Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -354

Accepted - Volume 6

Comment Record
Commentor Mr. John Lindhe Date/Time 2002-09-06 15:11:53
Organization Mr. John Lindhe
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? Since the FDA is looking at speech in the form of commercials that look at public health, they should be able to restrict ads that mislead (for example do not compare their drug to cheaper generic brands or downplay side effects) and/or encourage activities known to be detrimental (such as smoking). To bypass such restrictions, ads should have to show that they are informative.
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 companies have good reasons to try to increase use of a given drug, this will (at times) have ill effects such as increasing the likelihood of overprescribing or using more expensive but not better drugs. They can also be used to inform the public of new and better treatments and to better inform the public about possible conditions that they might have. There is a line between the right to inform the public and the attempt to increase sales. If the direct to consumer advertising is informative then it should not be restricted, but again if it is misleading it must be.
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? It should be enough for the FDA or other federal agencies to show that commercial speech restrictions reasonably work to directly advance legitimate governmental goals. There are almost always alternatives with fewer restrictions, but if these are difficult or impossible to achieve then they are not real alternatives.
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.

EC -354