Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -334

Accepted - Volume 4

Comment Record
Commentor Mr. Wayne Rannelli Date/Time 2002-09-05 13:30:12
Organization citizens of the U.S.A.
Category Individual

Comments for FDA General
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 effect of direct-to-consumer advertising has cast a pall on already existing health-care inadequacies. The fact that Corporations are hiding behind the First Ammendement and Free Speech protections in order to sometimes directly lie and misrepresent a product is shameful and further proof that the Federal Government must do more, not less to regulate business. For instance a highly dangerous and addictive medicine paroxetine (Paxil) is advertised as being non-addictive which is in direct conflict with what is known about this product.
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's speech-related regulations do not advance the public interest in that they give corporations who are foremost involved in profits to much leeway to make claims that are inappropriate and untrue, and to not provide balanced usable data for the targetted consumer.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? We must look strongly at re-regulation of pharmaceutical direct-to-consumer advertising. Now millions of better appropriated health-care dollars are used to batter us with advertisements for medicines we don't need. Rather than the prescribing of medicine based on a process that includes recognizing symptons and a diagnosis by a liscensed physician, we are bombarded with advertisements that tell us to pursue medicines for purposes we know not. Regulation and 1st Ammendment Free Speech issues must not be mixed so as to weaken both.

EC -334