Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -253

Accepted - Volume 4

Comment Record
Commentor Mr. VICTOR G Pierson Date/Time 2002-07-29 10:29:13
Organization Mr. VICTOR G Pierson
Category Dietary Supplement Industry

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? I want the public to continue to receive the benefits of the Dietary Supplement Health in Education Act(DSHEA) 1994. I, and others like me who have received great benefits from Dietary Supplements, must continue to be allowed to receive the information relative to NON-prescription drugs/foods. Pharmaceutical companies and their lobbyists MUST NOT be allowed to take away our right to be informed by the evidence of over 20,000 scientific studies conducted over the last 20+ years showing the benefits of glyconutrients and other foods when introduced into the human body. Even the wise individuals of 2,000 years ago said to look to nature to find the answer to many/most of human ailments. Nature IS providing healing answers far beyond those being foisted upon the public by the pharmaceutical companies. Our bodies know how to heal themselves when given the proper nutrition. It seems that the only interest of the pharmaceutical companies is to 'get money' from the individuals by masking the symptoms of the many diseases with their drugs and to prolong the use of their drugs (lifetime, if possible) without actually curing the disease. While all drugs have an LD50 rating, their is no rating for foods(LD = 0). Currently, properly prescribed pharmaceutical drugs are the number 4 or 5 killer of humans, following heart disease, cancer, etc., and many of the current drugs are NOT as EFFECTIVE as older drugs, but because of the advertising HYPE from the drug companies become 'leading sellers' only to be withdrawn, in a relatively short period of time by the FDA after tissue damage and death cause/demand them to be withdrawn. Scientific evidence shows that the human body will actually heal itself of most diseases if given the right foods. Thus, I demand the right to continue to receive the benefits of the First Amendment by being informed, and having the protection of, the Dietary Supplement Health in Education Act(DSHEA) of 1994.
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? Do NOT change DSHEA '94
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? Do NOT change DSHEA '94
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? Do NOT change DSHEA '94
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? Do NOT change DSHEA '94
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? Do NOT change DSHEA '94
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? Do NOT change DSHEA '94
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? Do NOT change DSHEA '94
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Do NOT change DSHEA '94




EC -253