Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -66

Accepted - Volume 1

Comment Record
Commentor Mr. George Farrell Date/Time 2002-05-29 16:43:46
Organization Mr. George Farrell
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? It is my opinion that the FDA should limit their sphere of influence to the Drug Industry. The Food Supplement industry should be left alone to provide an alternative to health care.
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 have no opinion regarding the medical field. I live my life from a prevention position. I believe in health and a healthy life style. I go to great lengths to avoid drugs, which I believe creates alot of problems in itself.
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 personally do not feel the FDA has any right to try to regulate food supplements in any way. It is obvious that the health industry is making a great impact on the health of this country. I am aware that the financial impact is effecting the medical field because more and more people are turning to health as apposed to drug dependancy. It is a very sad state of affairs when our country and its beaurocrats try to regulate our health under the guise of protecting us. Just look at the statistics regarding people who die from drugs vs people who die from food supplements. That should tell you something!
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? People like myself don't pay much attention to disclaimers because we are use to them. We do our own research into the effectiveness of a food supplement.
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? This is a hard question, because many, many people realize that there are alterior motives behind alot of warnings. Most of the time it is because of the treat that the food supplement industry is cutting into the profits of the medical and farmaceutical fields.
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? The less government involvement the better.
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? Again, the more the FDA attempts to regulate, the more we as a people come out on the short end of the stick. Normally, when regulation is the topic, money is at the root. Like so many government agencies, the purpose is good but the outcome is bad, because money starts dictating who and what is to 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 personally see many areas that should be addressed as far as safety is concerned. I see many food additives, plus flouride in our water that should be of great concern regarding our health. It seems nothing is being done about those things.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? In my opinion, the FDA should keep out of the food supplement business. I can see some benefits but when it comes to regulating, I see it as a way to try to control my right to healthy options.

EC -66