Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -56

Accepted - Volume 1

Comment Record
Commentor Ms. Jeanine Lane Date/Time 2002-05-29 11:23:46
Organization Ms. Jeanine Lane
Category Individual

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? The FDA oversteps it bounds with its current policies. FDA should concern itself with DRUGS as it was intended to do. IT should not bow to the demands of the drug industry to try and tell us how to deal with our own particular situations.
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 FDAs position only is for the benefit of the drug companies and interferes with our constitutional rights to decide for ourselves what is in our best interest. The drug companies do not care about anything except their bottom line.The current regulatory approach certainly leads to over-prescription of drugs.
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? They shouldn't. Our food sources are so deplete of nutrition that the aware consumer knows he has to supplement. Food labels should only list ingredients.
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? The same, I guess.
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? More harm is done with prescription drugs than with supplements. I can't speak for all consumers, but I research whatever I take.
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? Ifthe drug companies advertising on TV is allowed, then manufacturers of supplements should have the same rights.No, the first Amendment should be respected.
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 is supposed to deal with protecting consumers from in-effective drugs. Many dangerous drugs have been approved as demanded by drug companies, with no regard for the consumer.
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 don't. Just stick to the duties FDA was formed to handle.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? FDA should have no authority to ban non-drug supplements that the consumer chooses to use. It is up to the individual to make that determination - we are a free society, are we not?




EC -56