Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -435

Accepted - Volume 6

Comment Record
Commentor Mr. Austin Paulnack Date/Time 2002-09-17 14:53:21
Organization The Accountability Project
Category Other

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 wholeheartedly agree with Public Citizen that consumers need more safeguards from misleading drug advertising and that the FDA should better protect our health by tighter regulations on ads for drugs, vitamins, dieting, tobacco and alcohol.

EC -435