Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -36

Accepted - Volume 1

Comment Record
Commentor Dr. James Zeller Date/Time 2002-05-28 23:17:09
Organization Dr. James Zeller
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? It should be obvious that drugs created by chemical reactions are inherently more complex in their reactions in our bodies and thereby more dangerous. Some investigation into claims made is therefore justified. But even here the government needs to exercise caution so as to continuously build on its reputation as the defender of truth and right. When it comes to supplements it is difficult to see the government's basis for involvement. Agressive action by the government will only result in the citizen viewing the government as the propagator of corporate interests. The government should act only when the evidence for its acts are CLEAR AND PERSUASIVE.
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 whole series of questions above flow from the presumption that government should involve itself into the private lives of its citizens. The government's role is to PROTECT its citizens of CLEAR AND EVIDENT DANGERS. This is in line with fire and police functions. Doing more than that will only result in the government's language becoming just another voice. When the policeman yells STOP it should be clear to every person that they must STOP!!!! Leave all other language to other aspects of society. Government must RESTRICT ITSELF lest its communication becomes viewed as just another opinion.
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 general judgement. Get involved only when there is clear and evident DANGER TO THE CITIZEN. Grant to the states the powers claimed by the FDA. With time the states that do the best job will be emulated. The federal government is taking on too many responsibilities. With responsibility should come liability and the law is presently written so that a citizen can't sue. Be involved only when there is a CLEAR AND EVIDENT DANGER TO THE CITIZEN, and not one iota more!!
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? When the danger is evident the type should be large and unmistakable, but be sure that there is danger.
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? You create confusion and inattention when there is too much detail. Note the number of details a driver can absorb while driving. Adding too many words, words, words will only cause the citizen to regard the government as a busybody........
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? Getting involved in detail, detail, detail again!! Leave these powers to the states as the constitution directs.
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? Stay out of the business of regulation. Act only when you have PROOF OF DANGER!!!
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? The FDA like much of the Washington establishment is developing the reputation of big brother. In the end all of its good intentions will find disassociation.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? All policies should be restructured so as to find persons who CLEARLY AND EVIDENTLY have harmed others. Such persons have yelled FIRE in a crowded theater. Now ACT and not before.....

EC -36