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U.S. Food and
Drug Administration
FDA Consumer magazine
March-April 2003
Table of Contents
By Ray Formanek Jr.
In November 2002, Mark B. McClellan, M.D., Ph.D., became the 18th Commissioner of Food and Drugs after being nominated for the post by President Bush. Prior to coming to the FDA, McClellan, 39, was a member of the president's Council of Economic Advisers and helped draw up plans for Medicare reform and other policies.
A native of Austin, Texas, McClellan was a professor, physician, and health care economist at Stanford University before moving to Washington, D.C., in 1998 to work in the Clinton administration. After a hiatus during 1999-2000, he returned to Washington and to his work as a presidential adviser in 2001. McClellan received his medical degree from the Harvard-Massachusetts Institute of Technology Division of Health Sciences and Technology in 1992. He received a doctorate in economics from MIT a year later.
Colleagues say his intensity and desire to make a difference will serve the agency well.
"His analytical skills are top-notch," says Alan Garber, M.D., Ph.D., who, like McClellan, is a physician and economist at Stanford. "He's an excellent physician and an accomplished economist who will bring new and creative thinking to the agency."
With its $1.6 billion budget, the Food and Drug Administration regulates products and industries that account for more than 20 cents of every consumer dollar spent each year.
Since Sept. 11, 2001, the FDA has played an increasing role in national security, in addition to its monitoring of food safety and its approval of new drugs, vaccines, and medical devices.
McClellan says there are "challenging times" ahead for the FDA. The future will require the agency to be "innovative and creative" if it is to accomplish its public health mission. McClellan's five priorities for the agency include: Dynamic and Responsive Regulation; Counter-Terrorism; Reducing Preventable Adverse Events; Risk Management/Smart Regulation; and Providing Better Information to Constituents.
McClellan spoke with FDA Consumer about his vision for the agency's future.
Q. In December 2002, you announced a change in industry food labeling standards for manufacturers who want to make claims that their products help prevent diseases. The new standard requires only that a "weight of evidence" must exist in the scientific community to allow qualified health claims to be made. The previous standard required that "significant scientific agreement" exist before food makers could make health claims on their food labels. What will this mean for consumers?
A. As you know, the evidence available from science about what people can do to improve their health often is unsettled. Our goal in the December announcement was to make sure that consumers have the latest science-based information available presented in a non-misleading way. I've set up a task force led by FDA Deputy Commissioner Lester Crawford and Joseph Levitt, director of the agency's Center for Food Safety and Applied Nutrition, to review our policies in this area.
In the past, the FDA applied a very strict rule about the kinds of information that would be allowed to be included on the food label in terms of a health claim.
Now, we're also going to allow for "qualified" information to be mentioned on the food label in cases where there's substantial scientific evidence behind it. That's the "weight of scientific evidence" standard that you mentioned. I want to say that this is not something I view as relaxing the standard. For claims that say a clear relationship between food consumption and a health effect exists, we're applying the same standard that existed previously. In addition, however, we're now recognizing that scientists often agree that considerable evidence exists to support a claim that hasn't quite reached a level where it will never be reversed or modified.
The point of this initiative is to have FDA scientists review claims that might be in that category. That could include things like omega-3 fatty acids in food, for example. Significant studies indicate a heart benefit from consuming a diet high in omega-3 fatty acids, and expert groups like the American Heart Association publicize the relationship, but it's not a fully settled issue.
We need to figure out if there is a way to communicate that information accurately, in a non-misleading way, to consumers. And so, we will have a scientific review effort as part of this task force.
My guess is that the task force might recommend a pre-approval process in the FDA for these kinds of food claims, just like we do in other areas that the agency regulates, to make sure that consumers are not getting inaccurate or misleading information.
Q. So, shoppers might, for example, soon be seeing salmon, which is high in omega-3 fatty acids, in the grocery store with that type of label?
A. It's possible. It would probably be a "qualified" claim that would make clear that scientific evidence suggests a relationship between consumption of omega-3 fatty acids and health. But the evidence is not conclusive.
Q. Why make the change?
A. The impetus behind this change is the fact that there is a growing interest among consumers in understanding how their diet and other activities can influence their health. The goal here is to make sure that consumers have access to the latest information, presented in a way that is not misleading, when they make decisions about their diet. If even a fraction of this evidence later becomes conclusive, we will have helped save lives in the meantime. And with the rising rate of obesity and the resulting consequences for chronic conditions such as diabetes and heart disease, it is a public health imperative to get additional accurate health information to consumers to use in their daily lives.
There also was some impetus from some recent court cases in which the courts expressed the view that the FDA was excessively limiting consumers' access to information. This step will help make clear that we're reviewing the scientific evidence and doing what the scientific evidence suggests is best in terms of giving consumers access to information. But this all relates back to the main goal of this effort, which is to improve the public health by making sure that consumers are using the best available scientific evidence to guide their food and dietary choices.
Q. You are a physician. You also are an economist. Most Americans are concerned about rapidly rising medical costs, including the costs of prescription drugs. What role, if any, does the FDA have in keeping comprehensive medical care within the reach of the typical American wage earner?
