Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -61

Accepted - Volume 1

Comment Record
Commentor Mr. Douglas Troop Date/Time 2002-05-29 12:44:30
Organization Celestine Trust
Category Other

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? Dietary supplements are not made by the Drug Companies who the FDA is SUPPOSED to regulate, because the FDA is regulated by those same Drug Companies through a revolving door policy of management that has continued at least over the last 1/2 of the 20th Century to my personal knowledge. Unfortunately, this has been true for the FAA as well, to the detriment of the American public. The FDA is perceived by the public as being pro Drug Company and anti food supplement industry, and with obvious validity. This has harmed the American public's health, to the benefit of the Drug companies. Take the use and promotion of Prozak, for example. Prozak has had well over 10,000 seriously adverse affects on patients who have taken it, causing them to become suicidal and in some cases mass murderers, a fact that can be directly attributable to the presence of Prozak in their blood. Vitamin B17 is another case in point. B17 can cure some cancers but is outlawed for sale in the US. The only reason for it being outlawed is that it cannot be made by the Drug companies, or thus profited from. Keeping effective natural remedies from the public, warning or inferring that the public taking such remedies may be harmful is not in the public interest. Fair and accurate labeling is in the public interest on any product, especially in providing FULL information about a health product, which has been unlawful by the FDA. Just why would that be, unless it was not in the economic interest of the Drug companies. The top management of the FDA is corrupt, and needs to be cleaned up. The medical profession is deeply involved in this matter. The medical profession, by definition, has become a legal drug pusher for the Drug companies. The American public has become totally conditioned to believe that going to the doctor means getting a prescription. And if this does not occur, they are really disappointed. That is true conditioning.
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 advertising of drugs on television has gained increasing momentum in the last 10 years. Feel tired, take A. Feel drowsy, take B. Feel depressed, take C. Feel low energy, take D. Suffer from hayfever, take E. Feel pain, take F, G, H, I J and K. But watch out for all of those side affects, especially sexual side effects. And what are those? Hmmm. The advertising of cigarettes was finally outlawed when after 70 years we finally realized that smoking was bad for one's health. How dumb. Broad public Advertising ANY type of DRUG, from ALCOHOL, to Cigarettes, to PROCRIT to PROZAK is simply WRONG, because is ENCOURAGES dependence on drugs, which is what the Drug companies WANT, but which is against the public interest. No kidding, it really is. We encourage parents and kids to Say No to Drugs and then bombard them with drug advertisements daily. Is this sane? Is this good sense? Or is this really criminal self interest on the part of the Drug companies and the FDA which allows it?
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? All of the questions that have been asked above, and probably below, are carefully worded to sidetrack the respondent about the basic issue: Who does the FDA protect, the Public, or the Drug companies & medical establishment? the answer is OBVIOUSLY the latter. Certainly not the public.
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? The most important issue is: Can the information be easily read? In most cases, the type is extremely small, and must be read using a good magnifier. That is wrong. We are supposedly living in an information age. Let the information be obtainable and let the facts fall where they may. Let the public decide what it wants and needs, not obvious vested and profit driven interests.
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? Full disclosure of information on any product is essential, both good and bad. But for God's sake, do not outlaw good information on food supplements and minimize bad information on drugs, which has been done; case in point: Prozak, now even being pushed as a dietary weight loss drug. My God! How many parents are truly informed about the adverse affects of their children being given (forced to take) Ridalin?
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 only first amendment issue in my mind is: Is the statement telling the truth, or is it misleading? Can the statement be supported? If so, then by all means, say it or print it. If not, then it should not be stated or printed. The question is, who determines who can say what? The FDA, as a vested interest, is entirely suspect of what it says is permissable. Therefore, let the standard of truth be set as a public policy, and if a product has false claims made about it that result in damage or death, then let the legal system handle it by hungry attorneys, and keep the FDA and the Medical establishment out of it.
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 issue is one of censorship. Censorship is simply not part of a free society. Censorship is simply CONTROl. This is NOT OK in the US of A. The FDA has destroyed its credibility as a public agency, and much of its power should be removed and/or downgraded to being an oversight agency designed to put ethics in on the drug companies it is supposed to be regulating, but has in fact been encouraging.
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. Yes. Let the free market determine the efficacy of a product.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Yes. Just make sure ALL the information on a drug or food supplement is made available, both psitive and negative, and then let the American public make its own EDUCATED decision on whether to buy the product or not. Doctors will continue to push the drug company products, but doctors just might be encouraged to learn a lot more about food supplements to the benefit of their patients.




EC -61