Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -98

Accepted - Volume 2

Comment Record
Commentor Dr. Clifford Garner Date/Time 2002-06-01 16:29:51
Organization Dr. Clifford Garner
Category Health Professional

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, drugs are inherently toxic and harmful, dietary supplements extremely rarely. Much promotional speech about drugs is very misleading, favoring the pharmaceutical industry naturally.
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? Of course drugs are overprescribed and the FDA has always sided with the pharmaceuteutical industry (with which it exchanges personnel often. It's a rare patient that has any appreciation whatsoever regarding the benefits (often none) and hazards of drugs (often severe).
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? How about some fsacts for a change? Dietary supplements often help people and rarely harm them--read up on the excellent reseatrch and record of Julian Whittaker, MD, in the use of dietary supplements often, in place of hazardous or ineffective drugs.
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? No opinion
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? To start with watrnings should be based on facts, not on the FDA's desires to promote drugs. My guess is that few consumers pay much attention to warnings, either of dietary supplements or drugs--not much in the way of warnings for latter (consumers rarely read the PDR!).
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? Either way the truth should be presented. I don't know.
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? Drugs certainly ought to be approved by the FDA, although its sometimes obvious ignoring of adverse evidence in order to push a drug on to the market is not a secret.
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? Tell the truth, instead of loading the dice in favor of drugs and restricting or abolishing dietary supplements or allowing only ridiculously low dosages. FDA's representative to the Codex Alimentarius attempts to put dietary supps under prescription attests to that.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Honor the recent ruling by many courts including the Supreme Court about First Amendment violations by the FDA.




EC -98