Jane E. Henney, Ph.D
Commissioner of Food and Drugs
U.S. Food and Drug Administration
for
"ASSOCIATION OF FOOD AND DRUG OFFICIALS"
San Antonio, Texas
JUNE 7, 1999
Good afternoon. It is a pleasure to be here. Let me state at the outset that I place an extremely high premium on interaction with our partners in the States. It will be by working together, in the true sense of the word partnership, that we will be able to effectively weave the all-important safety net-to the ultimate benefit of all American consumers and the public health.
From the historical beginnings of the Association of Food and Drug Officials, there has been a strong collaboration between the Agency and your organization. From AFDO's support of the original Pure Food and Drug Act in 1906, to the dramatic increases in FDA-State cooperation in inspections in the 60's, state contracts programs in the early 70's, the beginnings of partnership initiatives in the 1980's, to the tremendous successes in recent years with collaborations in our on tobacco, mammography and seafood HACCP programs-there has been a long history of our successful work together.
Under the Administration's tobacco initiative, the Agency has been successfully contracting with State and local governments to conduct compliance checks of retail outlets that sell tobacco. By fiscal year 2000, the Agency plans to contract with or have an enforcement presence in all 50 states and most territories. A program that successfully keeps tobacco from children has the potential for unprecedented improvements in public health-with our continued work together in this area, we will safeguard the health and well-being of future generations.
Another example of an extremely successful Federal/State partnership involves the collaboration on the implementation of the Agency's mammography program. While I know that AFDO is not involved in this initiative, I believe that the mammography program stands out as an example of where much can be achieved by having strong uniform standards laid out by the Federal government and carried out-at least in part--at the State level.
I would like to mention how pleased I am to have selected Dennis Baker as the new Associate Commissioner for Regulatory Affairs at the Food and Drug Administration. Dennis' credentials as former head of the Texas program and a former AFDO President make him extremely qualified for his new position-while his clear commitment to the public health and his easy-going demeanor make him a true asset for the Agency. We are fortunate to have him.
As I return to the Food and Drug Administration, I see ever-increasing opportunities for us to further strengthen our partnership and work together. The five key areas of FDA's focus are: the implementation of the Food and Drug Administration Modernization Act of 1997, the strengthening of the Agency's science base, and the Administration's initiatives on food safety, blood safety, and tobacco.
First and foremost, there is the implementation of the Modernization Act. This sweeping piece of legislation, passed in late 1997, touched on nearly every facet of the Agency's mission. With its enactment, the new statute brought the Agency dozens of statutory deadlines for the completion of regulations, guidance, notices, reports and tasks-yet, no new resources. I am extremely proud of the Agency's record on implementation of the Modernization Act-both its timeliness and its quality. Nearly every statutory deadline has been met thus far, and the actions that we have taken, many of them involving very complex issues, have been widely praised by those outside the Agency. For example, in the 18 months or so since enactment, we have completed issues ranging from regulations on radiopharmaceuticals-proposed and final, to guidance on the process for "fast track" drug approval, to completion of a petition on meat irradiation.
One specific directive to the Agency in section 406(b) of the Modernization Act was to improve our interaction with our stakeholders. Over the past year, we have held several official stakeholder meetings. This includes, most recently, an interactive videoconference that was simulcast to over 500 people in 8 different cities, each having their own local stakeholder meetings. Since my confirmation as Commissioner, I have been traveling around the country to our District offices, and have been meeting with State and local health officials, as well as our state partners from the Department of Agriculture. During these meetings, I have received a clear message that the relationship between State officials and the Agency is at an all-time high. Our collaborative efforts have helped to foster good relationships that have been and will continue to be to our benefit, and to the overall benefit of the public health.
The second priority of the FDA is to maintain and enhance the science base of the Agency. I place an extremely high priority on making sure that science underpins all of our decision-making. From the reviewer to the inspector, we can only be effective if we have a strong, scientifically-skilled workforce capable of making risk-based, scientifically-sound decisions.
The third area of priority for the Agency's work is protecting the safety of the food supply is critical to our nation's health and is another high priority for both the Administration and the FDA. The food safety problem in this country is real-and the challenges that we face are based on a combination of factors. What people eat has changed. We are now eating a greater variety of foods, particularly seafood and fresh fruits and vegetables. Transportation and refrigeration have brought us a greater variety of foods during all seasons of the year, but pose their own challenging problems. And transport of a greater number of foods from abroad, as trade barriers break down, has created new challenges for ensuring the safety of imported food.
Where people eat has also changed. No longer are we eating at home, with food prepared by our mom (or, on occasion, our dad). People are eating more of their meals away from home. In fact, fifty cents of every dollar is spent on food prepared outside the home, including grocery stores, restaurants, hospitals, nursing homes, and day care centers.
