Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -65

Accepted - Volume 1

Comment Record
Commentor Mr. Alan Jenkin Date/Time 2002-05-29 15:58:46
Organization Mr. Alan Jenkin
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? (a) Yes (b) ? (c) Don't know (d) Yes -- presumably a speech made to learned intermediaries should be less subject to misinterpretation, provided that the information given is complete and accurate. (e) Don't know
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? (a) No (b) Current practice leads to expensive, sometimes innefictive and occasionally dangerous treatments which generally attempt to control symptoms rather than remove the cause of the problem. (c) Yes (d) Yes (e) Yes (f) No (g) No (h) Yes -- doctors do not generally have the time to do their own research, so they rely on sales pitches for FDA-approved drugs
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? (a) Yes (b) Claims on food labels must be supported by data from INDEPENDENT studies, not studies sponsored by the manufacturer or a trade association. (c) There is no short answer to this question. (d) Same comment (e) Yes. Nutritionally-educated consumers are aware that most food claims are misleading, at leat to the extent that they are applied to processed foods.
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? (a) Yes (b) Don't know

EC -65