Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -85

Accepted - Volume 2

Comment Record
Commentor Mr. Peter Hudiburg Date/Time 2002-05-31 10:58:33
Organization Mr. Peter Hudiburg
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? Yes. A drug is a synthetic concoction, the research has been performed by the company. The concoction has health side effects. A dietary supplement, if not synthetic, but derived from food, and not molecularly altered for purposes of patenting, is a substance that does not have health side effects and therefore should not be regulated.
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? Advertising of drugs to consumers is misleading in that it creates a desire for an synthetic substance with unknown or underemphasized side effects.. On the other hand, the FDA has no business regulating food supplements because its corrupted business has been to favor the large drug companies who make large contributions to politicians. The executives of these large drug companies become the exectutives of the FDA and vice versa. The resulting conflict of interest is responsible for the constant harrassment of food supplement makers and health food stores and even alternative food supplement consumers.
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? The FDA should keep in mind what the first amendment guarantees, namely the right to free speech. The FDA has been preventing food supplement makers from citing studies proving the benefits of food supplements.
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 FDA must learn to observe and obey the first amendment.
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? Warnings should be on synthetic drug packaging but the FDA should stay away from regulating food supplements.
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 FDA is so corrupted that its authority over food supplement makers and helath food stores and health food consumers should be further restricted.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? The FDA should be restricted to its inept and highly corrupted psuedo regulation of the drug industry, not the food supplement industry. The FDA has no right to prevent food supplement makers from listing health benefits of a product when supported by studies.

EC -85