Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -165

Accepted - Volume 4

Comment Record
Commentor Mr. Steven Keller Date/Time 2002-07-25 12:41:05
Organization Mr. Steven Keller
Category Individual

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? As long as the substance is non toxic it should be up to the consumer to properly educate themsleves, and the FDA should remove all barrienrs to such education.
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? I think the direct to consumer advertising of prescriptions is out of control and puts pressure on MD's to overprescribe potnetially harmful .
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? The FDA needs a simple and cost effective system of trials to determine wether there is efficacy in a substance. It should be radically easier and less expensive than the protocol for testing toxic .
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Again if a simple initial trial has been donne showing a products effectiveness there should be no restriction in sharinfg this information.




EC -165