Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -41

Accepted - Volume 1

Comment Record
Commentor Mr. Leo van Olphen Date/Time 2002-05-29 01:13:17
Organization Mr. Leo van Olphen
Category International

Comments for FDA General
6. What arguments or social science evidence, if any, can be used to support distinguishing between claims made in advertisements and those made on labels? Does the First Amendment and the relevant social science evidence afford the Government greater latitude over labels? If a product is proven to be not harmful, no.
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
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? When it is the truth no restrictions on speech
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? If there are scientists making their PhD concerning a substance I think companies must be allowed to use that dissertation for the promotion of their product.

EC -41