Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -14

Accepted - Volume 1

Comment Record
Commentor Dr. Garrett Lear Date/Time 2002-05-28 20:11:16
Organization Well Of Living Water Christian Fellowship
Category Association

Comments for FDA General
Questions
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? freedom of speech has no differentiation between print,oral or any other means. Caveat Emptor
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? Freedom for the PDR and any publications that inform the consumer
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? No...Yes....keep the drug salespeople from being the doctors' main source of information about any pharmaceutical.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Yes...be more sensitive to good science and experience rather than commercial lobbyists




EC -14