Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -385

Accepted - Volume 6

Comment Record
Commentor Mr. Thomas O'Keefe Date/Time 2002-09-10 16:47:24
Organization The Oker Institute
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? Speech about drugs must be regulated more stringently than that about dietary supplements because the effects of many of the latest drugs (particularly the SSRIs) on behavior and their habituative nature are more significant to an individual's physical and fiscal health.
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? No. Industry's DTC advertising has resulted in numerous instances of patients demanding specific drugs, without any comprehension of their actual utility or even proper area of application. Ads cite very vague and common symptoms, and announce that XYZ will help. This promotes a cultural viewpoint that drugs will solve anything and fosters a context in which adolescent drug use (legal or not) is almost unavoidable.
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 be in as large a type face as any claims. Having worked (in college) as a graphics professional, I received a large amount of training in font-size, color choices and layout locations to maximize or minimize portions of the message. This stuff is ad industry standard.
7. Would permitting speech by manufacturer, distributor, and marketer about off-label uses undermine the act's requirement that new uses must be approved by the FDA? If so, how? If not, why not? What is the extent of FDA's ability to regulate speech concerning off-label uses? Yes. If off label use is regulated by the FDA, then speech about it must also be regulated. The underlying assumption among almost all lsteners is, they couldn't say that unless the FDA had approved it.

EC -385