Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -48

Accepted - Volume 1

Comment Record
Commentor Mrs. Mavis B. Elks Date/Time 2002-05-29 08:57:08
Organization Retired R.N.
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? We look to the FDA to research and approve life saving drugs; and many are not completely safe for some people, bad reactions. Medicine is not perfect. But vitamin supplements are essential to supplement our modern day processed foods. The FDA statement on supplements means nothing to me. Each individual is educated enough to know how they eat and what is necessary in their diet. I see the same scenario in labeling brocolii, cauliflower, tomatoes, etc. Are you going to waste tax moneys to test every product produced and grown in the world? Thank you.
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? Patients should advise doctors of the supplements they are taking and most doctors can evaluate if there is a conflict with any prescription drug.
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? No
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
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? Consumers look to the ingredients list for something they may be allergic or sensitive to and don't buy it.
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. This is a free state and BUYER BEWARE society.
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? None.
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? They are aware of many, they just don't use them because it would effect the almighty dollar.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? No labels but continued testing. In many cases a drug is released with approval only to find down the road that it is not safe or is carcinogenic.




EC -48