Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -221

Accepted - Volume 4

Comment Record
Commentor Mrs. Carol Thiessen Date/Time 2002-07-26 14:23:38
Organization Mrs. Carol Thiessen
Category Individual

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? People need to hear what will help and what will not help with their health. I know that a lot of information about the side effects of drugs is left out and that many drugs are approved before they have been sufficiently tested. Once they are approved many people believe that they are safe and effective even though they have serious adverse side effects. It seems to me that there is a double standard here. Pharmaceutical products, which are proven to have serious side effects, are quickly passed allowed for sale, while natural products which have been used for years with very little side effects if any are banned from being sold or promoted. This is very wrong.
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? With a major emphasis on pharmaceuticals by the industry, an unrealistic belief is formed in the general population that a cure for disease conditions can be found in drugs and that nutrition is of no consequence to general health even though there is overwhelming scientific evidence showing a connection between disease symptoms and poor nutrition. People see commercials for pharmaceuticals, go to their doctors and ask for prescriptions. The doctors do not receive a lot of nutritional education, and are encouraged to prescribe pharmaceuticals.
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? I know that the cells in my body are regularly replaced. The only building blocks for new cells come from what I put into my body. Garbage in garbage out, or quality in and quality out. If I don't get enough vitamin C for example my new cells will be deficient and I will have the symptoms of scurvy. I make sure that my conventional foods are very good quality and then supplement any deficiencies with good quality food source/matrix dietary supplements. Statements on labels which indicate that something is high in certain naturally occurring vitamins, minerals, amnio acids, essential fatty acids, phyto-nutrients fiber and other nutrients as they are discovered are very helpful. I do not choose very many products with synthetic vitamins and inorganic sources of minerals added as have found them more detrimental to my health than advantageous.
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 not be misleading and only added when necesssary. They also should not distract from the nutritional information and health 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 don't pay a lot of attention to the FDA warnings as I have done a lot of reading in nutritional books and have had a lot of experience in helping my family to regain and maintain health through nutrition.
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? We should be allowed freedom of speech. If the authorities are not open to new discoveries and different approaches, then I guess all of the scientists, researchers, inventors etc. will have to get new jobs. We need to humble ourselves and say we know a lot, but we don't know everything. Let's remain open minded. At one time, for example scurvy was rampant and the authorities of the day scoffed that it could be a nutritional deficiency. Let's not be so naive as to think we know all there is to know. Maybe nutrition plays a role in many of our chronic conditions. Maybe our health is deteriorating due to many years of toxins and poor nutrition. Maybe some one not in the field of medicine or nutrition has their eyes open and can see what is needed. Maybe the authorities are blinded because they are looking in the wrong areas.
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 FDA can do more testing on the products they want to regulate so that they can have more accurate labels. They and contract these jobs out to recognized labs. This would create more jobs and allow the testing to be done more quickly than if the the FDA were to do it by themselves. Three or four labs could be doing the same testing so that the results could more quickly be confirmed. It would also be more cost effective.




EC -221