Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -143

Accepted - Volume 2

Comment Record
Commentor Mr. Wayne Gorsek Date/Time 2002-06-30 18:28:29
Organization Mr. Wayne Gorsek
Category Dietary Supplement Industry

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? Yes, drugs require higher levels of regulations when compared to dietary supplements. In 1996 a article published in JAMA indicated that over 100,000 Americans die each year from the side effects of drugs and millions more are hospitlized. Data indicates that very few Americans die from dietary supplements (less that 50 per year).
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 should require that drug companies track side effects of drugs and report them to doctors and consumers with all promotional materials. The most recent example of the need for this is the COX-2 inhibitors, drug companies covered up their side effects and made billions falsely promoting them as safer the other NSAIDs.
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? The health benefits of foods and dietary supplements should be allowed on advertising materials, websites and labels. If this statements are false, the FTC has the ability to sue the offending company and gain injunctions and other relief. The FDA should not restrict speech and should not be involved unless a product is found to be dangerous based on reported deaths and/or injuries.
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? Disclaimers should be allowed in smaller size as they are in many other industries.
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? Warnings should be required where there is a known risk of death or injury. This really relates to drugs and not dietary supplements.
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 First Amendment protects speech on both labels and advertising. If it is the truth a company has the constitutional right to say it on the label, in ads, on websites, etc.
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? NO, if the FDA approves a drug, that drug should be safe and the benefits should outweigh any known risks. Unfortunately the FDA approves many drugs that are not safe and have no proven benefits in reducing death rates, disease rates or reversing disease.
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, the FTC has the responsibility of stopping companies from defrauding the consumer. The FDA should not stop companies from exercising their first amendment rights, period. If 100 claims are made and 1 turns out to be false, the FTC can stop the 1 false one. The other 99 should not be prevented.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? The FDA should allow dietary supplement companies to make health claims on product labels and in product advertising.

EC -143