Who's eating is also changing. Nearly a quarter of the population is at higher risk for foodborne illness. This includes pregnant women, children, the elderly and the immunocompromised. The size of the vulnerable population will keep growing, with aging babyboomers and increased longevity. In addition, we are aware of more than five times the number of foodborne pathogens in 1999 than we were in 1942. Many of these pathogens can be deadly, especially for people at highest risk.
Over the past several years, the Administration has been very outspoken about the importance of protecting our food supply. The Administration has created the President's Council on Food Safety, which is charged with ensuring consistent, coordinated oversight of food safety at the Federal level-including the food safety budget and research programs. The Council oversees the strategic planning process for food safety, and Cathy Wotecki from USDA and I currently co-chair the Strategic Planning Task Force. Our work involves developing recommendations in 5 key areas:
We need your continued insights, experience and skills as we develop this plan. There will be a public meeting on July 15 in Washington in order to get input on development of a strategic plan for addressing the food safety problems-looking at both short and long-term proposals. This meeting will include representatives from industry, government, academia, and consumer organizations--I look forward to your individual, as well as organizational participation in this process.
At the Food and Drug Administration, we are taking a comprehensive approach to all of the challenges of food safety posed by the products we regulate. Our first steps have been to build a solid general foundation based on the best science. For example,-in conjunction with the Centers for Disease Control, we have developed PulseNet, a computerized database of bacterial DNA subtypes. Through the use of PulseNet, two seemingly independent E.coli outbreaks in Michigan were traced back to a common source-alfalfa sprouts. Similarly, in another instance, PulseNet helped confirm that about 50 cases of E.coli in Wisconsin were attributable to cheese curds from a single facility, after initial investigations did not reveal the source of the contamination. Through the use of science and technology some of our traditional surveillance tools are being enhanced, to the benefit of the public health.
Having developed a stronger foundation grounded in science, we are now developing initiatives that will address several issues of concern regarding areas that pose a higher risk-including seafood, fresh fruits and vegetables, and imported foods. This includes development of guidance on the safe production and handling of fresh fruits and vegetables, a proposed rule on HACCP for fruit and vegetable juices, and continued implementation of our seafood HACCP programs.
To do this effectively has required an even stronger partnership with the States. Our Federal/State integration program has its origins at last year's annual meeting of Association for Food and Drug Officials. The 50 state meeting in Kansas City in September, our working group meeting in Baltimore, the coordinating committee in St. Louis, as well as the workshop held here this past Saturday all have been focused on designing and coordinating an approach that will improve the safety of our food supply.
We are working together on many different areas--outbreak response, lab analysis and sampling, and inspections. As we move forward, it is important to keep in mind that one key to the success of the program will be to establish uniform standards at the Federal level. These standards should be high as we seek to do the best we are capable of for the benefit of the public health. Together, we will fulfill our mutual mission to protect the public health.
During the past few months, Members from both Houses of Congress and both sides of the aisle have introduced legislation that is designed to help address the food safety problem in this country. All of these bills reflect areas that Members of Congress-and thus, their constituents-feel need more attention. These proposals include increases in Federal government authority over domestic food, particularly fresh fruits and vegetables-as well as an increase in our authority over imported foods.
Another priority for the Agency and the Administration is the protection of the nation's blood supply. While recent studies suggest that the risk of acquiring an infection from a blood transfusion is lower than ever before, we must be constantly vigilant. We are clearly moving in the right direction--but we must maintain our focus if we are to merit and retain the confidence of the American people. With the recognition of not only the benefit of blood and blood products, but their inherent risk, both the industry and FDA have had to undergo vast transformations in the past decade. We are placing our efforts on ensuring that our regulatory framework for blood and blood products keeps pace with this evolving industry-thus maintaining the public health protections that the American people expect.
The last priority for the Agency is one that I have already mentioned-- the Administration's initiative on tobacco. Every year, over 400,000 Americans die from tobacco-related illnesses, almost all of whom began use of tobacco as children. The first two provisions of FDA's tobacco rule, a Federal minimum age of purchase and a requirement that retailers check photo identification, went into effect in 1997.
Litigation concerning FDA's assertion of jurisdiction over tobacco continues in Federal court. The U.S. Supreme Court recently granted the Agency's petition for cert, so we anticipate having a ruling on FDA's regulation sometime within the next year. The age and ID provisions of the rule will continue to be in effect until the Supreme Court has ruled on this issue.
Those are the priorities for the Food and Drug Administration, but-as one might imagine-that does not represent everything that everyone wants us to do. We at FDA like to think of ourselves as a "can do" Agency-but, we must be ever cognizant of the constraints put upon us by our budget. Because our funding is not limitless, we must ensure that the areas that the Agency works on are those that we have decided on through our intent, not just good intentions.
