Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -204

Accepted - Volume 4

Comment Record
Commentor Mr. Robert Anderson Date/Time 2002-07-26 01:54:17
Organization Mr. Robert Anderson
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? The FDA seems to have become all about protecting big money drug companies from losing money to nutritional companies that offer REAL hope to finding CURES to diseases. I know of few if any drug companies that have ever produced a drug that CURES ANTYTHING!! All they do isd treat a symptom, often with chemicals far more dangerous the the disease they claim to be treating. While Nutritional companies are restricted from making any statements that even suggest that nutritional supplement might offer help in the treatment of a disease, even when there is strong evidence to back up these claims.
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 FDA and AMA refuse to accept the fact that throughout history the following is true: Doctors give drugs of which they know little, into bodies, of which they know less, for diseases of which they know nothing at all. Voltaire Let food be thy medicine, and let thy medicine be food. Hippocrates And we have made of ourselves living cesspools, and driven doctors to invent names for our diseases. Plato All drugs are poisons the benefit depends on the dosage. Philippus Theophrastrus Bombast that of Aureolus Paracelsus (1493-1541) We must admit that we have never fought the homeopath on matters of principle. We fought them because they came into our community and got the business. Dr. J.N. McCormack, AMA, 1903 If we doctors threw all our medicines into the sea, it would be that much better for our patients and that much worse for the fishes. Supreme Court Justice Oliver Wendel Holmes, MD The human body heals itself and nutrition provides the resources to accomplish the task. Roger Williams Ph.D. (1971) And they continue to deny these truths and fight to help big money drug companies to poison our citizens.
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? there is far more corruption in the supposed research in most drugs already approved by the FDA than most any nutritional supplements.
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? What should be required is clear labeling on products like Ritalin that they are in the same class as, and can cause the same side effects as cocaine!! And they should STOP requiring nutritional supplements to make such vague statements that it makes them appear to be useless or more dangerous than they are.
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? How about the FDA look at what the DEA says about a lot of drugs such as Ritalin??
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 FDA seems set on continuing to approve and stand behind dangerous drugs, while they fight good 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? the FDA should have little to say about it, unless there is clear, overwelming evidence that the supplements are dangerous. The FDA seems more worried about natural alternatives that at least might offer a cure, then they do about the known dangers of drugs (un-natural chemicals) theat offer NO CURE... only something to treat or alter a symptom.
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!!! They do the exact opposite!! They are so bias towards big money drug companies, it's not hard to see what the real motivation is, and that is NOT for what's best for consumers health!
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Yes... too many to list. Put the drug companies under the same scrutiny, and MORE than any natural alternative. Take PAYOLA MONEY out of the equasion, and get real about finding CURES to diseases.

EC -204