Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -10

Accepted - Volume 1

Comment Record
Commentor Mr. Charles Marcus Date/Time 2002-05-28 18:47:53
Organization Mr. Charles Marcus
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? Yes. prescription drugs are in a completely different category from virtually all dietary supplements. Dietary supplements are, in the vast majority of cases, harmless if directions are followed, and most are harmless even if taken in large quantities. Prescription drugs, on the other hand, in the vast majority of cases, have toxic side effects, and can be fatal if recommended dosage is exceeded, in many cases even by a small margin.
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? FDAs current approach is monopolistic, and in many cases, borders on racketeering, in its promotion of unnatural, prescription drug-based remedies, as opposed to natural, herbal and food-based remedies. It routinely attempts to violate the free speech of men and women who have web sites that promote natural remedies.
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? People are not stupid. All disclaimers do is create fear, uncertainty and doubt in the minds of people who might otherwise try natural remedies. Many prescription drug claims are based on fraudulent studies (or fraudulent interpretations of studies), as can be easily shown by the number of drugs that wind up having to be recalled due to many deaths.
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? There should be no disclaimers neccessary.
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? The only times warnings should be mandatory on a product is if it has been proven that a product causes certain symptoms or problems.
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? I see no difference between the two. The only thing that should be punished is outright fraud. Even if there is only anecdotal evidence that a product does something (is good for the liver, say), then that should be allowed, both in advertising and on the label. The only thing the FDA should be concerned about are products that are dangerous to peoples health - and virtually no one has ever died from dietary supplements, and millions of people have died from prescription drugs over the last 20 years.
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? Only for dangerous prescription drugs. Dietary supplements are food, and should not be regulatable by the FDA, except in cases where death can result.
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 - get out of bed with the pharmaceutical industry, and stop worrying about efficacy - the only thing the FDA should ever be worried about is safety.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Yes - the people in this country have the natural, God-given Right to treat themselves, without any interference by the government, even to the point that they endanger themselves. Get out of my life.




EC -10