In terms of our current budget--last month, the House of Representatives held a Subcommittee mark-up on our budget for this year, with very encouraging results. Yet, while the Administration's budget request for the Agency was an 18% increase over last year, I consider it to be only a down payment on what the Agency truly needs. Last year, the Agency underwent a "gap analysis" to highlight areas where resources were needed. In developing the budget for this year, new funds were targeted for specific areas: inspections/product safety assurance, new product reviews, injury reporting, bioterrorism, tobacco and food safety-as well as money to begin development of our new consolidated facility at White Oak campus, and to begin the construction of a new facility for the LA District.
The budget includes $3 million for the States under the Food Safety Initiative-which I know Joe spoke to you about this morning. With this new request, we are attempting to fill some of the gaps that currently exist and are guardedly optimistic about the outcome as the appropriations process continues this summer.
I would like to just quickly touch on one or two other topics that will be important to the Agency. In the coming months, we will be focusing on Y2K preparedness--ensuring that medical products are as safe and available come January 1, 2000 as they are today. We are sending surveys to manufacturers regarding their level of Y2K compliance. Hopefully, the results of the survey should reveal that the public will be able to rely on medical devices and will not need to begin stockpiling drugs or other medical products.
The Internet will also provide us with some regulatory challenges. Consumers are increasingly turning to that medium to purchase drugs and medical devices-often without the advice of a physician. However, the sale of medical products on the Internet is a complex issue. Because of the difficult jurisdictional questions raised by the Internet, crossing State, Federal, and international boundaries, we will need to develop a coordinated approval to the regulation of the sale of products using this venue. There has been much interest expressed regarding this issue - at a local, state and federal level - in the Congress as well as the Administration. We are currently meeting within the Administration to determine our next steps in this area.
One last issue is the regulatory challenge presented by dietary supplements and other alternative therapies. Clearly, this is a rapidly expanding area of consumer products--many Americans place great faith in dietary supplements to maintain and improve their health.
The Dietary Supplement Health and Education Act of 1994 was passed in an effort to develop an appropriate statutory scheme that would facilitate consumers' access to dietary supplements, as well as provide FDA with the authority to remove products from the market if they present a significant or unreasonable risk of illness or injury or are otherwise adulterated.
Congress provided FDA with a great challenge under the statute-to strike the right balance between preserving consumers' access to potentially health-improving supplements, while assuring the safety and proper labeling of these products. The Agency still has a way to go in both developing a workable regulatory framework and in achieving full implementation of the 1994 law.
One factor that further adds to the complexity of this issue is that the dietary supplement marketplace has changed significantly in just the past five years since the passage of the 1994 law. The industry has grown exponentially. So has the number of Americans buying these products-surveys show that more than half of the U.S. population now uses dietary supplements, spending upwards of $12 billion per year. Access to dietary supplements has also changed. In the past, with the exception of vitamin and mineral products, dietary supplements were available primarily in health food stores. Dietary supplements were marketed principally to adults.
Now, today, a wide range of dietary supplements are available in supermarkets and via the Internet. This makes these products more readily available and marketed to children and adolescents, as well as adults. This rapidly expanding industry and changing demographic mix of consumers eager to manage their own health care or improve their health present significant regulatory challenges, many of which were not foreseen when the dietary supplement law went into effect.
Because of the many complexities in implementing the dietary supplement law, FDA is currently developing a comprehensive strategy for the regulation of dietary supplements. I would like to mention that we welcome outside input and views on how this can best be done. For this purpose, we are holding a public stakeholder meeting on this issue tomorrow in Washington, and will be holding a similar meeting in Oakland, California on July 20. If you cannot attend either meeting, you may submit written comments to the docket.
And, of course, we look forward to continued work with you in this complex area. An excellent example of where Federal/State collaboration was effective involved the GBL issue that came up earlier this year. These products containing GBL pose a significant health hazard to the public-they are associated with at least three deaths and several severe adverse reactions. Marketed as dietary supplements to be used as sleep aids, listed as "party drugs" on Internet sites, and marketed in muscle-building magazines, the products are actually a precursor to the date rape drug GHB. Our continued collaborative efforts in this area will-hopefully--prevent the future sale of these products to consumers, and thus any additional illnesses or deaths. These types of challenges will arise in the future, as together we will attempt to safeguard the public from potentially harmful products.
This is an exciting, but challenging, time for the Agency. There is always a great deal going on, with new opportunities and issues arising every day. None can be faced alone-we will need to continue our collaborative efforts. I thank you for your contributions to our past successes, and I look forward to our continued work together in the future. Thank you.
(Hypertext updated by tg 2000-MAR-21)