Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -346

Accepted - Volume 6

Comment Record
Commentor Mr. Robert Cote Date/Time 2002-09-06 10:38:52
Organization Mr. Robert Cote
Category Individual

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? Because corporations should not have any constitutional protections, and because commercial speech should not receive constitutional protection, the FDA should press as hard as possible against existing limitations in these areas.




EC -346