Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -43

Accepted - Volume 1

Comment Record
Commentor Mr. ben simonton Date/Time 2002-05-29 06:41:49
Organization Mr. ben simonton
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? You have no right to limit free speech. Only the FTC can do that so KEEP OUT>
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? You are poisoning us with the drugs you are approving and we are by far the worst of all industrialized countries in longevity due to sole reliance on drugs rather than alternative treatments, the only ones used 60 years ago and now almost outlawed.
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? Get out of the business of evaluating claims and leave it to the FTC.
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? KEEP OUT OF THIS ARENA!!
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? DO NOT REGULATE FREE SPEECH!!
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!!
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? GET OUT OF THE FREE SPEECH BUSINESS AS YOU HAVE NO RIGHT TO BE IN IT AND HAVE PROVEN THAT YOU ARE WILLING TO TRAMPLE ON OUR RIGHTS OT FURTHER YOUR AGENDA. GET OUT!!!




EC -43