your reach in your information and communications efforts to encourage compliance.
Hearing it from an industry organization--and Dave's organization has done a great job in this area, too--I think really carries a lot of weight with the industry you are trying to regulate in a prudent manner.
DR. BLACKWELL: So we can just translate that to say that you would take what these lawyers write and make it understandable?
MR. GORDON: Your stuff is pretty understandable. I do not mean to imply that at all.
DR. BLACKWELL: Sorry, Dick Geyer.
MR. BOSSMAN: You have to give them the last word.
DR. BLACKWELL: I must say here, it does amaze me after 20-plus years in the agency how we can sometimes look back. I have been able to look back at a letter that I wrote, and I do not know why I said it the way I did. I do not even understand it anymore.
That is an interesting suggestion. I think it couples with a lot of things we have heard so far, and that is a specific role that the industry could take in helping to communicate FDA decisions or policies in particular and certain requirements.
Any other questions, comments?
[No response.]
DR. BLACKWELL: Then we will move right on to Dr. Hanks.
DR. HANKS: Thank you.
I am Alan Hanks. When I am not working for AAFCO, I am the State chemist in Indiana, located at Purdue University.
For those who do not know, we do not have a State department of agriculture in the State of Indiana, and we have most of our regulatory programs located at Purdue.
AAFCO, which I am representing today, is basically an association of State regulatory officials, but it also includes the FDA, CVM, and AAFCO's name is the "American Association." So, basically, anyone in the Americas would be welcome. In that case, we do have Puerto Rico, and actually, very recently, Costa Rica joined the association.
The association works primarily to establish model laws or model legislation that the States or other members may adopts. I need also to emphasize that the association works very closely with industry. We have numerous committees, and there are industry liaison members on all of those committees.
I say that in part because you will hear a reiteration of at least two points you have already heard from industry organizations.
During the pats few years, AAFCO has come to emphasize feed safety as an integral part of its regulatory philosophy. A major function of feed regulation is to safeguard the health of man and animals. Standards must be set for substances determined to be unsafe in feeds, and analytical methods are necessary to determine when standards have been breached.
Products which contain unsafe levels of substances or labeled such as to be potentially used unsafely may be harmful to animals being fed while posting a threat to humans and the human food supply.
AAFCO relies heavily upon a strong science-based standard setting and support activity of CVM in limiting mycotoxins and other standards in feeds. Standard support needs to continue whether by participation by CVM in CODEX or independently by CVM, if, through CODEX, we must make sure that such standards are, indeed, science-based.
AAFCO feels CVM needs to devote necessary resources for development or selection and validation where needed of analytical methods for detection, especially of certain potentially high-risk feed contaminants in the name of feed safety. This is an area where, again, CODEX could be a source of methods, but only if those methods are sufficiently and adequately validated, or perhaps even third-party contracting for such methods is potential for the future.
AAFCO's strategic plan for 1996 through the year 2000 makes feed safety its top priority. Emphasis is basically feed safety equals food safety in ongoing regulatory programs. The emphasis here includes development of strategies covering process control.
Feed safety must include safe manufacturing of feeds, accurate labeling, while guarding against contamination of pesticides, mycotoxins, industrial chemicals, and various microbial species. Manufacturing process controls are especially critical in safe production of medicated feeds and are found in the good manufacturing practice inspections of licensed and unlicensed medicated feed mills.
Equal inspection vigilance at both types of medicated feed mills, licensed and unlicensed, is required to ensure safe, uncontaminated feed.
You have heard from National Grain and Feed Association, their interest in the support of citizen petition, review and processing, and in particular, one was mentioned concerning the revision of the current good manufacturing practices. A petition has been submitted both by AAFCO, AFIA, and GFA for that particular revision. We would very much like to see that occur.
In the same vein, I will mention very briefly the program that you have heard today of the voluntary self-inspection--or self-certification through self-inspection of manufacturing of animal feeds. That program, VSIP, which was somewhat inspired by a member of the FDA panel, at least in though and concept, Mike Rogers, is also a component of the AAFCO's model, medicated feed program, which is currently in draft form. A component of that is also the revised good manufacturing practice inspections.
AAFCO supports a program such as VSIP where a third party would be involved primarily in the certification and oversight of the inspectors, with training ongoing either by the oversight certifying organization or basically through trainees or trainers selected from both the States, FDA, and industry.
I do not think I lost a page. I just lost my place.
I would like to speak a little bit to priority-setting. In priority-setting, State and Federal programs need to work more closely together or at least know and understand the basis of each other's priorities in regulation of animal feeds.
Often States find a reasonable high priority for them may be a low priority at the national level, perhaps for lack of resources. Equally, States may not have a clear picture of national priorities or lack a clear appreciation or understanding of the basis for such priorities.
The States, probably through AAFCO and CVM, need to review together where possible and coordinated feed regulatory emphasis and priorities.
While for many reasons, such is variations and goals that you will find at some State feed programs, it is not likely that we can always much all priorities at the State and national levels. However, we all do need to know and understand each other's priorities. We may all be able to share our resources and support each other if we start early setting our priorities in planning processes.
