Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -321

Accepted - Volume 4

Comment Record
Commentor Dr. Felicia Lewis Date/Time 2002-09-05 08:47:43
Organization Dr. Felicia Lewis
Category Health Professional

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? I think the negative effects of direct-to-consumer advertising outweigh the positive. In my personal experience, these ads make patients want specific drugs that may not be the best ones for them and which most assuredly are not the cheapest drugs (hence the advertising-- they never advertise old, cheap drugs). This can make the interaction of doctors and patients more combative and erode trust, for example if the doctor does not wish to prescribe the drug that the patient has seen on television. In addition, the pharmaceutical industry spends around $15 billion in advertising, money that could well be better used in research or in keeping reasonable prices on medications. They already have the highest profit margins of any industry, built on the shoulders of sick people.
4. Should disclaimers be required to be in the same (or smaller or larger) size of type and given equal prominence with claims? Is there any relevant authority or social science research on this issue? I feel disclaimers should have to be thorough and in the same size of type. This would echo the interaction that a doctor would have with a patient; a full and detailed discussion of the risks and benefits of taking such a medication.

EC -321