Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -77

Accepted - Volume 1

Comment Record
Commentor Mr. John Andrade Date/Time 2002-05-30 11:21:52
Organization Mr. John Andrade
Category Individual

Comments for FDA General
7. Would permitting speech by manufacturer, distributor, and marketer about off-label uses undermine the act's requirement that new uses must be approved by the FDA? If so, how? If not, why not? What is the extent of FDA's ability to regulate speech concerning off-label uses? allow people to decide what products they want to take.

EC -77