Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -185

Accepted - Volume 4

Comment Record
Commentor Mr. David Wallin Date/Time 2002-07-25 17:23:53
Organization Mr. David Wallin
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? The FDA controls restrictions about health claims that food supplement companies are allowed to make, but food supplement companies do not have control over what claims the FDA can make about their products. Yes, the FDA has more first ammendment rights than do food supplement companies. Complementary medicine (food supplement therapy working with drug only therapy) gives the consumer the best chance for optimal health. The drugs only approach to health care has killed far too many people - see The Journal of the American Medical Association, July 26, 2000 edition, pg 483 to 485.
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've seen healthcare videos that show physicians debating over whether or not the products approved by the FDA are the number four killer in America. When the consumer is convinced that he or she needs to be taking adidional drugs, is that consumer advised as to what are all the potential side effects when all the other drugs that person is taking are combined? I know of no such study that would be able to accurately advised the user to the combined effects of all of the drugs that have been prescribed to them. Since the FDA has decided to spend more money on advertising instead of research, an increaing number of people are going to thier physicians and telling them which drugs they would like to try.
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? Of course, potential side effects should be included. Regarding how information presented can be non-misleading, the following should be considered - If a food supplement can actually decrease the risk of heart disease and the lable is not allowed to indicate this potential, then the lable is misleading. I do not have the answer to this question, but if a consumer is not allowed to have the true information about a specific food supplement's role in assisting the body's healing ability, then you have misled the consumer (and possibly intentionally).
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? Yes, especially if the potential side effects are likely to be greater than the benefit. It appears that profit, not healing, is the goal when the smaller benefit is enphasized more than the larger potential side effect (such as death, blindness, liver damage, etc.). The smaller the print, the less likely the consumer will read the message. The more mumbled the disclaimer, the more it is presented as not so relevant information.
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? The consumer is already confused by profit mongering. It seems true that there is no profit in healing. Even though, this is a marketing question, credibility of those pushing drugs would increase if they had more knowledge of nutrition. Did you know that glyconutrients are considered by scientists to be the fourth ESSENTIAL category of nutrients?
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? It appears as though a greater emphasis on teaching nutrition and the United States culture and history in the public schools, might be more imporant than teaching elementary school students about non-arital sex. The newpapers are typically written at the sixth or seventh grade reading level. We need to improve the reading ability of our people so that date on lables can be more informative.
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? Do not know.
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? Do not know!
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Allow the food supplement industry its First Amendment rights as indicate in the DSHEA act. Avoid doing anything to weaken this act as it provides the consumer with an alternative over the cut, poison, and burn therapies of allopathic medicine.

EC -185