Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -3

Accepted - Volume 1

Comment Record
Commentor Dr. James Schaller Date/Time 2002-05-20 02:17:03
Organization Chester County Research Center
Category Academic

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 a clinician I feel you kept the best drug in the world--in its class--Moclobemide--out the the USA. It is the safest reversible MAOI anti-depressant. Not everyone responds to all the new Prozac copy-cats. A nutrient and drug should be able to make any claim about anything as long as they explain the basis for the claim. Useful for x based on use in 300 patients who knew they were getting the treatment. The tuning is over my head. The absurd notion that nutrients cannot claim health benefits is stupid 1930's medicine. Do you people read nutrition journals?
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? Leaflets should be provided to patients at MD office and pharmacy which state the risks and benefits and major risks in reasonable 6th grade english--1/30,000 have liver damage...... With crush of HMO's few doctors educate at all. Flying into next room in a fever......
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? If you are so interested in foods and nutrients, test them for the presence of xenoestrogens, misc pesticides, potency falsehoods. Like comsumerlabs.com does. For a fee that is not open to the public.




EC -3