Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -136

Accepted - Volume 2

Comment Record
Commentor Mr. Ernest Bergeron Date/Time 2002-06-19 10:15:55
Organization Mr. Ernest Bergeron
Category Individual

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? No infringements on speech should ever be regulated. If historial data or research can substantiate a claim for a statement made about a dietary supplement, then it should be allowed. Compliance to FDA requirements as they exist today are absurd when years of historical and case history data can substantiate the claim.
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? In my opinion the only position the FDA has is to protect the pharmaceutical companies at all cost and not allow natural remedies on the market. Because of FDA positions physicians are not allowed to prescribe treatments for many of our ills without risk of jail. There are many natural proven cures for disease such as cancer, asthsma and diabetes with no side affects but these are taboo. Yet the FDA promotes chemo-therapy which JAMA, LANCET and other medical journals have specifically stated is not effective against cancer and even causes cancer. Who side are you on? My understanding of the law (federal) is that ANYTHING that causes cancer must be banned yet sacchrine and nutrasweet are allowed and stevia is not. It is widely know that the first two cause cancer and stevia does not. The FDA by is policies greatly inhibits adquate treatments for the people.
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? Any claims that can be proven historially or by case history should be allowed and any known side affects be listed or a place where the side affect info can be found.
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? all info except warnings should be the same size. Warnings should be in red and can be the same size of slightly larger.
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? If consumers read and followed warnings most pharmaceutical drugs would not be taken. Even doctors seldom read them.
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? as previously stated, any historical or case history data that can be substantiated should be allowed whether if fits on the label or not.
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? again historical and case history data should suffice and additional testing should not be required. PLEASE NOTE: IT IS NOT THE RESPONSIBILITY OF THE FDA TO REGULATE SPEECH. THE CONSTITUTION DOES THIS AND ITS INTERPRETATION IS THE RESPONSIBILITY OF THE JUSTICE AND LEGISLATIVE BRANCHES OF THE GOVERNMENT NOT THE EXECTUTIVE BRANCH.
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 # 7
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? ALL OF THEM. THE RIGHT OF FREE SPEECH BELONGS TO THE PEOPLE NOT THE FDA.

EC -136