Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -25

Accepted - Volume 1

Comment Record
Commentor Mr. Hanns Derke Date/Time 2002-05-28 21:52:17
Organization Mr. Hanns Derke
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? False advertising is one thing: selective presentation of the facts is another. False advertising already is illegal: no further action is needed on this issue. Selective presentation of facts requires the reader to use his education and judgement on a case-by-case basis, and to accept the consequences of his intelligence or lack thereof. It should not be the job of the government to protect the citizenry from such selectivity: this only invites abuse of the power given, and introduces the inevitable backroom tug-of-war that invariably moves the discussion from the merit of the issue to its political ramifications, at the expense of the public interest.
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? Advertising of drugs is unfortunate, but must not be restricted on principle. The mis-use and abuse of both over-the-counter and prescription drugs is an inevitable consequence of a misguided consumer mentality combined with the massive third-party payment system which we have had the shortsightedness to develop, and cannot be eliminated without eliminating those root causes, regardless of the presence or absence of advertising. The most one can hope for in labelling and advertising is to require inclusion of performance data on each product in a manner that is easily grasped by and also relevant to the average consumer. This data might, for instance, rate such issues as overall safety, likelihood and severity of side effects, and efficacy, all rated on both an absolute and a relative scale to other paths of treatment as well as other directly competitive products. Availability of such information to both consumers and the media could dramatically reduce the present bias towards medication as the automatic answer to virtually any symptom. This would be hugely unpopular with the drug industry since it would likely reduce the current largely wasteful spending on pharmaceuticals. However, it may well improve overall health by opening the door to new solutions, while reducing the many side effects caused by approved, but only marginally effective pharamceuticals.
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? A simple way to clarify statements would seem to be a disclaimer: The above statements are the opinions of the manufacturer and have not been verified by the FDA or any other independent agency. It is impossible to completely avoid misconceptions, and it should be the FDA's responsibility to try: consumers must accept responsibilty for making individual judgements in exchange for freedom and access to choices. Another option is to offer voluntary third-party appraisal as a means for manufacturers to add value to their products. This would likely provide consumers with greater access to more products at wider price ranges: cheaper less verified products would at least be available to those unable to afford more, while those able and willing to pay more could opt for more proven solutions. This solution is far more democratic than the denial that the poor must presently suffer.
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? It would appear unreasonable to require absolute equality in type for all data on a label. Howdever, an indication of a disclaimer should be at least as large, i.e. visible as any claims headlines: the actual data could be either smaller or placed in a separate location (insert, handout, etc.). Most consumers won't read it anyway, but I believe access and availability is more important than immediacy.
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? You can lead a horse to water, but you can't make it drink. So it is with the consumer: make the data available, but realize it always will be, and should be, up to the individual to make a choice, even if it appears to be illogical or contrary to agency preference.
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? It should not be under the agency's purview to dictate either labels or advertising. Both are available for the consumer to judge, and both are covered under current law against false advertising. It should be up to consumers and the courts to settle these issues.
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? In a free sociaety, it is both ethically and pragmatically inappropriate to limit the use of any product as long as no harm is done to an unwilling third party thereby. Therefore the FDA should restrict its involvement in any regulatory effort to review and critiqueof available data and dissemination of information.
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? It is my view that current restrictions do considerably more harm than good, both in an empirical sense by preventing the promotion of certain products that may provide some benefit, and in an ehtical sense due to the impropriety of restricting free speech in an otherwise largely enlightened society. The alternative approach of providing information, evne if that information is that no relevant data are available, would be far more appropriate.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? I do not know the specific policies involved, but the basic principle of consumers' freedom of choice is far too emcumbered by current FDA practices. More products should be allowed on the market in all areas, including supplements, foods, and medications, provided only that they bear accurate and complete information as detailed above. The American consumer should be permitted to exercise freedom of choice without government interference.




EC -25