Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -275

Accepted - Volume 4

Comment Record
Commentor Mrs. Sheila Reetz Date/Time 2002-07-29 21:34:49
Organization Mrs. Sheila Reetz
Category Dietary Supplement Industry

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? Drugs are by definition toxic substances. Dietary supplements are by definition non-toxic substances (food). I can't believe you are asking this question. If you are looking for inherently misleading statements, watch the tv commercial about the purple pill you can get from your dr.
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 FDA's current approach does not allow scientifically known health benefits of dietary supplements (ie: vitamin C prevents scurvy) to be used or made known. Obviously this affects the ability of doctors to give optimal medical advice and prescribe treatment.
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? I don't know of any research on this issue. I would think the same size type should be used...equal prominence.
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? When warnings are delivered in a low monotone following a bright, happy up-beat commercial touting miracle cures, they are disregarded.
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? Good heavens...your authority DOES end, you know. It isn't limitless...and we, the public, do have a brain and are able to make our own judgements.
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? Scientifically proven health benefits should be allowed to be displayed on labels.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? People are not total ignoramuses (lol!). When our freedoms are curtailed, 'for our own good', no good results. Today this country has at our fingertips any and all informations, we are the most educated generation ever. We must be allowed to choose for ourselves our preferences, especially as regards non-toxic supplements. Food... good heavens, if the gov't thinks it can choose our foods for us, we are in deep shit.




EC -275