A. The FDA's statutory mandate is to make sure that medical products marketed in the United States are safe and effective. The cost of those medical products is not a direct part of that statutory mandate, and I don't expect that the FDA will start doing any kind of cost analysis in its determinations of product approvals. However, there are a lot of things the FDA can do within its mandate to help consumers get access to the effective treatments quickly, at the lowest possible cost.
For example, we are undertaking a number of initiatives related to reducing preventable adverse events in health care. There have been studies by independent groups, such as the Institute of Medicine, documenting a number of avoidable medical complications involving products that the FDA regulates. By getting a better handle on why these adverse events occur and communicating effectively with providers to help prevent them, I think we can help bring down the cost of health care by avoiding these unnecessary medical costs. Another way that FDA can help reduce costs is to improve the efficiency in the medical treatment approval process. We recently announced a set of ideas from all of the FDA's medical product centers--drugs, biologics, devices, veterinary medicine--for making our review process more efficient. Not by weakening our standards, but by using the information we receive more efficiently, by improving communication, and by providing clear guidance to those who would like to have a product approved.
Through these steps, as well as through the additional resources and authorities provided by last year's reauthorization of prescription drug user fees and through the new authorization of medical device user fees, we can make our review process work more quickly and at a lower cost.
There was a new round of studies released recently indicating that reducing review times has a substantial impact on the cost of products. In turn, that will help Americans get the treatments they need at the lowest possible cost.
Q. The time needed for the review of new drug applications submitted to the FDA rose slightly last year, after several years of decline. You have said that there are opportunities to speed up the process of reviewing drugs for safety and effectiveness before they are allowed to enter the U.S. marketplace. Can you describe in more detail some of the steps the agency is taking to ensure that promising treatments become available in the shortest possible times?
A. The product review initiatives we announced recently fall into three main categories:
First, we are going to analyze one of the major reasons for increased approval times and costs for certain products--repeat cycles of reviews. The Prescription Drug User Fee Act--PDUFA--has made great strides in reducing the time of each review cycle, thanks to FDA's improvements in review cycle performance. The major contributor to delays in the approval process now is the occurrence of "repeat cycles" caused by problems in a product application that can't be resolved by the application's deadline.
This results in multiple reviews and increases in the total time needed to make a decision on approval. We think that by looking at the "root cause" of multiple review cycles, we may be able to find ways to reduce their occurrence. That, in turn, will help reduce total review times.
A second initiative in this effort involves providing clearer guidance by disease or treatment area as to what is required for approval. We have, in a number of cases in the past, undertaken collaborative efforts with medical experts, patient advocacy groups, and others interested in our review process to ensure that we are using appropriate clinical endpoints in making decisions on safety and effectiveness.
Our center directors believe we can use these kinds of processes much more widely to provide clear guidance in a larger number of clinical treatment areas about what it takes to get a product approved. If we can be very clear about what the standards are for product approval, we can help companies, and others interested in getting a new product to market, design their clinical trials and conduct their approval studies in a way that reduces cost.
Finally, we are implementing a quality system process for medical reviews. This involves using some of the new funding and new initiatives in the third round of PDUFA to implement a total quality systems program and a system of continuous quality improvement in drug, biologic, and device approvals. It is also something I hope we can apply to animal drugs with the passage of an animal drug user fee act.
By providing clear opportunities for our staff to get needed training, by encouraging peer review of what we do internally in our review process, and by making clear what the best practices of medical review are, we can help our dedicated staff do an even more effective job in reviewing new products.
Q. Some experts say the cost of developing a new drug has doubled over the past decade. Critics say the FDA has contributed to the cost of developing new drugs by requiring unneeded clinical trials to prove that a new drug is both safe and effective. Similarly, some say that the FDA's standards for safety and effectiveness are slowing the development of new medical devices that could save lives. How does the FDA balance risks and benefits when it considers new products?
A. That's something we have to do on a continuous basis. There are risks and benefits for just about all the treatments that we approve. We need to make sure that we have an approval process that identifies those risks and benefits and that ensures the products we approve have benefits that outweigh the risks. And we need to do that as efficiently as possible.
I've already mentioned a number of steps that we are going to take to ensure that we are doing that as well as possible. One thing I think is clear from these criticisms is that the FDA can perhaps get more mileage from an effective communications effort about what we do and why. More transparency and even more attention to our communication with the public can only help the agency.
For example, one of the things I think will come out of our initiative to provide clear guidance for product approvals by disease area is a clear understanding by all those who have an interest in what the FDA does about why we set our review standards and design our review process the way that we do. There are good reasons for it. I'm sure we can continue to improve the way our review process works, but I also think we need to communicate effectively to our partners and to our critics why we do what we do so that they understand the scientific basis for our activities.
Q. You have identified several priorities as part of your vision for the FDA. Among them is counterterrorism. Can you briefly discuss some of the steps the agency is taking in this area?
