Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -6

Accepted - Volume 1

Comment Record
Commentor Dr. Steven Zeitzew Date/Time 2002-05-23 18:31:16
Organization Veterans Administration
Category Health Professional

Comments for FDA General
Questions
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? A great deal of harm and confusion comes from having several different standards for what common sense tells us are indistinguishable products. In the drug store, packages of pills liquids and powders have completely different standards of regulation regarding efficacy, safety, circumstances under which they can be sold and claims that are made about them and these standards are based on the artificial categorization as drugs, supplements, homeopathics, or compounded drugs. There is no logical reason to have multiple sets of rules and standards. In fact, the fact that a supplement or homeopathic can be packaged and marketed in a way indistinguishable from other drugs misleads consumers into thinking that they meet the same FDA standards for safety, efficacy, and purity as apparently identical but actually FDA approved OTC and prescription drugs. My opinion is that we should have one uniform standard for purity, safety, efficacy, marketing, label claims, and so forth. The standard should be based on scientific evidence and truthfulness. The burden of that proof should be on the manufacturer not on the consumer.
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? Our standard for advertising claims should be truthfulness as shown by scientific evidence. Anything less is misleading and fraudulent. It is not harmful to advertise legitimate products honestly; it is the equivalent of fraud and theft to allow unsubstantiated claims on labels and in advertisements. We should abandon the current practice of allowing supplements compounded medications and homeopathics to make unsubstantiated claims and hold them to the same standard as other pharmaceuticals.
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? Dietary supplements are not foods; they look and act like pharmaceuticals and should be held to that standard.




EC -6