Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -108

Accepted - Volume 2

Comment Record
Commentor Mr. Bruce Huron Date/Time 2002-06-03 17:42:01
Organization Mr. Bruce Huron
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? Consumers are, or may be, learned intermediaries. Consequently, an attempt to limit speech based upon arbitrary qualities of the supposed reader is senseless, and cannot be shown to serve the good of the public.
6. What arguments or social science evidence, if any, can be used to support distinguishing between claims made in advertisements and those made on labels? Does the First Amendment and the relevant social science evidence afford the Government greater latitude over labels? This issue can be addressed by requiring claims made in advertisements to be preceded by: IN THE OPINION OF_______ where the blank is filled by the name of originating source. Attempting to limit speech content is not allowed.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Of the people, by the people, for the people This is the basis for governance. There is no good that comes from attempting to save the people from themselves, in violation of The Constitution.

EC -108