Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -116

Accepted - Volume 2

Comment Record
Commentor Dr. Joan Friedland Date/Time 2002-06-05 11:27:57
Organization None
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? AS a cancer survivor I believe that Drug companies have too much freedom to promote drugs that cost more and may not be as safe as older drugs. I believe that public safety demands that the FDA have the authority to regulate speech re: prescription drugs. In general the drugs have more toxic effects than most dietary supplements and the public is better served if the FDA can regulate this type of speech.
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? Positive effects are that the public is aware of the existence of some drugs. Negative effects are that patients ask for new drugs that are being promoted and may not be any better than the older genetric drugs that they are attemping to replace. THis raises astronomically the cost of prescription drugs. They also lead the public to believe that everything can be cured by medication where often better nutrition and exercise can often substitute for very expensive medications. The result has been that the price of prescription drugs has risen much faster than the general rate of inflation and many public as well as private insurance companies are going broke or cutting back dramatically their prescription coverage. Many seniors have to choose between eating and their prescription medication and the public if often not well served.

EC -116