Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -358

Accepted - Volume 6

Comment Record
Commentor Ms. Christine Clemens Date/Time 2002-09-06 21:21:23
Organization Ms. Christine Clemens
Category Individual

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? Corporations do not have an absolute right to free speech - corporate speech is primarily about advertising and selling. Promotional speech about drugs which is misleading should not be allowed, whether to doctors or ordinary individuals.
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 sells people on the idea that they have a disease for which the best treatment is a particular medication - it is primarily about selling, not educating. I believe there should be far more regulation of direct-to-consumer advertising of drugs, if it is not banned altogether.

EC -358