Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -174

Accepted - Volume 4

Comment Record
Commentor Mrs. Charla Cupit Date/Time 2002-07-25 15:44:06
Organization Mrs. Charla Cupit
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? Yes, I believe drugs should definitely be more regulated than dietary supplements.
2. Is FDA's current position regarding direct-to-consumer and other advertisements consistent with empirical research on the effects of those advertisements, as well as with relevant legal authority? What are the positive and negative effects, if any, of industry's promotion of prescription drugs, biologics, and/or devices? Does the current regulatory approach and its implementation by industry lead to over-prescription of drugs? Do they increase physician visits or patient compliance with medication regimes? Do they cause patient visits that lead to treatment for under-diagnosed diseases? Does FDA's current approach and its implementation by industry lead to adequate treatment for under-diagnosed diseases? Do they lead to adequate patient understanding of the potential risks associated with use of drugs? Does FDA's current approach and its implementation by industry create any impediments to the ability of doctors to give optimal medical advice or prescribe optimal treatment? The industry's promotion of prescription drugs or devices is not in the best interest of the people. They should be allowed to have a say in which drugs they get for a particular ailment. If the current law is changed, there will be little option for the common man to make his own decisions about alternative health care.




EC -174