Also, in regard to priorities, there is a trend today for inclusion of unimproved ingredients and sometimes extraordinary claims on labels of some animal feeds. States may act individually to police these problems, but greater and wider successes can be achieved with strong support from CVM.
Admittedly, in most, if not all cases, high risk to animals and humans may not be at stake, but truth and legality in labeling is in question. The States have long been the guardians against fraud and mislabeling claims in the regulation of animal feeds. We believe we could be more effective in this area with stronger FDA support.
Finally, in summary, several areas mentioned here, standards setting for contaminants, provision of analytical methods, support for review of petitions on the backup of States in the area of fraud can only be acted upon if CVM has adequate funding and other resources to help support the States.
In some instances, research is required which likewise needs funding. Thus, in general, for feed safety and, in particular, in support of the States who perform the bulk of inspections, sampling and analysis of animal feeds, AAFCO strongly supports adequate funding and resources be available to CVM to be used accordingly.
I recognize the problem with resources. Simply, AAFCO supports greater resources, if necessary, to perform those things necessary to support the States.
I want to thank CVM for holding this program, for the opportunity to be here to represent AAFCO.
Thank you.
DR. BLACKWELL: Thank you. We appreciate that feedback.
Any questions?
Mr. Geyer.
MR. GEYER: Mike, after your comments earlier about how lawyers extend the program time, I decided I would not ask any questions this afternoon, but I have changed my mind.
DR. BLACKWELL: Rich is talking out on you, I will tell you.
MR. GEYER: Well, he has done that before.
[Laughter.]
MR. GEYER: I thought if I spoke, Wanda would probably raise the red paddle, and it would be all over, but I have just got to ask a question to Dr. Hanks.
In the process of contracting for inspections that the States do and the development of partnerships and training that FDA/CVM might provide for the States, do you have any comments or suggestions for us on improving those processes?
DR. HANKS: I think perhaps instead of the processes, per se, although the processes might be improved, and I think perhaps co-training programs with a good deal of both CVM and State input would be of value, but I think the frequency and the number of locations is fairly critical in this area and would be important.
Most States cannot send all their inspectors, at least not very far, and we send only our chief inspectors. I have a very good chief inspector, but every chief inspector, I know, is a filter. I would like to send my entire inspection staff when I can.
MR. GEYER: Thank you.
DR. BLACKWELL: Glo?
MS. DUNNAVAN: Alan, I would just like to ask one question. This is kind of for me personally maybe--I have just fairly recently gotten involved in AAFCO and attending the meetings and seeing what is going on. I am very impressed the way that organization works.
I am just curious about how you feel CVM's involvement in AAFCO is. Is it good, bad?
DR. HANKS: Well, it is very good. I may have sounded critical, but please do not take it that way.
So far as the activities of AAFCO, it is very important to have CVM involved. We greatly appreciate the activity and resources that CVM does devote to that.
MS. DUNNAVAN: Thanks.
DR. BLACKWELL: Other questions or comments?
[No response.]
DR. BLACKWELL: Okay. We will move on to Dr. Zimbelman.
DR. ZIMBELMAN: Thank you.
I am Robert Zimbelman, representing Federation of Animal Science Societies, which is a new federation this year. Prior to that, I was 10-1/2 years as executive vice president for the American Society of Animal Science, and that position was stopped and evolved to this position.
I told them that since I will be 68 this year, I will retire and would not be an obligation. They asked me to help make the transition for one year. So you are hearing me during my last year of work.
Prior to that, I was with the animal health industry for 27 years. So some of my comments are obviously impacted by that experience, and if the 11 years I have been sort of away from it, I have gotten out of touch. I congratulate you, and you can let me know, but I would suspect some of the things are still pretty much the same.
We are choosing to comment today, and we appreciate the opportunity to focus on the issue of ensuring an appropriate scientific infrastructure and the ramifications this has.
I guess that is basically Question 4 of the FDA list. Legislators, regulators, and the general public all support the science-based decision-making process. I think we need a new mantra, maybe. We are for motherhood, apple pie, and science-based decisions.
Both sides often claim to have science on their issue, though, when there are sides of an issue, and how to achieve this science base is more difficult than the implications of the understanding and clarity that are in that statement.
It is sort of as if there is a single scientific consensus, and it is always evidence, and it can simply be applied to a given situation. In reality, science is a constant process of challenging the current dogma, reevaluation of what is known, what data exists, and what is the individual interpretation of various knowledgeable scientists.
It becomes even more of a challenge when non-scientists choose a favorite interpretation or select certain data out of context to make a point favorable to their interest.
It is also possible to find a given scientist who might support a minority rather than a consensus interpretation of any given study or set of data. So determining the consensus is really sometimes a challenge and more difficult.
Let me give you some examples. Toxicology studies. Toxicology is, after all, biology. Over the years, there has been a tendency to require standardized tests, and partially, this is defensible on the idea that various drug sponsors should have similar challenges.
In some cases, however, there is an adequate biological understanding to modify the proposal, to provide a more meaningful set of results. This seems unlikely to happen, though, unless the scientific expertise and justifications allow it to happen and can permit it to happen.
In addition, some persons have concluded that small doses of exposure to large groups of animals are uneconomical and infeasible. So they propose large overdoses of drugs to reasonable groups of animals as an appropriate model.
