Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -45

Accepted - Volume 1

Comment Record
Commentor Mr. Ed Leary Date/Time 2002-05-29 07:11:43
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? Dear Sir/Ms, The First Amendment has been perfectly adequate for regulating speech for centuries. The FDA should not attempt to regulate speech. In a free country, the FDA's mission should be to provide the public with hard facts about products coming onto the market so that a free people can decide for themselves which products to buy. Ed leary

EC -45