Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -250

Accepted - Volume 4

Comment Record
Commentor Mr. Norman Phillips Date/Time 2002-07-29 02:50:14
Organization Mr. Norman Phillips
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? Toxic pharmaceutical drugs should be strictly regulated and not advertised to the general public.
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? Current commercials of toxic prescription drugs on television and print should be immediately banned. The pharmaceutical companies have proven themselves to be even worse than snake oil hucksters of past generations. Consumers want the drug even though the toxic, and often lethal side effects haven't been studied or ascertained. The doctor must give it to them or risk losing a patient.
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? Stardardization of all ingredients must be maintained on all dietary supplements. Furthermore, what is in the bottle or container must be on the label in the amounts specified - no more, no less. If a dietary supplement or food has been scientifically proven to help, cure or ameliorate a disease or condition, such claim should be allowed on the label.
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? There should be no disclaimers.
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 about toxic pharmaceutical drugs and their individual side effects should be very prominent in all literature and detailed by the physician to every patient.
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 should strictly regulate toxic pharmaceutical drugs, not dietary supplements.
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? All off-label uses of toxic pharaceutical drugs should be strictly regulated like a new drug. Double blind studies of combinations of pharmaceutical drugs should be required before using combinations of pharmaceutical drugs.
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? Dietary supplements should be left alone, except in the case that it has been conclusively and scientifically proven to be toxic or lethal.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Stay away from dietary supplements except for requiring standardization and labeling to give exact amounts of ingredients found in the bottles or containers.




EC -250