Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -372

Accepted - Volume 6

Comment Record
Commentor Mr. R. Neal Bell Date/Time 2002-09-09 15:57:36
Organization Mr. R. Neal Bell
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? As an individual who is not a lawyer, I find this question a bit intimidating. I think rather than draw distinctions between different KINDS of drugs (i.e. OTC drugs versus dietary supplements, versus D-T-C drug advertising), I believe that the FDA should focus on the basic issue of public health. More specifically, public health should take priority over commercial speech considerations. If the FDA feels that a given drug (and the way it is being marketed) poses public health issues that are not properly addressed by said marketing, the FDA should have the authority to curtail the way that that drug is portrayed by corporate commercial marketers.
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? While it is vital that consumers be empowered with information about pharmaceuticals, DTC ads are about promotion, NOT education. Many DTC ads understate safety risks (in hushed tones at the end of TV commercials, or in the fine print of magazine ads), which is likely to lead to increased consumer demand by large groups of citizens who are not real candidates for the drug. DTC ads also encourage higher consumption of higher cost brand-name products in place of less expensive generics (leading to fundamental problems of affordability for our citizens). At a minimum, I think that these corporate DTC ads should be leavened by having the FDA post non-biased information regarding all of these drugs on their website and through printed materials - and this should be required to be made know in each DTC ad.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? While the FDA does not currently have jurisdiction over tobacco, there are numerous initiatives to give the agency such jurisdiction -- including some legislative proposals favored by the tobacco industry - and good reason to expect Congress will confer jurisdiction in the near future. As such, FDA should consider the issue of tobacco advertising in determining its posture on overall commercial speech issues.

EC -372