Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -428

Accepted - Volume 6

Comment Record
Commentor Ms. judith brody Date/Time 2002-09-15 18:03:41
Organization Ms. judith brody
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? A ban on tobacco advertising, given the known impact of ads on children and teens, should be supported. In effect, tobacco ads are invitations to slow suicide, and as such, should not be allowed.

EC -428