Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -330

Accepted - Volume 4

Comment Record
Commentor Mr. Steve Tudisco Date/Time 2002-09-05 13:04:57
Organization Mr. Steve Tudisco
Category Individual

Comments for FDA General
Questions
4. Should disclaimers be required to be in the same (or smaller or larger) size of type and given equal prominence with claims? Is there any relevant authority or social science research on this issue? disclaimers should be the same size and type as claims.
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? warnings should be the same size as claims and should be on the product.
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? 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.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? For the FDA, public health should be a higher priority than protecting corporations or their right to advertise. Restrictions on the advertising of tobacco, alcohol, gambling and pharmaceuticals are essential for protecting public health. Of all the problems facing our country, insufficient advertising of cigarettes, liquor, etc. is not one of them.




EC -330