Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -184

Accepted - Volume 4

Comment Record
Commentor Mr. Glen TeVault Date/Time 2002-07-25 17:13:02
Organization Mr. Glen TeVault
Category Health Professional

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? As I read your question, three thought come to mind: As good as some regulation of speech may seem,compliance with the First Amendment is first and foremost. The constitution and amendments are the foundation and core for over 225 years. What authority does the FDA have to control or regulate speech. The FDA is doing a good job, for the most part, of testing drugs and assuring safe products are approved for market. This is where your focus should be, and authority limited thereto. Althogh I can't see a legal reason to bypass the First Amendment, if there should need to regulate adverting and labels, the FTC would fit that roll more logicly than the FDA.
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? As previously stated, the FDA should not be concerning itself with advertising nor empirical research on the effect of those advertisements The responsibility fall directly on the medical practitioners, as well as the AMA to assure that there is no abuse of drugs approved by the FDA for market. Doctors that abuse there responsibility need a visit from the FDA. FDA monitoring of health professions actions is critical.
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? As stated above, I don't believe this question should concern you. From my research, there is far less harm from dietary supplements than pharmacutical companies would like you to think.
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? I have already spoken on this issue as well as the rest of the questions.

EC -184