Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -239

Accepted - Volume 4

Comment Record
Commentor Ms. Kraylen Miholer Date/Time 2002-07-28 17:45:04
Organization Mannatech
Category Dietary Supplement Industry

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? All drugs, herbals, dietary supplements should state not only the good (claim, structure/function, etc.) but any contrindications, side effects, etc., as a result of clinical trials or other testing.
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? Drug advertising is, currently, mostly an emotional sale, with the manufacturer playing with the psychology of the consumer. The potential side effects, or the actual percentage of effectiveness is downplayed. Not good! The public should have more information.
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 look at the facts, as proven in scientific studies (peer-reviewed published), or clinical trials. And be honest. It is well known that vitamin C will prevent/cure Scurvy, but under current FDA rules, it's illegal to say so. What hipocracy!
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? Absolutely. The public should be able to make informed choices.
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? Presenting the actual facts, up front, should be effictive. Consumers' attention is more visual then auditory. And they listen more than read, so audio/visual is best.
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 advertisements are totally emotional : that this product and you can play football with your grandchildren! is the implication. The manufacturer doesn't want to confuse the consumer with the facts, though thank goodness, they are required to list side effects. A picture is worth a thousand words, so it's very difficult to appeal to the emotions via a lable.
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? This is already the case re: pharmaceuticals, or herbal products marketed by big pharmaceutical companies.
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? Properly prescribed pharmaceuticals are the #4 cause of death in the USA. Do consumers actually realize that? And are they aware of drug interaction? Whom is the FDA protecting?
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Allow up-front-proven honest marketing. Include contra-indications and other side effects. Allow nutraceuticals to have equal opportunity to discuss actual scientifically proven benefits.

EC -239