Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -399

Accepted - Volume 6

Comment Record
Commentor Mrs. Neenah Estrella-Luna Date/Time 2002-09-11 09:51:24
Organization Mrs. Neenah Estrella-Luna
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? All consumables that have a direct impact on the health of individuals and society in general shuld be regulated comprehensively. Advertising is a means to increase demand for a product. Since the physical distribution pharmaceuticals and other drugs are heavily regulated, it makes sense that the marketing that drives its distribution be regulated and monitored as well. It does no good to require a drug be prescribed to be used if advertising encourages people to demand drugs they may not need.
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? Corporations are fictional people created by law. They should not be afforded consitutional rights nor protections in advertising. FDAs current regulations fall far short of protecting the public's health. Direct to consumer advertising of pharmaceuticals does not educate the public anymore than McDonalds advertising of what constitutes a healthy diet. The primary purpose of direct to consumer advertising is to increase sales of a particular drug, often straining the relationship between the physicians responsible for prescribing the drug and the patient demanding it. Physicians must then spend their preciously little time trying to educate patients about the drug and why they may not be a good candidate for it. The FDA would further public health concerns by restricting direct to consumer advertising of pharmaceuticals. Restrictions on advertising directed to children would go a long way towards reducing advertising related diseases like obesity.

EC -399