Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -74

Accepted - Volume 1

Comment Record
Commentor Mr. Wilfred Mische Date/Time 2002-05-30 03:37:24
Organization Progressive Voices
Category Consumer Group

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? Yes, the crucial factor to be weighed is whether the producer and distributor of the drug or supplement is motivated and organizationally structured to enable all who would benefit by the product to obtain it without possessing the ability to pay for the product. This should indicate whether the producer or distributor wants to help people be healthy, regardless of the cost of production or distribution. It should also declare a need for the FDA to serve as a national subsidizer to provide drugs and supplements to people in need. If it does that, the public will overwhelmingly support funding the FDA despite all its opponents.
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 present FDA function creates support for the church of modern medicine with a protection for the established hierarchy of drug companies and the medical establishment, based on profit. Meanwhile, medical practice is more and more distrusted by the public because the medical establisment relies mainly on its cut and poison technology. The huge cost of traditional medical practice offers little hope for supporting good health and healing. The commercial industries that legally sell dangerous substances for personal abuse are not challenged by the establiished medical system. And people don't trust it to free them of the addictions which are induced on the public from childhood on. The FDA needs to articulate a valid vision of supporting a natueal health regime as an appropriate potential for all people and not a contrivance created by a vested medical establishment to only alleviate the sufferings of ill people after they have adopted dangerous lifestyles.
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? Require producers to list at least one source at which consumers could find available information that explains the characteristics and functions of the ingredients of a product and the value in using the product.
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? The producer of the product should hold the obligation to inform the user about the prouct and let the law be the recourse for the user if the producer distributes a product that does not match its advertising. The FDA should promote natural health care.
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? Instead of issuing warnings, the FDA should be urging the use of natural therapies that have a history of valid use and should teach people how to find them and use them.
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? Lawyers and even establishment doctors have little if any knowledge or training about the basis of naural health. To expect then or social scientists to judge or determine policies in the use of natural health alternatives is like expecting elephants to fly. The judges of natural health issues should be found in the natural health discipline and not in law or social science.
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? The law and act that established the FDA was put in place by the medical establishment to protect the establishsment. Can the FDA change and become legitimately interested in promoting natural health? Not likely, how would the doctors, hospitals, drug companies, etc. react if people stayed healthy and didn't need any of those vested establishments? Find some way to make people sick so they could stay in business? Probably. Remember the Opium War?
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? What concerns is the What concerns is the FDA designed to address? It is clear that it isn't the public concern for natural health. the FDA should start promoting alternative health regimes that don't rely on the medical establishment. Then the establishment practitioners might choose a more lucrative field and leave health to the people who are motivated by the vision of natural health.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Probably those that oppose what I have stated.

EC -74