Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -94

Accepted - Volume 2

Comment Record
Commentor Mr. Robert Friedlander Date/Time 2002-06-01 08:21:32
Organization Mr. Robert Friedlander
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? Drugs have more of a potential to cause harm or death. As a consumer, I would exercise more caution before using a drug than a supplement. The FDA does not determine what is misleading. Its strength is in the evaluation of products. Certainly, a communication must consider its audience. You would not talk to a two-year-old in the same manner as you would an adult.
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? These are important questions which require a study of the research. Helful also would be a statement of the FDA's current position. Where can I find one?
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? I am not sure that disclaimers should be required, but if they are to appear, then it should be in the same size of type as the claim, neither larger nor smaller.
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? Warnings are best understood upon examination of the research upon which they are based. A referral to such research would be helpful. Without such research, one would require faith in the disseminator. The FDA inspires no such faith, but its disclaimer may misleadingly frighten uninformed or naive consumers.
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? I see no difference. Labels are, to a great extent, advertising.
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? Possibly, but if a product has been evaluated and approved for certain uses only, then a statement to that effect should be available before purchase, i.e. appear prominently. Free speech should not be interfered with.
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? No. The stength of the FDA is in its scientific research and the dissemination of same. Any involvement with issues of regulating speech detract from its mission.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Eliminate the warning This product has not been evaluated by the FDA. A product should either be evaluated or not.P




EC -94