I can tell you, as a biologist, a million times overdose to one animal is not the same as one ex-dose to a million animals, and neither are the thousand or 100-kind-of-fold overdoses to those kind of groups of animals typical. The drug interaction or inactivation and excretion are obviously different at those doses.
It is greater than mathematical numbers. People do this to try to get numbers, and then use those numbers to characterize a drug.
Particularly with toxic substances, that is, substances that are toxic at a low dose, the long-term studies in are done at doses that do not reflect that toxicity, and those may be the primary effects.
Other substances which are basically non-toxic and can be tolerated in extreme overdoses may have profound biological effects, however, that are interpreted as cancer and things like that. So, in some ways, that process penalizes non-toxic substances over toxic ones in certain instances.
Let's go to efficacy studies. As with toxicology, a standard set of studies for efficacy may fail to be the best course of action for drugs that have markedly different biological endpoints and modes of action. I believe the ADAA was intended to provide some flexibility in designing more appropriate studies to evaluate efficacy, and it appears there is difficulty in implementing that or it has not happened to the extent hoped at least.
Third, let's go to risk assessment. Risk assessment is a vital first step to risk management and risk communication. This is particularly true for issues such as food safety, residues, antibiotic resistance, and other issues of concern to the public, but risk assessment involves trying to search for a number and a desire for public and other groups to have a definitive figure is always great.
The relative risk also depends on the level of exposure, but as I stated above, the toxicology results are always going to have some degree of uncertainty, as well as will the potential exposure, but in this day and age of computer capability for handling large amounts of data, it is tempting to have great confidence in certain numbers that might result from massive manipulation of the data by a computer.
The assumptions that go into such models are likely to be crucial to the final interpretation. Most often, the biological understanding of a given drug will likely influence any interpretation of the risk.
For example, with antibiotic resistance, there are at least three biological mechanisms involved in development of resistance. There is chromosomal, plasmid, or transposan.
Also, resistance to certain drugs confers resistance to other drugs, and resistance can be interpreted in different ways. Does this mean it is totally inactive, or does it mean that the effective does has increased by four-fold or ten-fold or something such as that?
So, if you just ignore all of these factors and just develop a figure, it is probably not going to really be predictive of what we should be concerned about.
So I think the biological considerations, again, need to be taken into account and do not make this just a mathematical exercise.
So I see it that FDA/CVM needs to expand its scientific base for making and defending such complicated decisions. Perhaps it could seek assistance from professional associations for assistance in trying to assess a scientific consensus on these issues.
New drugs are developed by a broad variety of scientists, depending on the specific drug discovery program. These often include chemists, pharmacologists, physiologist, immunologists, microbiologists, nutritionists, biostaticians, and others. Animal scientists are often involved in field or other studies which confirm efficacy and target animal toxicity.
If I look at the CVM Advisory Committee, it does not appear there is adequate representation of such scientific disciplines. Most of the decisions in recent times, as I see them, appear to be focused on clinical application and control of drugs. Clinical judgments and experience are vital factors in the proper use of certain drugs, but the scientific underpinning may be more important in consideration of public health aspects.
Mechanisms to get such scientific input are important as well as mechanisms to update the scientific capabilities of CVM reviewers, as the science base changes rapidly with time.
This day and age, people's careers last longer than their field of knowledge that they had when they were in graduate school. So there needs to be some kind of updating of the scientific capabilities of CVM reviewers.
We want to compliment Dr. Sundlof and his staff for the past level of interaction with the American Society of Animal Science. They usually have an annual meeting of what they call the Regulatory Agencies Committee, usually in March, and he and his staff have been very willing to participate in that. In addition, we usually have symposia at the annual meeting, and they have been very forthcoming in participating and informing the scientific community of pertinent issues at that time.
I think there have been a lot of changes in CVM in the last few years, but I think some of those issues I raised probably are still there to some extent.
So I will be glad to take any questions, and again, thank you for your time.
DR. BLACKWELL: Thank you.
Any questions or comments from the FDA?
Dr. Sundlof?
DR. SUNDLOF: It is not a clarifying question, but, Bob, I just wanted to say that I think you have articulated about as well as I have heard.
The environment that we are in, trying to make regulatory science-based decisions, where the science is uncertain and where there are competing camps within the scientific community is very, very difficult, and I think you have really characterized it well.
DR. ZIMBELMAN: Thank you.
Could I--
DR. BLACKWELL: Please, go ahead.
DR. ZIMBELMAN: I think this group needs a little bit of humor.
DR. BLACKWELL: Thank you.
DR. ZIMBELMAN: This is not picking on Kim Goss, although it might seem like it, but there is a story of a very famous person--let's just say a congressman--who had a speech writer, and the speech writer was getting increasingly frustrated with time. The congressman would come back after the speech and complain about the speech, and the speech writer said, "Well, if you would just review it in advance, I would change those things that you see as a problem." He says, "No. I am not going to take the time to do that, but I want you to do better."
So, finally, the speech writer decided he had written his last speech. So he prepared the speech, and he was getting it on and coming to--I don't know what. Maybe complaints about FDA or something, and the congressman was stating, "And there is GRAF out there and they are inefficient in doing their job, and let me tell you about the perfect example now that documents all this," and he turns the page. In big letters, it says, "Now, you S.O.B., you are on your own."
