Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -392

Accepted - Volume 6

Comment Record
Commentor Mr. Deitrich Zook Date/Time 2002-09-10 23:34:00
Organization Mr. Deitrich Zook
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? The FDA can certainly sustain a position that certain speech about drugs is inherently misleading! Products should be able to say what they are meant for but misleading information should be banned.
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? Advertisements for drugs promote a dependence on those drugs that is often not necessary. Doctors are there to help and indeed prescribe certain drugs when needed. It is not something that should be promoted with ads.
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? First traditional foods are a necessity for life. They contain calories which are essential. We know when traditional foods are not working; we get hungry. But, we have no way to know, from our bodies alone, if supplements are working. Furthermore, the claims made by supplement makers make it seem as though the supplements are super foods better than any other food. When in fact those supplements are not essential for life. Also, there is often a dramatic price differance between supplemental foods and traditional foods.
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? The FDA could require groups of companies in a particular business to publish a web site or booklett that would point out the negative affects of those products.

EC -392