Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -181

Accepted - Volume 4

Comment Record
Commentor Ms. Alexandra Burchette Date/Time 2002-07-25 16:31:37
Organization Ms. Alexandra Burchette
Category Dietary Supplement Industry

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? I believe that it is the responsibility of every individual to educate themselves in regard to their health and well being, hence the DSHEA Law, 1994. To limit the freedom of speech in product labeling would make it impossible for the individual to do their due diligence, making a mockery out of the DSHEA Law. Drugs should have more comprehensive information available to the public. They are not tested long enough, they have interactions with eachother, they are highly toxic and have caused needless deaths. Dietary Food Supplements are FOOD, not toxic drugs. It appears that there is far too much cow towing to the pharmaceutical companies by government agencies. IT IS TIME TO LISTEN to the taxpayers instead of being blackmailed by the pharmaceutical industry. Let the consumer make an intelligent choice. It is sad that so many of us no longer trust the government to have the consumers' best interest at heart.
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? It appears that the FDA is in the Pharmaceutical Industry's pocket. Compliance issues only challenge the Pharmaceutical Industry to manipulate semantics to their advantage. The questions above are ridiculous. Of course people are prescribed far too many medications without either doctors or patients understanding the potential risks. The Pharmaceutical companies budget funds which essentially 'bribe' the doctors to write more prescriptions. Too many in the medical industry have allowed themselves to be influenced by the almighty dollar, fortunately not the entire medical community, some still have integrity. I cannot believe that the FDA expects the public to think that the agency is so naive as to ask such ridiculous questions.
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? The FDA is well aware of false claims by major food companies and has chosen to ignore them. What about the harmful, proven effects of artificial sweetners manufactured by Monsanto? Does the FDA knowingly approve products that are proven to be harmful, ignoring their responsibility to the consumer, for political reasons? Seems to be the picture.

EC -181