Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -407

Accepted - Volume 6

Comment Record
Commentor Mr. Fritz Herrick Date/Time 2002-09-11 18:00:51
Organization Mr. Fritz Herrick
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 - Certain promotional speech about drugs is inherently misleading unless it complies with FDA requirements. The drug manufactures are currently more concerned with profits than public health, and it is the FDA's job to keep the drug companies from acting on their profit at any price attitude.
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? While it is vital that consumers be empowered with information about pharmaceuticals, DTC ads are about promotion, not education.
8. Do FDA's speech-related regulations advance the public health concerns they are designed to address? Are there other alternative approaches that FDA could pursue to accomplish those objectives with fewer restrictions on speech? The FDA should attempt to restrict the speech of pharm. corporations at every opportunity.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? The FDA's position should be that public health takes priority over commercial speech considerations, and the agency should do everything it can to defend its authority to restrict commercial speech in the effort to protect public health.




EC -407