Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -8

Accepted - Volume 1

Comment Record
Commentor Ms. Melissa Yorks Date/Time 2002-05-28 10:39:03
Organization Ms. Melissa Yorks
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? The problem is not that speech about drugs is over-regulated but that speech about so-called dietary supplements is seriously under-regulated, as is the manufacture and selling of dietary supplements.
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? Direct-to-consumer advertisement leads to over-prescription of the advertised drugs and insistance on use of more expensive advertised drugs over cheaper drugs that work just as well by patients who are swayed by the ads. I seriously doubt that these ads lead to treatment for under-diagnosed diseases. They interfer with the ability of doctors to give optimal treatment by convincing patients that they know better than the doctors.
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? All claims for foods, drugs AND dietary supplements should have records of controlled clinical trials proving the claims and efficacy of the food/drug/supplement. Without them, the ads should be required to state that there is no evidence that the food/drug/supplement works as claimed. This should be at the beginning of the ad, not buried somewhere at the end. If all ads start with the disclaimer that there is no evidence that the product works as claimed in the ad, then I'd agree that regulations by FDA on advertising can be loosened. Otherwise I am oppossed to this proposal to loosen regulations.
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? Yes, and all side effects should be listed in large type.
5. How can warnings be made most effective in preventing harm while minimizing the chances of consumer confusion or inattention? Is there any evidence as to which types of warnings consumers follow or disregard? See no. 3 above. Warnings in small type or hurriedly read at the end of the ad are disregarded.
7. Would permitting speech by manufacturer, distributor, and marketer about off-label uses undermine the act's requirement that new uses must be approved by the FDA? If so, how? If not, why not? What is the extent of FDA's ability to regulate speech concerning off-label uses? Yes- if they are off-label then they haven't been approved.
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? Yes, protecting public health is more important than protecting the pocket books of drug industry executives.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? No.




EC -8