Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -42

Accepted - Volume 1

Comment Record
Commentor Mr. scott brians Date/Time 2002-05-29 02:03:01
Organization brians & partner
Category International

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? There are no arguments to promote this regulation at all. The burden of proof lies with the FDA to determine that a producer has lied. Any manufacturer has the right to claim what he wants, without permission from any organization. When the manufacturer has found to have lied, he is taken to court by those who have been injured.
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 organization (along with its regulatory approach) demotes the level of Health Care in the USA.
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? Only an English teacher could determine whether a particular sort of language were misleading. Never the FDA. The FDA is inherently misleading.
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 any size the producer chooses.
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 givven in any form the producer chooses.
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 gives the Government no right whatsoever over advertisements or labels.
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? Undermining the FDA is exactly the point. The act does undermine the FDA, and this is positive for America. The FDA can only legally attack a manufacturer after the label / advertisement has been made and proven to be false.
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? FDA regulation does not advance the public health concerns, but rather regresses it. The last question is answered above.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Previous to advertisement, the government has no right to bar the contents of the adverisement - but only after it (the advertisement) is made public and proven to be false. And in this case, the FDA should represent those injured, and not government. The FDA can only act when a civilian requests action against a specific advertisement, never before.

EC -42