Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -311

Accepted - Volume 4

Comment Record
Commentor Dr. Kirk Anderson Date/Time 2002-09-04 21:29:50
Organization Wheaton College
Category Academic

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? All advertising about any product whatsoever is inherently misleading, so the answer to that question is yes. Speech made to learned intermediaries may be made in the interest of informing, whereas speech made to consumers is always in the interest of promotion. As evidentiary basis, we have only to look at the discourse of direct-to-consumer advertisements for prescription drugs and compare it to information for the same products that is distributed to doctors.
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? FDA's current approach is already far too favorable to the pharmaceutical industry. In a much wiser age, not all that long ago, prescription drugs were not advertised to the public. There was a sound reason for this prohibition and there still is.
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? Yes, but insufficiently. No, there are no alternative approaches unless the FDA finds a way to outspend the pharmaceutical industry.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Either drugs require the expertise of a medical doctor, or they don't. In the latter case, then they should be available over the counter. In the former case, what we have, in the case of direct-to-consumer advertising, is a blatant undermining of the physician's authority and a travesty of the first amendment. If one recalls that your mission is to the public, then these questions are not nearly so complex as they seem.

EC -311