Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -359

Accepted - Volume 6

Comment Record
Commentor Mr. Christopher Lauderdale Date/Time 2002-09-06 23:57:38
Organization Mr. Christopher Lauderdale
Category Health Professional

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? 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. For the FDA, public health should be a higher priority than protecting corporations or their right to advertise. As a nutritionist and educator, I strongly urge the FDA to limit direct-to-consumer language for drugs, alcohol, and tobacco to statements that clearly explain the risks according to currently accepted research findings.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? It has been a clear mistake in interpretation of the first amendment to define corporations as ficticious individuals. Individuals do not have the financial resources to influence others through the media the way corporations do. Therefore, corporations should be held to a more stringent level of responsibility for promoting public health than individuals.

EC -359