Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -214

Accepted - Volume 4

Comment Record
Commentor Dr. Ron Violet Date/Time 2002-07-26 11:39:48
Organization Dr. Ron Violet
Category Health Professional

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? I often get asked by people about drug advertisements. As a naturopath doctor, I don't prescribe drugs(nor would I want to) but I do have greater knowledge than the general public about the use of drugs and possible dangers. I find the ads to be misleading leading people to believe that except for a few minor side effects, they are safe. I think that when drugs that are properly prescribed in a hospital cause the deaths of 100,000+ people is far from being safe. If people were told how many people die of all drug complications at the beginning of an add, they wouldn't consider them as a viable choice.
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 see only negative effects of these adds. They get people to believe that drugs are the only answer to their problems. Whatever happened to a drug free America? Doctors find themselves in an untenable position. If they don't prescribe the drug the patient is asking about, the patient finds another doctor. Doctors really don't have the time to educate the public about the real problems concerning side effects on all drugs especially when used in combinations.
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? There is ample information about food and supplement use. The FDA seems to want to limit DSHEA and information that the public gets. The lawsuits against the FDA made it clear that the FDA has no scientific basis for doing what they do...limit the information to the public and violate the laws of Congress. What standard of proof is required for making claims about food or supplements is difficult to state. Since eating vegetables is relatively safe(except for the pesticides), the level of danger is small compaired to the potential benefit. With supplements the benefit vs potential danger must be evaluated. With the current thinking, this cannot be done fairly. Example: the study on St. John's wart vs antidepressant drugs. The herb was one persentage point less effective than the drug, but the conclusion was that the herb was not effective. What bothers me about evaluations in general is the dismal record the FDA has with drugs. It seems that after the drug has been approved by the FDA, some time down the road we find out that research done in Europe that says the drug was unsafe is overlooked as was the fact that the research done seems to have been poorly done. Maybe we need to keep the FDA out of the food and suplement evaluation process. Creating a new agency is the only answer. What bothers me is how long will it be before the new agency will be biased by various special interests groups.
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 and warnings should be the same size. Problem: Will the bottles need to be so large to contain all claims and disclaimers that it will be impractical for the manufacturer and consumer?
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? We seem to be worrying about preventing possible harm from substances that are relatively safe compaired to drugs which seem to be seen as safe because doctors prescribe them. One study said that basically medical errors and use of prescribed drugs are the first leading cause of death in America. Maybe we should be looking at the real danger...Drugs(all are toxic) that are used to treat symptoms vs adressing the cause of disease.
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? Our First Amendment rights should be first and formost. An individual can gain information from books or professionals and make a choice. All I want is for some agency to guarantee that what is on the label is infact in the bottle at the stated amounts.
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? If you are talking about off use of drugs, the FDA should not permit it unless the use is for a life threatening condition. If not studies must be done.
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 see the FDA as an extension of the drug manufacturers. They want to keep the competition of alternative approches down to a minimum and keep the informations about the dangers of drugs hidden.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? The FDA should Allow the public free access to ALL information regarding supplements and the therapeutic use of food. They should also follow the intent of the DSHEA act or loose their jobs.

EC -214