Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -113

Accepted - Volume 2

Comment Record
Commentor Mr. James Dombrowski Date/Time 2002-06-05 09:10:11
Organization Individual
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? I believe that the FDA's proposal goes against our first amendment right to free speach. I do not believe that the FDA as a government agency has the right to dictate what a drug or suppliment supplier may say in promoting their product. If a drug company is making false clames, this should be inforced by the Federal Trade commission, as in any false advertising.
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? No comment on this issue.
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? No comment.
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? Disclaimers should be ledgeable, the size of the font should be up to the vendor.
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? I do not believe the FDA's speech-releated regulations advance the public health concerns they are designed to address. An alternative would be to allow FDA approved drugs and suppliments to carry such a lable and educate the public as to what that means. This would be similar to the UL label for comsumer products.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Yes, the FDA has been too restrictive of Doctors and Health practictioners freedoms to practice medicine as they see fit. The sould focus on prventing lying and cheating, but not dictate types of treatments or how to practice medicine. Shutting down health clinics and such because they do not agree with there practices is to create a police state.

EC -113