Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -314

Accepted - Volume 4

Comment Record
Commentor Mr. Roy Evritt Date/Time 2002-09-05 00:32:42
Organization Mr. Roy Evritt
Category Individual

Comments for FDA General
Questions
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? Medications have an inherent potential for abuse or misuse. Allowing a corporate PR firm (formerly known as propaganda)to engineer perceptions about drugs among relatively less educated citizens serves no legitimate medical purpose. The clinitian needs a free judgment, unfettered by the demands of brain-washed clients.
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 as prominent as the largest type and have equal prominence.
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? One can write warnings in plain english. Warnings should include the number of subjects reporting a complication compared to the number in the entire study.
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? Yes. Once an off-label use comes to a distributor's attention, the distributor has a financial stake in promoting that use. The FDA should have complete control over advertising off-label uses.




EC -314