Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -133

Accepted - Volume 2

Comment Record
Commentor Dr. Edward Leary Date/Time 2002-06-18 06:11:54
Organization Future Technologies
Category Company

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? The Qusestion is: When does the FDA's responsibility to protect the public against harmful consumables violate the First Amendment of the Constitution? Unless the FDA can show with undisputable scientific evidence that a consumable is, or is not, harmful, then the FDA has violated the First Amendment.

EC -133