Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -58

Accepted - Volume 1

Comment Record
Commentor Mrs. Carol Merrill Date/Time 2002-05-29 12:04:52
Organization Mrs. Carol Merrill
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? Our First Amendment rights must be protected. The FDA must be responsible to uphold the Constitution of the United States of America.
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? Same size type and let the consumer be the one to decide.
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? You can only give the warning and the individual has the right to choose.
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? No.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Protect the First Amendment, give the evidence, let the consumer do the choosing.




EC -58