Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -379

Accepted - Volume 6

Comment Record
Commentor Dr. Reginald Gibbons Date/Time 2002-09-10 09:48:31
Organization Dr. Reginald Gibbons
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? Commercial or promotional speech has no substantial motive for truth-telling, nor does it represent a *political* or *philosophical* position protected by the first amendment, but on the contrary is essentially advertising, paid for because of its power to raise sales and awareness of a product. For these reasons, speech about drugs, which when issuing from manufacturers or representatives of manufacturers, always aims to create positive reactions to the drugs, is highly compromised in essence and in principle, and cannot logically or philosophically be given the exact same protection as the speech of citizens that is fully protected by the first amendment.
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 required.
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? Consumer confusion might be the desired result of a bad-faith compliance by drug manufacturers, so that they could argue for the position of not being required to issue warnings at all. But surely there are simple ways of giving consumers *some* accurate information disclaiming announced benefits or safety.




EC -379