Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -226

Accepted - Volume 4

Comment Record
Commentor Mrs. Carol Troyer Date/Time 2002-07-26 20:00:34
Organization Mrs. Carol Troyer
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? Almost all drugs have myriad side effects which drug companies would rather we wouldn't know about. The fourth leading cause of death in the USA is prescription drugs. Since that is part of the public record, it seems that the drug industry MUST be regulated more closely. The problem is that the drug companies have the money for lobbying Congress. Also, many drugs are passed without proof of double, blind studies and later need to be pulled off the shelves. In the meantime, drug companies rake in huge profits and people suffer side effects never discovered before. A synthetic substance almost always interferes with something in a human body--no wonder the drug companies feel so threatened when good results come from something natural from nature. I think the food/dietary supplement companies should be held to GMP's (Good Management Practices)in that the product should definitely contain what the label says--not more and not less.
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? The drug companies have the advantage right now. A lot of Americans rely heavily on what their doctor says. The people who educate themselves on different products outside of the drug industry are penalized in that food/dietary companies are prohibited to say what has worked for other people. Why is it so harmful for people to get the information and then make their own choices? If food/dietary products have in them what the label says then let us make our own choices. After all, we have a much higher percent chance of dying from a drug than from any food unless we are allergic to it. With the over advertisement of drugs everywhere we look, people tend to think that there is a drug for every possible thing that could be wrong with them. They insist in having drugs and doctors are sometimes hard pressed to withhold them. Patients often don't care enought about the side effects until they start experiencing them and the health problems escalate. The doctors that do try to incorporate natural alternatives into their practice are ostrasized by other health professionals and by drug companies. It doesn't seem to matter that the results are most often positive. The fact that there are many postive results from natural products is a big threat to the drug companies and they try to bully the FDA into doing what's best for them (the drug co.'s). The way things are slanted for the drug companies does not make me feel safe when it comes to my health.
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? If the dietary/food company has scientific evidence of something helping a certain condition, they should be able to say so publicly. If there are anecdotal evidences, I for one, want to know about them and then make my choice.
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 on drugs are so small that a person almost needs a magnifying glass to read them. I think it's more important on drugs than food/dietary products.
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? Truth in advertising is very important. It can be the difference between life & death.
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? As people use products for one condition, they discover good results for another condition. They should be allowed to share those results.
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? The speech-related regulations greatly suppress the good results obtained with food/dietary supplements in that we legally can't share those good results publicly.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? I think every American & American company should be allowed to share their experiences with others--that's our constitutional right!




EC -226