A. Counterterrorism exemplifies a basic fact of life at the FDA: The job of the FDA to promote and protect the public health is one that is constantly changing and one that constantly involves new challenges.
As recently as several years ago, the watchword in our Center for Food Safety and Applied Nutrition was food safety. We had hazard analysis plans that focused on critical control points--areas that, if there were problems with food production, that's where they were most likely to occur. Now, we are taking a new look at the way we think about food safety. We now talk about food security--not just food safety. We think about not only where things might unintentionally go wrong, but also where someone with malicious intent could deliberately try to attack the American public through the food supply.
This is a new way of thinking, and it creates a more difficult challenge for us. At the same time, the underlying approach to make sure that we're doing all we can with the resources available to keep the food supply safe remains the same. We need to apply the best science. We need to apply techniques of risk assessment and risk management. We just need to do it on a broader and more difficult terrain.
Fortunately, the agency has received some new tools to do that--new statutory authority and a large number of new inspectors in the field. Now, it's incumbent upon us to rise to this new challenge to protect the food supply.
Similarly, from the standpoint of other threats to the country--smallpox, anthrax, and the like--the FDA has a critical role to play to ensure that new and effective treatments are made available as quickly as possible. We also need to ensure that we develop the information needed to treat these illnesses safely and effectively. This is an area where we're facing some great challenges. In the past, while there's been tremendous progress in the treatments for illnesses such as AIDS, heart disease, and cancer, we haven't seen the same kind of progress in treating many of the conditions that may occur because of terrorism. There wasn't a real perceived need to focus on these areas because they weren't naturally occurring threats.
The FDA worked closely with the Department of Health and Human Services and with the White House on President Bush's recent "Project BioShield" proposal, an unprecedented effort to improve our medical countermeasures.
What we hope to see in the months ahead is the same kind of emphasis on developing new and better treatments for agents of terrorism as we've seen in other areas of medical progress in recent years.
Addressing terrorism is a new and major challenge for the agency, but I know it is one that we are working diligently to meet.
Q. Both the president and HHS Secretary Tommy Thompson have emphasized disease prevention, both as a means of reducing the costs of healthcare and, more importantly, as a way to help people live longer and better lives. How can the FDA help?
A. I've already mentioned one of our initiatives in this area--our task force aimed at getting better information to consumers about the health consequences of their dietary decisions and about dietary supplements. Other areas where I think we can provide better information to help prevent diseases include making sure that patient labels on medications are as clear as possible, and making sure that patients and doctors get truthful and non-misleading information in advertising.
Q. The FDA has recently released the results of the third of three preliminary surveys it did on direct-to-consumer product advertising of health treatments. Overall, the surveys, which included consumers and physicians, indicate that the ads help increase patient awareness about the availability of effective treatments for their health concerns. What is the FDA's role in regulating such advertising?
A. The FDA plays a critical role in regulating direct-to-consumer advertising. It is our job to make sure that the ads reaching consumers are truthful and not misleading. The surveys conducted by the FDA, as well as other surveys conducted by consumer groups and others, have shown that consumers do get important information from direct-to-consumer advertising.
As a result of the ads, many people seek treatment for conditions where effective treatments exist. Many of those people would otherwise have gone without treatment. So the ads are an important source of information and an important way of improving the health of the American public.
At the same time, doctors have expressed concern that consumers don't get an accurate picture of the benefits and risks of the products that are being advertised. One of the things I hope we will continue to do with our direct-to-consumer policies is to help make sure that the ads use effective techniques to give consumers information that is truthful and not misleading.
Q. What about claims made about dietary supplements?
A. Consumers are more interested than ever in taking steps to improve their own health. I think it is actually a threat to public health when people with limited amounts of money and limited amounts of time hear misleading information about dietary supplements, and, as a result, waste their money, time, and efforts on something that will not improve their health.
I think it is very important that claims made about dietary supplements be truthful and not misleading. And for that reason, we have launched an aggressive enforcement campaign, in collaboration with the Federal Trade Commission, to block unsubstantiated claims being made by dietary supplement manufacturers. I think you can expect to see more from the FDA in this area in the future.
Q. When it comes to the FDA under your leadership, what's the take-home message?
A. The take-home message is that the FDA is here as a partner for consumers, for health professionals, and for all Americans. We are devoted to our mission of promoting and protecting the public's health. We know that to do that, there are many innovative actions we will need to take across a broad range of areas that are of interest to consumers. We also know that given all the new challenges facing the agency and limits on available resources, we will need to be more creative and more aggressive than ever in making sure that our policies are aimed at getting the most bang for the regulatory buck.
In that process, it's very clear that consumers need to be our partners. In many ways, the best thing that the FDA can do is help consumers get good information to guide their own choices about the products they use--the medical products, the dietary supplements, the food, and the choices they make concerning the risks we face today from terrorism--in order to prevent diseases and improve their health.
I'm looking forward to working with individual consumers and consumer groups to improve how we're communicating about these risks and to improve the information that consumers have. I think that is one of the best ways we can promote the public's health.