Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -361

Accepted - Volume 6

Comment Record
Commentor Dr. Clifton Smith Date/Time 2002-09-07 08:10:33
Organization Baylor College of Medicine
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? The general FDA's position should be that public health takes priority over commercial speech considerations, and the agency should do everything it can to defend its authority to restrict commercial speech in the effort to protect public health. There should be no distinction between drug or dietary promotional speech in this regard, and should be viewed as misleading unless it complies with the FDA requirements.
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? The current regulatory environment appears to be too permission with regard to protection of commercial speech. The promotions lead to over-prescription of drugs.
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 have the same visibility as the claims.
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 based in objective data should be equally visible.




EC -361