Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -329

Accepted - Volume 4

Comment Record
Commentor Dr. Douglas Greve Date/Time 2002-09-05 12:59:23
Organization Dr. Douglas Greve
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? The argument is that some substances are more harmful or risky than others, and the more harmful ones should be regulated more closely. Promotional speech to learned intermediaries should not be treated differently than that directed to consumers.
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? The main benefit of direct-to-consumer marketing is that is may lead to treatment for under-diagnosed diseases. More than likely, however, it will lead to consumers trying to diagnose themselves based soley on information from an entity interested only in their wallet. The doctor, as the only informed advocate for the patient's health, is cut out of the loop.
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 required to be in the same size of type and given equal prominence with claims.
6. What arguments or social science evidence, if any, can be used to support distinguishing between claims made in advertisements and those made on labels? Does the First Amendment and the relevant social science evidence afford the Government greater latitude over labels? There should be no distinction between the claims made on an advertisement and those made on a label.
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? Allowing manufactures, etc, to make claims about untested uses of a drug would strongly undermine the act's intent. It would encourage people to fake the symptoms for the approved use in order to obtain medication to realize an unsubstantiated effect.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? For the FDA, public health should be a higher priority than protecting corporations or their right to advertise.

EC -329