Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -353

Accepted - Volume 6

Comment Record
Commentor Ms. Katie McCarthy Date/Time 2002-09-06 14:45:21
Organization Ms. Katie McCarthy
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? There are numerous negative affects of DTC advertisements. The drugs and devises being advertised are not the safest nor the best alternative for consumers, they are often more expensive than generic alternatives, they don't give useful information such as success rates or fully explain the potential side effects and evidence has shown that these ads needlessly increase the demand for these drugs and devices even though they may not be necessary for the individual. Evidence also indicates that doctors are influenced by these advertisements and may be prescribing the drugs needlessly.
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 definitely be just as legible (i.e. in the same font type and size) as the claims. Consumers deserve full information without having to hunt it down.
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? The FDA's current self-restraint policy is not sufficent. The FDA should preview DTC ads in order to prevent misinformations and DTC advertisers should be required to run corrective ads after receiving FDA warning letters.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? The FDA's position should be that public health takes priority over commercial speech considerations, and the agency should do everything it can to defend its authority to restrict commercial speech in the effort to protect public health. According to the courts, commercial speach is protected when it provides information to the public. It is therefore the responsibility of the FDA to determine the difference between educational validity and purely promotional advertising.

EC -353