Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -152

Accepted - Volume 4

Comment Record
Commentor Mr. Jerry Lopeman Date/Time 2002-07-17 11:07:52
Organization Mr. Jerry Lopeman
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? In the age of mass communication, the FDA has no right to limit free speech on drugs or dietary supplements. The public is best served by the government getting out of regulating everything. The regulating of drugs and dietary supplements by the FDA has NOT been helpful in providing any better health. In fact, many of the poisons, i.e. drugs, approved by the FDA in the past 10 years, have proved to be very harmful, and subsequently withdrawn from the market. More approved drugs will soon be litigated off the market. The FDA should be abolished. In this day and age, it serves no useful purpose.
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? NONE, and NO.
7. Would permitting speech by manufacturer, distributor, and marketer about off-label uses undermine the act's requirement that new uses must be approved by the FDA? If so, how? If not, why not? What is the extent of FDA's ability to regulate speech concerning off-label uses? What are we paying you for if you have no idea what the extent of your ability to regulate speech of off-label uses is? How can you help anyone if you do not know what your legal authority 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? The FDA has done nothing of value in the last 10 years.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? The FDA should be abolished.

EC -152