Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -362

Accepted - Volume 6

Comment Record
Commentor Mr. Jim Klosterman Date/Time 2002-09-07 14:18:24
Organization Mr. Jim Klosterman
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? * The FDA's position should be that public health takes priority over commercial speech considerations, and the agency should do everything it can to defend its authority to restrict commercial speech in the effort to protect public health.




EC -362