Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -205

Accepted - Volume 4

Comment Record
Commentor Dr. Pete Diffenderfer Date/Time 2002-07-26 02:43:28
Organization Dr. Pete Diffenderfer
Category Individual

Comments for FDA General
1. Are there arguments for regulating speech about drugs more comprehensively than, for example, about dietary supplements? What must an administrative record contain to sustain such a position? In particular, could FDA sustain a position that certain promotional speech about drugs is inherently misleading, unless it complies with FDA requirements? Does anything turn on whether the speech is made to learned intermediaries or to consumers? What is the evidentiary basis of such a distinction? All drugs and dietary supplements should be evaluated on the basis of their underlying science as discovered and validated by emperical research. Supplements that provide substantiated health benefits should not be subject to the standard FDA disclaimer which casts doubt on efficacy.
2. Is FDA's current position regarding direct-to-consumer and other advertisements consistent with empirical research on the effects of those advertisements, as well as with relevant legal authority? What are the positive and negative effects, if any, of industry's promotion of prescription drugs, biologics, and/or devices? Does the current regulatory approach and its implementation by industry lead to over-prescription of drugs? Do they increase physician visits or patient compliance with medication regimes? Do they cause patient visits that lead to treatment for under-diagnosed diseases? Does FDA's current approach and its implementation by industry lead to adequate treatment for under-diagnosed diseases? Do they lead to adequate patient understanding of the potential risks associated with use of drugs? Does FDA's current approach and its implementation by industry create any impediments to the ability of doctors to give optimal medical advice or prescribe optimal treatment? The FDA's current approach regarding direct drug advertising has led to prescriptions by consumer demand. Most doctors do not truly understand the drugs that they prescribe - they are beholden to drug company reps and associated perks for promoting specific drugs. Food supplements are grossly under-represented in the current prescriptive paradigm. Until those nutraceuticals with scientifically determined benefits are given medical credence and promotion patients will rarely receive optimal treatment. As it does with drugs, the FDA should grant credability to such nutraceuticals.
3. May FDA distinguish claims concerning conventional foods from those relating to dietary supplements, taking into account limits on claims that can be made about foods in the Nutrition Labeling and Education Act, 21 U.S.C. 301, 321, 337, 343, 371? What must an administrative record contain to sustain or deny claims on food labels? How can information best be presented in a succinct but non-misleading fashion? To what extent do assertions in claims need qualifications or disclaimers added to the label to avoid any misconceptions that consumers may draw? Is there a basis to believe that consumers approach claims about conventional foods and dietary supplements differently? All food and dietary supplement claims promoting specific health benefits should be substantiated by emperical research. If the claims are valid the FDA should not discriminate against foods and dietary supplements by requiring a disclaimer in their advertising. Current FDA practice favors drug approaches over nutritional solutions in all situations. This is wrong and is adversely affecting health.
4. Should disclaimers be required to be in the same (or smaller or larger) size of type and given equal prominence with claims? Is there any relevant authority or social science research on this issue? Disclaimers need to be OBVIOUS. However, FDA disclaimers should only apply to products that make unsubstantiated claims. Substantiated dietary supplement benefits SHOULD NOT be subject to the FDA disclaimer.
6. What arguments or social science evidence, if any, can be used to support distinguishing between claims made in advertisements and those made on labels? Does the First Amendment and the relevant social science evidence afford the Government greater latitude over labels? False advertising claims should be under the perview of the FTC. Product labels should present facts and be true. The appropriate regulatory agency should evaluate for facts and truth without regardless of whether the product is a dietary supplement,drug or food.
8. Do FDA's speech-related regulations advance the public health concerns they are designed to address? Are there other alternative approaches that FDA could pursue to accomplish those objectives with fewer restrictions on speech? Speech that involves claims should be substantiated by science. Possible adverse effects should be noted. Substantiated dietary supplements and foods should be able to make claims without the caveat of the FDA disclaimer.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? The FDA should not discriminate against dietary supplements and foods that provide substantiated specific health benefits. It currently does so by requiring the aforementioned disclaimer.

EC -205