Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -137

Accepted - Volume 2

Comment Record
Commentor Mr. Mettitt R. Wright Date/Time 2002-06-19 14:01:47
Organization Mr. Mettitt R. Wright
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? FDA should stop considering themselves a law unto themselves and obey the law for a change. Your goal is to protect people NOT BIG DRUG COMPANIES/
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? Most prescription drugs come close to falling into the poison category. They have so many side effects they can kill the unsuspecting. You and the drug companies do all in your power to intimidate any doctors wise enough to see the value in supplements

EC -137