Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -229

Accepted - Volume 4

Comment Record
Commentor Mrs. Revilla Hegwood Date/Time 2002-07-27 13:51:20
Organization Independent Mannatech Associate
Category Dietary Supplement Industry

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? YES! ALot of deaths occur from drugs! Very few adverse reactions come from dietary supplements. A speech made to learned intermediaries is scientific education, one to consumers is usually promotional. Many advertisements today are misleading. Lack of ethics and truthfulness is the basis of this prevalent practice.
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? No. Even if it is not a deliberate contrived action of the pharmaceutical companies the result is the same--over use and over prescribed drugs, increased physician visits, eventually leading to more drugs to treat drug induced problems and symptoms. F.D.A. approval has nothing to do with patients understanding of the dangers & risks of drugs. A picture is worth more than words and advertising uses create a belief of safety and need beyond reality. Doctors appear to be caught in the middle of scientific treatment and patient demands.
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? It would seem that many so called conventional foods are not really food at all! Many prepared and processed foods are really junk and of little or no nutritional value. Dietary supplements of high quality are certainly approached differently by the consumer. Disclaimers often confuse the user of potential benefits.
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 both are honest and truthful equal prominence is in order. It however appears that many disclaimers are only to protect the pharmaceutical industries cartel on health and healing.
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? In the use of drugs, USE ONLY AS DIRECTED BY YOUR HEALTH-CARE PROVIDER would go a long way toward putting responsibility in the right place for adverse results. In the case of dietary supplements, Label amounts of recommended intake advised unless your healthcare provider suggests otherwise.
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 IMPORTANT THING IS ALWAYS TRUTHFULLNESS! LABELING SHOULD NOT BE ADVERTISING.
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? NO. MANY PEOPLE SHARE INFO ON THEIR PERSONAL EXPERIENCES WITH PRODUCTS THAT HAVE NOT BEEN REVIEWED BY THE FDA. THERE IS VERY LITTLE ABILITY TO CONTROL THOSE KIND OF COMMENTS.
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? NOT ALWAYS. THEY COULD JUST ADMIT THEIR MIGHT BE OTHER USES OF A PRODUCT THAT THEY ARE NOT AWARE OF!
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? PLEASE JUST GIVE INDIVIDUALS FREEDOM TO CHOOSE AND USE AND EDUCATE THEMSELVES WITHOUT LETTING THE DRUG INDUSTRY CONTROL ALL ASPECTS OF WHAT IS CONSIDERED HEALTHFUL AND HEALING!




EC -229