Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -150

Accepted - Volume 2

Comment Record
Commentor Ms. Jane Greene Date/Time 2002-07-13 21:03:56
Organization Ms. Jane Greene
Category Health Professional

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? In my humble estimation, the FDA does not possess the right to curb the first Amendment, as can be seen by even a casual reading of said language! However, I am not so naive as to believe it (the FDA) would not do so, the amendment notwithstanding. The FDA has the responsibility to protect the public from being harmed by various substances, of course; but, to the best of my knowledge and belief, there has never been a death caused by the use of vitamins and minerals. So why must there be such a plethora of regulation of claims by the FDA of these substances? Is it really necessary?
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? From what I have been able to discern, no, they do not advance the public health concerns they are designed to address AS RELATED TO VITAMIN/MINERAL SUPPLEMENTATION.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Please see the comments supra. Thank you very much for your time.

EC -150