Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -104

Accepted - Volume 2

Comment Record
Commentor Ms. Sharrhan Williamson Date/Time 2002-06-02 17:29:21
Organization Ms. Sharrhan Williamson
Category Individual

Comments for FDA General
Questions
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 FDA's emphasis on regulating speech about supplements while allowing free speech to drug companies based on what so often turns out to be dangerously flawed or even blatantly misleading research is disheartening. These drugs are rushed to market and glibly pushed on unsuspecting, uneducated consumers by doctors who are bribed by the drug companies with gifts and perks. Often people are not made aware of side effects and are subject to secondary disease conditions are a result of the drug, thus requiring more drugs. It is apparent that the pharmaceutical industry has the FDA, the medicla journals and the medical schools in its hip pocket, and it's time for the FDA to take a hard look at this and admit that corruption in research and marketing of dangerous and unnecessary, (not to mention expensive) drugs is a scandal that needs to be addressed, rather than concentrating on penalizing and stifling the free speech rights of the supplement companies.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? The FDA is unnecessarily hard on manufacturers of herbs and supplements, to the point of persecution, taking every opportunity to vilify and punish them harshly when accidents or problems occur. Yet when even worse events happen as a result of allopathic drugs, the FDA is rarely punitive, is very slow to take action (even when deaths are involved) and is quick to forgive and forget. I would very much like to see these unfair and biased practices cease.




EC -104