Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -318

Accepted - Volume 4

Comment Record
Commentor Dr. J.D. Walker Date/Time 2002-09-05 08:12:31
Organization Dr. J.D. Walker
Category Academic

Comments for FDA General
Questions
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 are very good reasons to regulate speech about drugs rather strictly. Health care costs in the US have been rising at unsustainable double-digit rates for the past several years, with the cost of drugs rising fastest of all. Several factors contribute to this problem, one being the direct marketing of drugs to consumers. Free-market solutions fail when it comes to pharmaceuticals because consumers are insufficiently knowledgeable to make utility-maximizing choices about drugs. All direct-to-consumer advertising of drugs should be prohibited, though advertising to health care professionals need not be.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? In general I believe that the FDA should retain, and indeed strive to strengthen, its authority to regulate commercial speech. Traditionally, commercial speech has not been granted the same level of First Amendment protection granted to other sorts of speech. There are good reasons for this: commercial speech does not have the sort of value possessed by, for instance, political speech, and should be permitted only to the degree that it promotes the public interest.




EC -318