Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -19

Accepted - Volume 1

Comment Record
Commentor Mr. Adrian Massie Date/Time 2002-05-28 20:47:24
Organization Retired
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? None. I have the right and I exercise to consume the dietary supplements which has placed me in the top 5 % of health people over 60. The FDA wants to stop what I know is good for me.
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 concept cannot be education ius great unless it involves the FDA. The FDA is a political government body and is not a regulatory body as they advertise. The research is slanted the way they dicate and everything that does not agree, theyu are against. The FDA has killed more people than they have saved because of regulatory actions which are illegall but the drug companies have to comply because new products are approved by them. The FDA should be required to split the drug approval from the plant regulations just as consulting is split from investment banking. Absolute power kills. The reason biotech products are not bewing approved is because of the FDA's participation in politics to hold down health carte costs and not the effectiveness odf the products.
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? Daily best dietaty amounts are unknown.The FDA has not been around long enough to have studies for the entire history of mankind and the concepts are based on life expectacies of 30 years less than the likely lifespan of young people. Land has less trace elements today aand therefore dietary supplements are a requiremnent. Life habits determine what a person needs and not the FDA.
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? NO
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? Warnings a are a waste of time because the FDA is wrong so how can they warn.
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? History is a much better argument for claims than studies with predetermined outcomes If the FDA were so good then the weight issues in American society would not exist. Your record is terrible.
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? No. People have a vested interest in living. The FDA is only interested in control and all outcomes are affected by that power concept.
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. The FDA is not a medical expert for each individual.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? The FDA should absolutely stay away from dietary supplemnets expect to labell the contents accurately.




EC -19