Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -307

Accepted - Volume 4

Comment Record
Commentor Mr. Todd Bearson Date/Time 2002-09-04 20:14:11
Organization Mr. Todd Bearson
Category Individual

Comments for FDA General
1. Are there arguments for regulating speech about drugs more comprehensively than, for example, about dietary supplements? What must an administrative record contain to sustain such a position? In particular, could FDA sustain a position that certain promotional speech about drugs is inherently misleading, unless it complies with FDA requirements? Does anything turn on whether the speech is made to learned intermediaries or to consumers? What is the evidentiary basis of such a distinction? While commercial speech may or may not be a protected form of speech under the first amendment, it is counter to the FDA's role in protecting the public from fraudulent claims or misleading advertising. The question of who gains by this decision should be weighed carefully. As it stands, the very consumers the FDA is mandated to protect will be at the mercy of those truly benefit from the rule.
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. Is there any relevant or social science on the original 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? Direct language is the best method

EC -307