Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -101

Accepted - Volume 2

Comment Record
Commentor Dr. Dale Carroll, J.D., CLU Date/Time 2002-06-02 14:43:22
Organization United Plans, Inc.
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? Freedom of speech should allow anyone, in any capacity, to advertise the supposed benefits of any and all kinds of medicines, herbals,vitamins, supplements, etc. My wife and I have both found cures for several medical conditions using alternative treatments, etc. To allow the drug companies to freely advertise to the public on TV, radio, etc., the claims for their prescription and OTC drugs without also allowing people offering alternatives the same rights is a ludicrous denial of freedom of speech and also equal protection.
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? Several countries (Mexico for one)allow anyone to purchase prescription drugs without a doctor's prescription. The FDA should butt out, and not, in any way, have the power to restrict access to any alternative medical pharmaceutical drug or other product,vitamin, herb, etc. Giving the public more information about alternative products, treatments, etc., would enable senior citizens to find a number of supplements that would be cheaper than prescription drugs, thus reducing Medicare costs substantially!!
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? As Obesity is one of our greatest health problems, it is imperative that education about the uses of all kinds of supplements be given to the public. Now, ads only have to list the top 2 or 3 major known side effects, thus grossly misleading us. And, the drug companies should be made to inform the public of the existence of altermative, non-prescription supplements that might work better (and cheaper)!!
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? Disclaimers should be in the same size type and given equal prominence with claims!!
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? Every time a prescription drug is advertised, they should be made to pay for a counter-advertisement notifying the public of the alternatives available to them to reduce their costs (and Medicare's costs)or even increase the effectiveness of their treatment.
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? Pharmacists, health food store employees, doctors, nurses, and others involved in medical fields should have to complete continuing education courses in alternative treatments and supplements,so they can give clearer explanations of all the alternatives available.
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? Many thousands of people die each year from side effects of prescription drugs, and mixing of them without any idea by the physicians prescribing them as to their combined effects with other medications. Records should be kept of the success rates from non-prescription or OTC supplements, as well as of prescription drugs. (Synthroid is an example. Had records been kept, many people would have been able to lead better lives)
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? See 7 above. FDA should not have power to ban or prohibit distribution of any alternative pills or treatments unless they can provide double blind studies showing exceptionally large number of side effect/contraindications for each specific supplement or alternative treatment.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? FDA should employ many more persons to do research and testing of the many alternative supplements and treatments ASAP. Many of them are well known to a few physicians to be better than existing FDA approved medicines/treatments. If this is done, the costs of treatments will be substantially reduced, benefitting us all, and also reducing Medicare costs for all senior citizens.

EC -101