Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -166

Accepted - Volume 4

Comment Record
Commentor Mrs. Diane Mueller, RN Date/Time 2002-07-25 12:43:09
Organization Mrs. Diane Mueller, RN
Category Health Professional

Comments for FDA General
5. How can warnings be made most effective in preventing harm while minimizing the chances of consumer confusion or inattention? Is there any evidence as to which types of warnings consumers follow or disregard? Having warnings printed in red ink may be more attention provoking. Having those warnings outlined in a box of red ink may help.
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? I think allowing claims of off-label uses would undermine the act's new uses requirement. Then any manufacturer could make any claims. This could be jeopardizing to someones health condition.
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? I think that the current regulations are adequate and effective. I see no need to make any changes to the regulations at this time.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Again, I commend the FDA for its current practice and I would hope that nothing is changed.

EC -166