Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -106

Accepted - Volume 2

Comment Record
Commentor Dr. Robert Arbon Date/Time 2002-06-03 11:00:44
Organization Dr. Robert Arbon
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? Nearly all of the questions proposed avoid the point that the consumer is the final judge. The job of the FDA should be to empower him to come to an informed decision for himself. The job of the FDA would be to insure that he has the opportunity to access all of the information. At the least the FDA could provide several independent opposing scientific summaries concerning a product, pharmacutical, suppliment, instrument or otherwise so that the consumer could decide for himself.
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? Presently direct prescription drug advertizement does not give all of the negative potential results. Again in my opinion the best answer would be to make the consumer responsible but make certain he is advised that there are other views and where he can easily find that information.
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 FDA should see that foods and products actually contain the advertized levels of the benificial ingrediants. Again pro and con information must be furnished for the consumer to draw his own conclusion.
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 consumer is responsible for his choice with adequate information to assist him. False information, advertizing or ill effects arising from the use of the product could then be independently pursued in the courts by the injured person.
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? See #4
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? See #4
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? See #4
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? See #1 & #4
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? See #1 & #4




EC -106