Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -120

Accepted - Volume 2

Comment Record
Commentor Mr. Gerald Wolke Date/Time 2002-06-10 13:19:14
Organization Mr. Gerald Wolke
Category Health Professional

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. Free speech is just that. It isn't up to you to decide what is misleading. There are no standards for that. Nor does education matter.The founding fathers correctly determined that having a government authority decide what is correct, whether politically or commercially,is the abolition of free speech and tyranny. They also realized that in a free exchange of information, so-called misleading speech would be countered by different and even opposing opinions. Despite court opinions against you, you are still breaking the fundamental law of the land. Shame on you.
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? Again, this is not your problem. In this information age, people can access information at will. They are not children and don't need keepers. Instead of breaking the law you should trust the people to create their own solutions.As Herbert Spencer put it, to protect people from their follies is to create a society of fools. Without the false belief that the FDA knows the absolute facts, when in fact it is trafficking in biased opinions often promulgated by so-called experts with ties to the drug industry, people will establish other sources of information. The continuing practice of squashing free speech merely prevents the free flow of information and innovation.
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? No. You still don't get it. If you are still looking for a loophole to justify your existence this isn't it. The mere asking of a question like that last one is not knowable and arrogance beyond belief. If you intend to establish your bureaucratic regulations by attempting to establish human behavior patterns by poll, you are more pathetic than I thought.
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? Get serious.
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? Again,you are asking for info for which there are no answers, except opinions.
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, which you obviously don't understand, does not afford the government anything. It reminds the people that they are free to discuss, to argue, to promulgate and to promote.
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? Should you squelch innovation and contrary opinion? No.
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. You are breaking the law and a few court orders. I demand, as a free citizen, that you desist immediately.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Prohibit out and out lies. If someone says, This product cured my uncle, that may or may not be true. We know that. If someone cites research that has been deliberately falsified, that is grounds for government action. Period.It is time for the FDA to quit the oppression business, to stop gestapo-like raids,to quit harrassing the American public,to stop enforcing your opinions against everyone elses,and to pretend you are protecting the public when as your former commissioner, Kessler, said, your business is to guarantee profits to the drug companies. BTW, I am a pharmacist so I know something about drugs.

EC -120