Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -180

Accepted - Volume 4

Comment Record
Commentor Dr. Jan Morse Date/Time 2002-07-25 16:06:13
Organization Dr. Jan Morse
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? In my opinion as a Doctor of Chiropractic who has worked with many patients over the last 20 years I feel very strongly about the positive preventative and overall health effects of many nutritional supplements. There are a number of products such as glyconutrients( )in which there are thousands of research articles that show the positive effects of these substances in relation to a number of different disease conditions let alone the thousands of anecdotal first person testimonies. It is my opinion that the FDA is doing the public a diservice by requiring labeling such as 'not approved by the FDA' and by not allowing referrences on products to scientific research that show the positive effects of these supplements.
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 FDA's current approach regarding perscription drugs has lead to an overdrugged society in which we tell our child to just say no to drugs and then introduce them to their first ones at a very early age by their pediatrician. We also have a situation in which many elderly people's greatest monthly expense is their drugs. These and their advertising should be more tightly controlled while the use of dietary supplements that are shown to improve health and reduce the risk of certain diseases along with freedom of use of scientific research relating to them would help reduce the problems encountered by children and seniors.
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 no basis to believe that consumers approach claims about conventional foods and dietary supplements differently.Both foods and food supplements can be dangerous to some few people who may have alergies or overindulge. As long as ingredients are carefully listed and specific warnings for well known conditions are listed there is no more reason to restrict the supplements than to restrict a tomato.
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 should be in the same type and given equal prominence with 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? Let the buyer beware. The patient has the responibility to read what is on the label and be responsible for their own health.
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? No the first amendment does not afford the government greater latitude over labels.
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? Permitting speech by manufaturer, distributor and marketer about off-label uses would not undermine the act's requirements. It would allow people to make choices for themselves.
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? No they do not. These regulations interfere with the publics health concerns.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Yes. Remove restrictions that keep manufactures, distributors and consumers from making true, scientific claims about products or giving their personal experience.

EC -180