Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -370

Accepted - Volume 6

Comment Record
Commentor Mr. Lawrence Grasso Date/Time 2002-09-09 14:06:56
Organization Mr. Lawrence Grasso
Category Academic

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? I believe there is an inherent public health interest in regulating speech about drugs, dietary supplements, and all commercial products. Speech to general consumers, especially in the form of 30 - 60 second advertising spots on radio and TV are inherently more misleading than speech directed at learned intermediaries.
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? I think there is ample evidence that direct-to-consumer advertisements lead to over-prescription and over-use of brand name products as opposed to generic products. I beleive physicians feel pressured to placate their patients as long as they believe the requested treatment is not harmful and it may be as or nearly as effective as a lower cost regimen.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? I believe the FDA has a compelling need and right to regulate commercial speech. In light of Supreme Court rulings which I believe allow unwarranted protection to commercial speech, the FDA must should seek more evidence supporting the efficacy of speech restrictions.

EC -370