Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -64

Accepted - Volume 1

Comment Record
Commentor Mr. William Udy Date/Time 2002-05-29 14:02:32
Organization Mr. William Udy
Category Health Professional

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? I can think of no valid argument for regulating speech, open comment or debate on any issue. Regulation only inhibits the discovery of truth. It does nothing to assist anyone who is conscious and mentally awake.
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 current FDA position seems to as a support arm for the petro-chemical pharmaceudical industry. They appear to be operating without any awareness of the fact that individual people are intellegent and have the ability to understand the desires and needs of their own body. The other obvious fact, which they are ignoring is that science, no matter how advanced it may appear does not fully understand the workings of the human body and this in itself should be enough to keep regulation of information to a bare minimum.
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? The FDA should be actively working to deseminate information from all sources, not limiting access to information one opinion of specific groups of people. This applies equally to food and dietary supliments.
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? Disclaimers are by nature misleading.
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? No-one can protect anyone from thier own stupidity and confusion is a natural human state. WE need equal representation for all theories and information, regardless of the source or methods of testing.
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? If the government feels they need to have some input in labelling, they should restrict that input to a seal of approval on labels that have been approved by them. They have no business restricting the open flow of theories and information by any other method
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 have proven that they have the ability to act outside both the letter and the intention of the law where freedom of speech and the free access to information are concerned. They need to severely curtail these habits if they wish to be considered as an organization for the betterment of the people.
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? There are always alternatives. The FDA seem to more concerned with weilding power than advancing public health.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? OF COURSE




EC -64