Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -92

Accepted - Volume 2

Comment Record
Commentor Mr. Gary Bright Date/Time 2002-06-01 02:15:15
Organization Mr. Gary Bright
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? The FDA is just another government entity that would like to be much more important than it is! Let the people deside for them selves what they need or want. Quit trying to be almighty God, and obey they laws of the land.
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? The highest court in the land decided that the FDA was over steping its authority. ENOUGH SAID !!!
3. May FDA distinguish claims concerning conventional foods from those relating to dietary supplements, taking into account limits on claims that can be made about foods in the Nutrition Labeling and Education Act, 21 U.S.C. 301, 321, 337, 343, 371? What must an administrative record contain to sustain or deny claims on food labels? How can information best be presented in a succinct but non-misleading fashion? To what extent do assertions in claims need qualifications or disclaimers added to the label to avoid any misconceptions that consumers may draw? Is there a basis to believe that consumers approach claims about conventional foods and dietary supplements differently? Let consumers decided for them selves what they want, whether it is on a dietary supplement or bread and butter.
4. Should disclaimers be required to be in the same (or smaller or larger) size of type and given equal prominence with claims? Is there any relevant authority or social science research on this issue? If the consumer is going to read the claims, they will also read the disclaimers. I have not heard of even one case that dietary supplement has harmed anyone, but I have heard of many, many cases that people were harmed because they did not know about some of the supplements.
5. How can warnings be made most effective in preventing harm while minimizing the chances of consumer confusion or inattention? Is there any evidence as to which types of warnings consumers follow or disregard? Get the FDA to hell out of the way so that the info can get to the people that need it.
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? The first amendment is just a conformation of a God given right to free speech. The FDA is nothing more than a socialist, nay, a communist dictator (self appointed).
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? Lets do away with the FDA completely! They, the FDA, is just one of the reasons that the U S is falling behind the rest of the developed world in assisting the general public in living a healther life.
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? FDA regulations does NOT advance public health. The only thing FDA regulations do is prohibit the public in educating it self.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Yes, the FDA should back off and do as the Supreme Court, as well as many lower courts have said and quit acting if they were GOD.

EC -92