[Laughter.]
DR. BLACKWELL: That is good. That is actually scary.
[Laughter.]
DR. ZIMBELMAN: Only for people who have speech writers.
DR. BLACKWELL: I am looking at my special assistant over there who does a lot of that for me, and I have that bad habit. She is so good.
Carol, please do not do that, all right?
Dr. Graber?
DR. GRABER: Thank you.
Bob, I just want to make sure I understood your point. Am I correct in stating that your position is you think not only the composition of the Committee needs to change, but, more importantly, the issues that the Committee addresses needs to change?
DR. ZIMBELMAN: Yes. I guess it comes from when I was in the animal health industry. I was active in AHI, and I think when the idea for that generated, it was to do what Steve sort of said and say can we set up a panel that might help with determining the scientific consensus, but I think as it was finally--that was the original objective, I think, and probably not many people in this room even were around then to remember that.
I think it is a different kind of panel. I guess what I was trying to say, I think if that was the original intent, but that is not what they have been doing in my opinion, if you need that kind of help, if there is a need for sort of sorting through these complex issues and saying this seems to be the scientific consensus, there needs to be another panel constructed a little differently.
The one that is there probably advises well on the issues that they are capable of advising on.
DR. BLACKWELL: Any others?
[No response.]
DR. BLACKWELL: Well, we did save the best for last. Put a little pressure on you there, Jim.
Dr. Jim Jarrett is going to come forward and talk with us, and then we will try to get ourselves wrapped up for today.
DR. JARRETT: Thank you, Michael.
For the information of those in the room, AABP, Bovine Practitioners, is at this position on the program as a result of our action, not theirs. We would likely have fit better earlier in the program, and we appreciate the opportunity to be a part of this.
I spoke with Dr. Blackwell earlier this week, and we did come into the play late. It was our fault.
My name is Jim Jarrett. I am the executive vice president of the American Association of Bovine Practitioners, America's cattle veterinarians. I also continue to do a little bit of on-farm veterinary practice work. So I come to you today with a little bit of manure on my boots as well.
Dr. Sundlof and I made a rather major career change at about the same time a few years ago. There is no doubt in my mind, I know I got the best deal. I only have 5,600 bosses, and I cannot figure out how many he's got. All of mine have essentially the same vision and the same goals, and I cannot figure out--I have about decided every one of his has a different mission and a different goal. I do not think there is anyone that I respect any more than Michael and Steve Sundlof and the people at FDA and what you do for us.
Bovine Practitioners are a part--we know that all of our patients are a part of the food chain. The most valuable purebred bovine in this country is only one conception away from a McDonalds. So what we use in these animals is extremely important.
Our mission is to provide the safest, most wholesome food from products of animal agriculture that we possibly can. To do that, we need safe, effective therapeutic agents and devices to work with our clients and to ensure food safety.
I am sorry that they ran out of hamburgers at lunch, Dr. Sundlof, and you had to eat that other meat. I do hope that you had a glass of milk with that sandwich, or whatever the meat was.
DR. SUNDLOF: I had cheese.
DR. JARRETT: Cheese. Okay, that will work.
[Laughter.]
DR. JARRETT: As a result of the efforts of many people in this room and the groups that we represent, America's consumers have today the safest, most wholesome food supply ever known in the history of mankind.
We hear reports of all the antibiotic resistance and so forth, and yet, depending on whose report you read, the actual problem related to this to date is not that great.
We hear about all the residue problems with drugs in animals making their way into human foods, but the actual problem today is not that great.
Several times, I have looked for a reported human illness or death as a result of any compound that has gone from a bottle into a cow, into the milk, and into the human, and it is extremely hard, if not impossible, to find.
Now, having said that, it is not the time to let up. It is not the time to reduce our efforts in this area, and we must all always continue to be on the lookout and working toward even continuing to improve the safety of this food supply we have now.
So now, to the reason we are here today--and it became very tempting to say, "Me, too," and sit down, but I will not do that, Michael. We are here today to try to help FDA/CVM increase its efficiency and reduce the cost of the service it extends to our society.
It is real easy for all of us as stakeholders to stand up here and look across the fence and tell our neighbor how to raise their kids, when, in fact, these people are on the firing line and need all the help that we can give them.
What I am going to do is discuss three ideas or three topics that my volunteer leaders suggested I discuss today as possible areas to reducing cost of the efforts of CVM.
Number one is in the area of the drug approval process. No doubt that we now have a very complicated drug approval process. As a practitioner in the early '60s and ever since then, I have from time to time been involved with clinical trials. There is no doubt that the activity in that area of drug approval in the '60s was not sufficient to either supply us with safe drugs and/or protect the public from residues and so forth.
However, I wonder sometimes if that pendulum may have swung too far in the other direction now, and I use as a specific example the drug trials that I did in the '60s required very little recordkeeping. A lot of opinion was involved, and admittedly, not the best service to the consuming public was given.
On the other hand, the most recent one that I was involved with was so intense and so detailed that if a cowboy or a herdsman out in a corral saw a cow in estrus or in heat and happened to write that cow's number down on the back of a matchbook cover, that matchbook cover had to become a part of the record of that trial.
