Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -386

Accepted - Volume 6

Comment Record
Commentor Mr. Edward Kadane Date/Time 2002-09-10 17:41:36
Organization ACME CD Mfg.
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? Yes, they should. I don't know that research is necessary.
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? Informing of side-effects is best. People pay attention to those sorts of things.
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? Restricting commercial speech seems to be the only way to go.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Corporations and commercial speech should have no constitutional protection. They do under existing court decisions and the appropriate response of the FDA is to push as hard as possible against the limits of these misguided constitutional protections. Overly broad commercial speech protections will inappropriately transform legislative or regulatory decisions about public health issues into constitutional issues. (This is an argument Justice Breyer made in dissent in Western States Medical Center.)




EC -386