Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -301

Accepted - Volume 4

Comment Record
Commentor Mr. Gene Koprowski Date/Time 2002-08-08 11:21:46
Organization The Institute for Human Rights, Inc.
Category Media

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? Yes. Any fraudulent or misleading advertising should be reigned in immediately. This is done so under Deceptive Business Practices Acts in various states, like Illinois. But the FDA can provide comprehensive protection for consumers nationally if it acts to do the same through the regulatory process.
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? Yes.
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? Yes.
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? Same type face and style.
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? All side effects must be listed. No exceptions.
6. What arguments or social science evidence, if any, can be used to support distinguishing between claims made in advertisements and those made on labels? Does the First Amendment and the relevant social science evidence afford the Government greater latitude over labels? The claims made on labels and adverts should be treated in a like fashion; they influence usage behavior.
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. FDA should approve uses by manufacturers, distributors and marketers -- as well as by those third parties who benefit from the sale of such regulated drugs.
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.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Yes. See Citizen's Petition 02P-0171. Fraudulent and misleading advertising by third parties who benefit from the sales of regulated drugs can and should be regulated. Fraudsters like the National Abortion Federation (NAF) have been running misleading ads about RU-486 -- not telling users what the side effects are. This is deceptive, and harmful to human health. To be sure, there are state laws on the books which regulate such conduct. But they require standing to sue, e.g., the individual who has been harmed must bring suit. The NAF and its allies bash down these claims if the individual cannot prove an ongoing harm -- a high hurdle. Meantime, women are suffering from the side effects of the drug, due to the misleading ads of NAF, and regulatory intervention is required.

EC -301