Now, somewhere in the middle of that, we need to find a happy medium that we can serve society and still get the information we need.
The intentions are certainly good. I have no question as all with the intensity that our drug approval process has come to us. I sometimes wonder how much of this intensity has been as a result of pressure put on by groups with marginal knowledge about what our industry is all about.
If you go to the dictionary and look up the word "safe," nowhere in that definition will you find the phrase "risk-free."
I flew here on a safe airplane, but I was not risk-free. We eat the safest food ever known to mankind, but it is not completely risk-free.
Are there areas and activities that CVM does that might continue to work on risk assessment, as has already been discussed, and someway or another reduce the cost of the overall drug approval process? I do not know, and this, I will refer to a little bit later as well.
There has been some discussion of partnerships in the drug approval process, and we need to remember that partnerships include trust on both sides--trust on both sides. No partnership will last unless both sides trust and have faith and confidence and respect for each other.
So, if partnerships are developed and there is a lot of potential for them to reduce the cost of CVM, then there must be equal trust on both sides.
I look at compounds as an example to reduce the approval process, compounds that have very little or no impact on human health, as an example, parenteral fluids, that must go through rigorous testing in order to get approval, or compounds that have had previous approval, as an example, some of the compounds currently in the pipeline that need only minor labeling changes and yet have to go through a complete new approval process, realizing that many of these regulations and many of these hoops that these products must jump through have been forced on CVM from outside sources as well, but are there some of these areas that we can look at and possibly reduce this cost of the drug approval process?
The one-drug/one-bug policy can be a problem, and I use as an example metritis in the bovine. That is a highly complex syndrome, usually and quite often caused by many different bacteria, and to date, we do not have a single approved product to treat this syndrome in cattle.
There has been some discussion of user fees. We have concern about how user fees might be applied and might be used, and will they become just another tax? If user fees come in, will funds be released to, in turn, do some of the other things that need to be done, or how will this funding be used? Concerns from some of our volunteers.
The second area I want to talk about briefly is that of education and communication. We at AABP, and I feel sure, Swine Practitioners, AVMA and NCBA, and all of the professional and commodity groups stand ready, willing, and able to do what we can to help CVM communicate with the end users of your technology and your information.
We would be happy to be any part or any way that we feel like we have the pipeline and the conduit to deliver information to the end users of the regulatory process and stand willing and able to do that at any time.
The challenge is getting all of us involved and having all of us understand each others problems. I would use my experience as a dairy veterinarian and the fact that years ago, I realized that in order for an animal health program or a herd health program to work, it had to be executed at the level of the guy in the milking parlor. I wonder sometimes if there is not some areas that we could improve in communicating in the area of where the rubber hits the road, the guy in the corral communicating with the person at CVM who is actually working on these regulations, and is there a possibility to improve that as well.
I was encouraged and enthused about what Dr. Sundlof had to say in the investment work in what he talked about earlier.
The third area, quickly, has been covered by almost everyone, and that is the area of regulation or compliance or enforcement. We have concerns about the way enforcement is done, and wonder sometimes. We all know that, unfortunately, many must sometimes suffer for the activity of the few. There is no doubt that within our industry, most of the problems are caused by a very low minority.
However, would the possibility of increased enforcement and making an example of a few in turn reduce the cost of some of the overall efforts that CVM does? Unfortunately, it s the activity of these few that makes its way to "60 Minutes" and "20/20," and it is unfortunate that it is the efforts of these few that the consumer groups, such as represented in this room, may use to judge all of us by. So, in reducing some of these things, is there a possibility of doing it through enforcement and thereby not making some of the strict regulations as necessary?
So, in summary, my compliments to the FDA/CVM for what it has accomplished and what it is doing. I thank you for the opportunity to be here.
To repeat, we would like to see efforts made hopefully in the area of simplifying the approval process and reduce cost there, of using the existing systems to communicate and with the industries and the stakeholders involved, and to increase the enforcement presence at most levels.
Thank you.
DR. BLACKWELL: Thank you, Jim.
FDA?
Please, Dr. Sundlof.
DR. SUNDLOF: Jim, I want to clarify what I think I heard you say regarding the enforcement activities. You are suggesting that CVM take strong enforcement activities against those ne'er-do-wells who are willfully violating some of our regulations as a way of making examples of those individuals. Was that correct?
DR. JARRETT: Yes. And I hear that repeatedly from my members.
DR. SUNDLOF: Okay, thank you. That is helpful to me.
The other thing is, did you indicate that we make regulations that are designed to get those 5 percent, when 95 percent of the veterinarians out there are trying to do the right thing? Are we writing our regulations to get at the very small percentage of veterinarians who maybe scofflaws versus we should be making our regulations that really speak to the 95 percent or more that are trying to do the right thing?
DR. JARRETT: I think I meant that to be more of a global philosophical statement in that not only your regulations, but speed limits and almost every regulation that we live with in society is almost or most frequently made to regulate the few, rather than the many.
The many want to do right, anyway, and I did not mean that in a specific sense as much as a global philosophical statement. Realizing what you guys have to go through with--no, I do not realize what you have to go through with, but knowing that your pressure comes at the people who break the law more than it does the people who abide by it.
