Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -207

Accepted - Volume 4

Comment Record
Commentor Mr. Peter Stephens Date/Time 2002-07-26 08:16:26
Organization World health & Wellness Network
Category Dietary Supplement Industry

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? The audacity that any government and especially the government of the people, by the people, and for the people could consider any constraint on speech other than for national security concerns is astounding. Let the people decide with proper information whether something is good for them. Stop trying to be Big Brother.
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 present approach leads to a lopsided influence for advertised drugs versus physisians ability to make correct choices. It should be stopped.
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? Given independant data that substantiates benefit claims that out weigh the lack of dileterious data, health references should be allowed on dietary substances, providing they are more than anecdotal. Anecdotal claims should be stated as such.
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? Discaimers should be of a size that can be read with out a magnifying glass.
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 in red, cautions should be in black.
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? 1st. Social science is not a science and 2nd. The government should not make distinctions of 1st amendment issues when it relates to the publics right to know. The court does that.
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? The FDA can and should not be a policeman when it comes to legelly pursued commerce. The dietary act of 1994 lets consummers be educated and informed. With dietary substances and the internet education is easy to obtain for the public.
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. Yes, as outlined above in #3.




EC -207