Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -336

Accepted - Volume 4

Comment Record
Commentor Mr. Joshua Stearns Date/Time 2002-09-05 14:52:14
Organization Mr. Joshua Stearns
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? When corporations enjoy First Amendment protections it essentially nullifies the speech rights of individuals, since individuals cannot afford the massive advertising campaigns that corporations wage, and so cannot talk back.
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? Restrictions on the advertising of tobacco, alcohol, gambling and pharmaceuticals are essential for protecting public health. Of all the problems facing our country, insufficient advertising of cigarettes, liquor, etc. is not one of them. * Corporations use advertising to drive a wedge between parents and children, and seduce children to nag for junk food and other items that many parents oppose. * Children are especially vulnerable to advertising, because corporations use sophisticated psychological techniques to trick them, and because children lack the maturity to deal with these techniques. * Due largely to the assault of marketing to children, there have been marked increases in marketing-related diseases, such as childhood obesity and type 2 diabetes.
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? For the FDA, public health should be a higher priority than protecting corporations or their right to advertise. * Corporations are far too powerful already. The FDA should seek the right balance between individuals and corporations in the arena of public health, and not tip it further towards corporations and their lobbyists in our nation's capital.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? * Although the FDA does not currently have jurisdiction over tobacco, there are many proposals to give it such jurisdiction. If the FDA gains jurisdiction over tobacco, but has little power to regulate advertising, it would not be able to protect public health from the tobacco companies. Advertising of tobacco should be illegal in the United States.

EC -336