Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -316

Accepted - Volume 4

Comment Record
Commentor Mr. Charles Davis Date/Time 2002-09-05 00:52:01
Organization Mr. Charles Davis
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? Drug advertising focuses mainly on selling a drug rather than education. This can have the dangerous repercussion of the overprescription of drugs. It has been seen that patients will insist on a particular name-brand drug based on an advertisement he or she has seen, despite the fact a doctor suggests another brand of drug or no drug at all. Anti-depressents are a case in point where the drug is dangerously overprescribed. This is a case where drug advertising has casued people to value a corporate image over what is best for their bodies. An administrative body must be able and willing to curb advertising run amok by closely studying advertisements and determining what the consumers will learn from it. Public awareness of drugs is certainly a good thing but this is completely different from advertising that entices people to use a drug they may not even need. The FDA must regulate such matters since it is capable of maintaining a higher moral standard than a pharmacuetical company. I don't mean to say pharmceutical companies are evil by nature, but as long as they are in the business of selling pills, they will seek to sell as many pills as possible. Sometimes morality can be lost in the shuffle.
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? Speech-related regulation do indeed advance public health concerns. In fact, they are a necessity to protect consumers. No company will actively pursue a stance of advertising its products' dangerous effects. This is in direct contradiction with the profit motive. A third-party such as the FDA, which does not suffer from the profit-motive moral delimiter, is free to make decisions in the public interest.

EC -316