Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -89

Accepted - Volume 2

Comment Record
Commentor Mr. Robert Unger Date/Time 2002-05-31 19:17:59
Organization Mr. Robert Unger
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? Being a consumer, in your words NOT a learned intermediary, I can only relate to the commercials seen on TV and heard on the radio. I would not use most of the drugs advertised because the side effects are more damaging than the cure.
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? I feel that you regulate the DRUG industry quite well.
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? With all the scientific evidence relating to foods good or bad is there a requirement that should separate supplements from this category? I read in the paper that butter is bad for you, and then a week later read that the transacids in margerine when heated is worse. What regulation is needed for all types of food? Breathing oxygen too long is bad for as well. I always thought that dietary supplements were exactly that supplements. If taking a particular dietary supplement will reduce your chance of getting high blood pressure, or chance of lowering your cholesterol (LDL), what harm is done by allowing the producer to make that claim (Using XXXX may reduce your chance of getting high blood pressure).
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? I feel that the prominence of the WARNING, or CAUTION, or NOTE could be the same height, but clearly separated from the 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? I feel that your warnings associated with drugs are for the most part accurate. I don't feel the same with dietary supplements. Your warnings or I should say statements are a little beyond the bounds of reality, and tend to discourage people from ever taking the product with your wording. The one that really gets me is the warning about the producer's statement about the product - This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease. First - if the the producers statement has not been evaluated what is it doing on the shelf? I guess the pills won't hurt you because it is a dietary supplement. Second - How can a dietary supplement diagnose, treat, cure or prevent a disease? Shouldn't that language be reserved for DRUGS?
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? If the product can be advertised over the air as doing a particular function, then the labeling should reflect the same language along with any known side effects, and other drug interaction.
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? The FDA does not have the resources to hear all the off-label uses that can be generated by PEOPLE. I know that you are concerned with manufacturers making off-label use to customers, and should pursue them to that end, but you will never stop rumors.
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? I wouldn't touch that. I believe that is in hand assuming that you are refering to the airwaves.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Yes. If a product , by taking it, may reduce the chance of getting a known physical malady or detrimental condition then the manufacturer should be allowed to make that statement. The science is in, and the dietary supplements are just that; supplements. If a person can increase his chances of staying healthy, then let it be. Unless the primary mission of the FDA is to underwrite the drug industry, and the ADA.

EC -89