Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -420

Accepted - Volume 6

Comment Record
Commentor Ms. Laura Nagel Date/Time 2002-09-13 16:02:04
Organization Drug Enforcement Administration
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? The Drug Enforcement Administration has prepared comments on this notice. The comments are awaiting internal agency approval and will be submitted a soon as possible. Any questions regarding this message or the forthcoming comments may be directed to the Office of Diversion Control at DEA, tel. 202-307-7165.

EC -420