Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -123

Accepted - Volume 2

Comment Record
Commentor Ms. Elaine Proti Date/Time 2002-06-12 13:18:25
Organization None
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? The FDA over reaches it's authority in way too many cases. I want the freedom to choose, I can read what you have to say but I also want to be able to know what others have to say and then make a decision. Same thing should be said to consumers as well as learned intermediaries, but perhaps in less technical way to consumer.
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? Your getting pretty legalese with some of these questions. Be more plainspoken. I understand prescription drugs are the 4th leading cause of death in this country. Something wrong with your approval system somewhere. Yes there is over-prescription of drugs in many cases. Yes they certainly increase physician visits and patient compliance with medication regimes. Perhaps they do cause visits that lead to treatment for under-diagnosed diseases. My mother had a philosopy all her life to stay away from doctors as much as possible cause they'll always find something wrong with you. She is 83 now and quite self-sufficient. No FDA's current approach, etc. does not lead to adequate treatment in many cases and actually prevents adequate treatments because the pharmaceutical industry is not involved in some of those treatments. No the understanding is not adequate with use of drugs with patients or doctors if the 4th largest cause of death is prescription drugs. Looks like the war on drugs is concentrated on the wrong drugs, but of course the war on drugs is more a control method than anything else just as the FDA is way too controlling. Yes the FDA creates all kinds of impediments to doctors who want to treat alternataively i.e. Dr. Jonathan Wright. The FDA's action in that case and many others was uncalled for and certainly doesn't reflect a free society.
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 can distinguish what they want but I also want to be able to distinguish what I may want also and not just the FDA's version because I believe the FDA is too tied into the pharmaceutical industry. They help them more than consumers.
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? Same or larger. Relevant authority could be that something has worked for hundreds of years or even less.
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? Warnings should be stated matter of factly. Not everyone can be protected from everything and that is not the govt.'s job.
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? No the govt. doesn't have greater latitude. They are subject to the first amendment like everyone else.
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? FDA has no business regulating speech that is already done in the constitution. It might undermine that new uses must be approved by the FDA, but that would be good in my opinion. Most govt. agencies need to be 'undermined' a bit.
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 they do not advance the public health, in many cases they thwart it. The only other alternative approach necessary is to just state your case but not have it be law and let people make their own choices.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? The FDA should not be law and be able to do things like they did to Dr. Jonathan Wright for example. The FDA has caused deaths of ill people by their restrictive attitude and actions.

EC -123