DR. SUNDLOF: Thank you.
DR. BLACKWELL: I have one question, Jim, for clarification, and I am going to use my words. If I miss the mark, please correct me.
If I understood you correctly, one way to provide a bit of relief in this whole process is to factor in more directly the fact that you have a trained professional, the veterinarian, between what the FDA is trying to do and what happens with respect to target animals and the end user, and this should somehow reduce the level of effort on our part because we can factor in that professional.
I know you did not say it quite that way, but that is what I thought I heard.
You mentioned being there in the parlor, and maybe you were referring to the producers and/or the veterinarian. Could you elaborate on that?
DR. JARRETT: Okay. First of all, thank you. I did not say it, but that sounds like a heck of a deal to me.
[Laughter.]
DR. BLACKWELL: Okay.
DR. JARRETT: And I agree, by the way.
DR. BLACKWELL: All right, good.
DR. JARRETT: I think my point was, though, when I mentioned the person in the parlor was the fact that regardless of how well we in this room think we are going to execute a program, it is the person out there where the rubber hits the road where it is actually going to get done.
DR. BLACKWELL: Yes.
DR. JARRETT: In the case of the feed industry, it is the guy down there running the mixer that can mess us up more than anything.
In the case of my professional experience, it is the guy in the milking parlor milking the cows that can do it the worst and mess up the best-laid plans of mice and men.
My suggestion was that we look for ways to help those level of people communicate with each other, and i do not mean that to be judgmental in anyway, but the people in CVM that do the work, that actually read all of these volumes of information that come in, have they ever been on a farm? Do they know what it is like to be in a feed yard in a dairy farm or whatever? Can they at least in some way appreciate? And if that appreciation was there, would it cut down on the amount of man-hours they need to reach a decision?
DR. BLACKWELL: Okay, thank you. That is definitely different from what I--
DR. JARRETT: Yours sounded better than mine. So we will use yours.
DR. BLACKWELL: They are two different points, but I do understand what you are saying. It is feedback we have heard before. I think you guys continue to push that one on us that we need to become more informed about how the real world works in order to better make decision that we have in front of us to make. Is that a fair summation?
DR. JARRETT: Yes, good. One more time, you did it great.
I have the greatest respect for Michael. Did you see he walked up among the lawyer talk, without the slightest bit of fear or anything? He just jumped right in.
[Laughter.]
DR. BLACKWELL: See, you are going to start something because Dick was going to let it all guy until you said that.
Any other questions from FDA?
Mike Rogers.
MR. ROGERS: Yes. This is not for Dr. Jarrett, but three of the panelists have expressed support for the voluntary self-inspection program, and one of the theses of that is to increase our uniformity.
This being a meeting about resources, there is a tremendous cost associated with certification. I just wanted to know what role, if any, do the industry members see themselves playing in developing a certification program for investigators.
MR. BOSSMAN: In development or implementation?
MR. ROGERS: Either. I believe that the AAFCO organization has laid the foundations, but in the Office of Regulatory Affairs, we have had some experience with certification in the device program. It is resource-intensive. If there were some roles that you might see for yourself, that could help to unburden the Center and certainly the field and what we might expect we would have to do to create a certification program for medicated feed inspectors.
MR. BOSSMAN: We certainly have been and will continue to be supportive in development of the certification program. So I am not sure what part of the cost to development that as it relates to the agency. From a manpower standpoint?
MR. ROGERS: Well, I think delivering the training. There are levels of training that are proposed in the concept paper, and delivering that training is going to be costly for someone. To the extent that that responsibility could be shared, I think it would certainly encourage us.
MR. BOSSMAN: I think the industry would be more than willing to share in the cost of the training for that program, absolutely.
MR. GORDON: Mike, I think the other thing that industry could offer here, pursuant on the acceptance of the certifying organization, is faculty members from industry that might be willing to come in and serve as instructors with the curricula of however the certifying organization wants to present that. So, in addition to monetary resources, there could be human resources that could be brought to bear there, too.
MR. BOSSMAN: I think at the conclusion of all of that, it certainly should be cost savings to the agency for a voluntary inspection program. It certainly should have that as a goal.
If we build it so that it is not, I think we are building it wrong.
DR. BLACKWELL: Any other questions
[No response.]
Questions and Comments from the Audience and
Summation of Major Points from Panel Discussion
DR. BLACKWELL: If not, we are going to open this up and invite members of the audience to share any comments or opinions.
Yes, please.
MS. COOK: Good afternoon. I am Nancy Cook with the Pet Food Institute, and I want to take a page from George's book.
George, I had not planned to talk this afternoon, but since you brought up enforcement, I just thought I would. It is a little referral to our last meeting.
The Pet Food Institute represents manufacturers of approximately 95 percent of the dog and cat food that is produced in the United States. It is a $9.5-billion industry.
I would suggest to CVM that we would appreciate in their priority-setting program that we reestablish the FTE in place that was designated as pet food specialists at CVM.
