Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -145

Accepted - Volume 2

Comment Record
Commentor Dr. Andy Aligne Date/Time 2002-07-05 09:27:39
Organization Dr. Andy Aligne
Category Health Professional

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? Yes. as a phsyician with expertise in clinical epidemiology, it is obvious that the direct to consumer ads are extremely misleading to the average layperson, and of course they are always misleading in hte direction of sellign the product. the cholesterol lowering drugs, e.g. claim that millions of people need treatment, implying that all those people will die prematurrely without those meds, but the tiny unread print says that these drugs have not been shown to reduce mortality from heart attacks.
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? in order to perform any sort of useful public health purpose, the drug ads would need to be limited to straighforward presentation of well-proven benefits and risks, without other promotional dramatic motivational psychology advertising nonsense.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? this is not a First Amendment issue. the drug companies are saying inherently misleading nonsense over and over again (allegra is the only drug that contains allegra!) in order to sell as many units as possible of the most expensive types of pills. they are basically practicing medicine without a license shilling their patent remedies to patients in inappropriate ways, trying to convince people to take things they don't need and that might harm them. this is unethical, irresponsible behavior that is bad for the health of the public. speech that endangers the public and is otherwise of no redeeming social value is not protected by the first amendment.

EC -145