Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -86

Accepted - Volume 2

Comment Record
Commentor Mrs. Margaret Dulmage Date/Time 2002-05-31 14:22:36
Organization none
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? None legally since this country is established on the basis of free speech. It is the listeners responsibility and right to choose to believe or not to believe, not our government's.
8. Do FDA's speech-related regulations advance the public health concerns they are designed to address? Are there other alternative approaches that FDA could pursue to accomplish those objectives with fewer restrictions on speech? That is irrelevant - whether there is or isn't - free speech is guaranteed by our constitution. We have the right to accept or disregard information we hear.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Yes - I see your job as making sure labels represent all the ingredients in the container.

EC -86