Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -335

Accepted - Volume 4

Comment Record
Commentor Dr. peter buckley Date/Time 2002-09-05 14:25:46
Organization Center for Ecoliteracy
Category Other

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? broad based consumer advertising is always, by its nature, a biased, incomplete communication. Yes, it should be regulated
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 advertising exists only to increase sales of drugs, not to increase health. The emotional power of advertising will always submerge any rational disclaimers, facts, etc to the detriment of public health.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? My main comment is that Commercial speech is in no form analogous to personal rights to free speech. The history of Corporate Commercial Speech should be evidence enough of deleterious effects on public health.

EC -335