Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -367

Accepted - Volume 6

Comment Record
Commentor Dr. Ray Pfeiffer Date/Time 2002-09-09 11:29:43
Organization Dr. Ray Pfeiffer
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? I think it is very unfortunate that drug companies have begun marketing prescription-only drugs directly to consumers. These advertisements are highly misleading because they cannot by their nature target individuals and their particular medical situations as is appropriately done at the doctor-patient level. So I believe that there are strong arguments for severely restricting the ability of drug companies to market directly to consumers.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? The first amendment SHOULD NOT be extended to cover speech made by corporations. While common law appears to have been slowly creeping toward extending such rights to corporations, corporations are not human beings, and should not be afforded the same rights. Moreover, there is an inherent unfairness in affording corporations first amendment rights, because their economic power, and hence the strength of their message, is disproportionate to non-corporate citizens.

EC -367