Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -430

Accepted - Volume 6

Comment Record
Commentor Dr. Seth Kahn Date/Time 2002-09-15 19:00:37
Organization West Chester University
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? The most important argument for regulating drug advertising speech is that people turn to drug companies for life-saving products, and knowing this, drug companies inflate the importance of their products in their advertisements. If drug companies' intentions were actually to save lives, maybe this would be different. But as long as the profit motive is stronger than the motive to protect public health, corporations don't deserve any substantial protections.
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? No. Empirical research shows clearly that consumers respond to advertisements. Companies are allowed to advertise products oftentimes without even announcing what the products do, not to mention how much they cost, not to mention any substantive description of their side-effects, but consumers are pursuing them anyway.
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? The First Amendment shouldn't be an issue here, recent Republican Supreme Court decisions notwithstanding. It's an outrage that the court is protecting advertising as if it were anything other than what it is--generally dishonest, always manipulative.

EC -430