There are two portions to that, that we feel are appropriate. One is that it is a tremendous resource for the pet food industry. The second is that it is a tremendous asset to Gloria in the work that they do in compliance, and that is our second portion that we want to visit about today. We will file some very detailed comments later, but compliance is an area, as Dr. Jarrett said, in which 95 percent and 5 percent is where we have problems just like everybody else does, particularly in the areas of non-GRAS products, unapproved feed ingredients, arbitrary and unprovable drug claims, and also what we have currently undefined in nutriceuticals. This also includes holistic drugs, holistic products, that to this point have never been included in any kind of pet food regulation.
We would appreciate support from FDA. We appreciate the support we get from FDA. FDA has done a tremendous job in working with USDA and with our industry in helping us to develop the international trade responsibilities that we have, and that is another billion dollars in trade. We do appreciate those efforts, and especially the efforts of Dr. Sundlof and his group earlier this year in enabling us to continue our exports to Great Britain. Thank you very much.
We appreciate your efforts, and we just look forward to a very fruitful and beneficial relationship. Thank you.
DR. BLACKWELL: Thank you.
Any questions? Other comments?
Yes, please.
MR. MILLER: I would like to maybe clarify on what I had spoke about earlier today and also address it to this panel. It seems like they would be more directly related to the comments that I had.
I am Pete Miller with EQUI AID Products. My experience has been that the approval process for drugs is very labor-intensive and rigorous, both for us and the FDA, as compared to the surveillance end of things, and especially with regard to the likelihood of a problem, let's say, associated with an industry that is attempting diligently to comply with regulations to follow the thing, to do good manufacturing and those sorts of things.
We work diligently with the Food and Drug Administration, and they work back with us, but it is very cumbersome, very time-consuming, and we feel like the resources could be redirected from there. Maybe the level of scrutiny would not be quite as much as it is. I have got very specific things, if you are interested, that we could discuss on that.
On the other end, the surveillance, especially of companies that do not make any attempt to comply with any of the regulations, is essentially zero in our experience, and so while we were going through what I would consider a rigorous approval process, there are other people that we rather pointedly made the FDA aware of that were manufacturing exactly the same product with no approval at all, and nothing was done. We felt like that was a major problem, and it is a place where resources could be reallocated.
In addition, the product that we were working on was a well-known compound, with formulation being essentially a non-issue because of a medicated feed issue in that once it is approved, it can be manufactured in any finished formulation of feed. So the issues around bioquivalents and formulation has got a very long history of safety. So those are sort of minor, and they tend to, in my opinion, give FDA a comfort level that might not require the intense scrutiny that perhaps, let's say, a human chemotherapeutic that is very toxic in a geriatric application company.
So I do not know how you distinguish that, but I do know that allocation of resources with the real potential that they would have to produce a negative impact on the consumers' efficacy and safety should be in your thought processes when you do that.
Those are my comments.
DR. BLACKWELL: Thank you. I appreciate that.
Any others?
Dr. Mitchell?
DR. MITCHELL: Well, I thought I would try to seek a little clarification. This is on interdepartmental communications. We heard reference to this, this morning, about the need for discussions, particularly with respect to research, ARS and CREES.
This afternoon, I think we heard Randy Gordon say something about consultations with departments that have other functions, and I thought I heard you say the Trade Office and maybe others having to do with international. Could you clarify or expand on your comments and what you were thinking there?
MR. GORDON: Well, I think the agency has provided a good technical resource base for the Foreign Ag Service, particularly in trying to combat EU non-tariff trade barriers, where they are trying to set up requirements that commercial mills in this country that export feed to the European Union would have to be inspected by European inspectors, for instance, and even though they undergo FDA inspections and certification of their experts by the FDA.
I think for FAS to have that kind of knowledge base to go to FDA not as the lead agency in arguing this case, but for supportive documentation and arguments that they can use with the European Union in combatting this kind of blatant non-tariff trade barrier, it is very helpful.
I think as we get into an increasingly competitive global market, we are going to see more cases like this coming to the forefront. Again, respecting your limited resources, I am not asking FDA to be the lead agencies in these because FAS has the contacts in the international community to resolve these sorts of things, as does the U.S. Trade Representative's Office, but to provide a supportive backup role in giving then the information and the knowledge they need to effectively argue the U.S. case.
DR. BLACKWELL: Any other comments, opinions, suggestions for us?
[No response.]
DR. BLACKWELL: If not, I am now going to run through this list that summarizes the major points made during this panel. Again, I want to thank all of you for taking time out of your schedules to be here and give us this feedback.
We think that there was a slight suggestion that there should not be user fees.
[Laughter.]
DR. BLACKWELL: Oh, okay, all right. You were very forceful about that, and, yes, we did hear you.
There was, however, some more specific information given, and I think the comment was that maybe under some special circumstances and through certain arrangements, there may be a way for financial support to be derived from the industry, but that needs to be discussed.
There is support for third-party inspections, again, a need for further development there. There were several references to the program that Mike Rogers has going, and we do hear you loud and clear on that point, the certification and so forth that is needed to make sure that there is uniformity. Right now there seems to be or you feel certain that there is a lack of uniformity both in quality and quantity of field inspections.
Both State and Federal programs should be better coordinated, and we need to be collaborating closer with the States to better understand our relative priorities in this area.
