Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -416

Accepted - Volume 6

Comment Record
Commentor Mr. Noah Balmer Date/Time 2002-09-13 11:49:04
Organization Mr. Noah Balmer
Category Individual

Comments for FDA General
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? The first amendment should not be looked on as an excuse for pharmaceutical firms to provide misleading information. On the other hand, I think that the most important guidelines the FDA imposes are not the limitations but the requirements. A pharmecuetical company should be required to be as forthright as possible about risks and limitations of their products, and about the possible advantages of other available products. Requiring this type of disclusure does not limit what they say, only requires that they don't defraud people out of their health and money through lies of ommision.

EC -416