Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -389

Accepted - Volume 6

Comment Record
Commentor Mr. Kevin Mendenhall Date/Time 2002-09-10 19:58:12
Organization Mr. Kevin Mendenhall
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? Many of the direct-to-consumer advertisments have strongly encouraged people to try new drugs that may not necessarily be for them. This may hinder the doctor's ability to do his or her job as the patient may insist on trying the new drug.
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? Disclaimers should be in at least as large of type as the claims. I personally believe that when something is in larger font, the consumer will pay more attention, or will have no choice but to notice and pay attention.
7. Would permitting speech by manufacturer, distributor, and marketer about off-label uses undermine the act's requirement that new uses must be approved by the FDA? If so, how? If not, why not? What is the extent of FDA's ability to regulate speech concerning off-label uses? The FDA should regulate speech so that the consumers are protected from possibly harmful substances.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? The FDA should not allow companies to advertise for drugs that have not yet been proven safe and/or effective.

EC -389