Critical for CVM to make science-based decisions--continue to make science-based decisions. It says critical for CVM to make science-based decisions. CVM should partner with trade organizations to accomplish this, and I would like to add Jim Jarrett's comments here, probably needing to partner with the profession, the veterinary profession and the producers or producer groups so that we are also not only making science-based decisions, but decisions that have a healthy dose of what the realities are in animal production and so forth.
There is general support for CVM's involvement in international activities. We have heard a lot about that today. I think everybody wants to see that continue, and in fact, be improved.
Citizens petitions were mentioned, and it is believed that these are a useful mechanism for letting CVM know what issues are critical, but there is a general request that the Center bring closure to these pending petitions.
Education and training, as well as communication, are critical. CVM should partner with trade associations to accomplish this kind of work. I believe the associations are saying that in addition to being a conduit for this kind of information, you can also provide interpretation or at least help us in translating bureaucratese and legalese into the common person's language, so that there is better communication.
Again, an educational effort is needed there. Food safety should be the factor driving inspections. That was a very definite point made as well. On the priority scale, I guess is the way to put that.
CVM should support States in all significant areas, again, closer collaboration with the States, important to use risk assessment as a tool in the pre-approval process. I think it was also made clear that risk assessment is not about numbers only, but there is a biological component that needs to be clearly a part of this whole process.
Finally, the final point I have here is that it is important for CVM to have ongoing dialogue with external organizations to strive for continual improvement. In other words, something like this, maybe not necessarily always this formal, but many made reference to work that has been done already in the past, and that we need to continue to talk to one another in this kind of context in order to better improve.
Those are the major points we heard this afternoon from the third panel, and, again, we did capture the detailed information. Some of you made reference to other details that you have that you can submit, and we do encourage you to go ahead and get that to us by one of the means shared earlier.
It is getting warm in this room, or is it just me? I can tell, you are feeling it, too, because you have that look.
Yes.
DR. ZIMBELMAN: Michael, could I make just one change? You talked about science-based decisions--
DR. BLACKWELL: Yes.
DR. ZIMBELMAN: --to partner with trade associations. I would rather say scientific professionals in that instance.
DR. BLACKWELL: Okay. Thank you for that clarification. We probably use that term generically at times, and in this instance, we should not. We appreciate that.
Yes, please.
MS. COOK: Evidently, in tallying up all those points, we decided that enforcement action was not important in the third area?
DR. BLACKWELL: Oh, enforcement, yes, it absolutely is.
MS. COOK: I think I heard that, one, two, three, four, at least five times.
DR. BLACKWELL: Yes, thank you. In fact, all throughout the day, we have heard repeated references to that, and it should have been on this list as well, the major points made.
In fact, there was a bit of detail given with respect to unapproved products. Dr. Miller got up and made that point again as well. It is another way of saying that FDA needs to really continue to be FDA when it comes to at least illegal products on the market and whether it is the pharmaceutical companies or the veterinarians or the producer groups. I think we are hearing the same message there.
Thank you for that clarification and reminder.
Any others?
[No response.]
Closing Remarks
DR. BLACKWELL: If not, I wanted to again thank everybody for coming out. I know some have already left and will not hear this, but starting with our stakeholders, we realize that this is right in the middle of the prime vacation time for most of us at least, and there was something of a short notice. You all being very busy, it probably was with some effort to get here.
We apologize for that and really, again, appreciate your coming because this is so important to all of us. I do not know about you, but I think today has been wonderful. There has just been great dialogue. We did not even fight about anything, really. We got a lot we could fight about, I am sure, but I think it is indication of the kind of work that has been done prior to today, and I am sure will continue to occur with our working together. To see people recognize one another in any context and then be able to work together for a common good is really what this should be about. So we, again, appreciate your willingness to comment and help us with this important task.
For the FDA people who are not part of CVM, I would like to, again, thank you as well, Linda Suydam for taking the lead for the agency in this very important area, and we will certainly continue to look to Linda Suydam for leadership because, again, this is going to set the future for this agency as we try to do a better job in carrying out our mission.
There are others that I can mention, Carrie Smith-Handley, Pat Kuntze, Dr. Schwetz--not all of these people are in the room--Kathy Beck, Mike Rogers, again coming all the way from Kansas to be with us today and to sit on the panel. And you heard some good things about what you have been doing. I guess it made it really worth it, didn't it?
Jason Walters, Peter Collis, and from CVM, we really want to thank everybody how participated on our panel today. In addition, I would like to thank Carol for her effort in helping to make these summary points. She was also helped by two people in the Office of Management and Communication.
In fact, a number of people today wanted to help the Office of Management and Communication, and I was just wondering, did they plant that with you all? I mean, that is good. It just seemed unusual that so many people thought they needed to help the Office of Management and Communication, with Bob Sauer, sitting right here.
You know we made a recent organizational change, and part of the change was, in fact, to establish ourselves in this area. We had people working in the area of communication and education, but we thought the organizational change would, in fact, improve that.
So we are doing what we can internally. We heard you today saying that, hey, we think that is an important activity and you are willing to work with that group closely. So we really appreciate that.
There were a number of people up front who helped out as well, and we want to thank them.
I know I have gotten everybody because I used enough generic statements. So, on that note, we are going to call this meeting to an end, and thank you very much.
[Whereupon, at 3:58 p.m., the meeting concluded.]
|
||||||
 |
||||||
|
||||||