Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -18

Accepted - Volume 1

Comment Record
Commentor Ms. Beverly Nadelman Date/Time 2002-05-28 20:46:51
Organization Ms. Beverly Nadelman
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? Yes. It is in the interest of drug companies to market directly to the consumer and get them to request specific drugs of physicians. Frequently they will shop for a doctor willing to recommend them if the first one they consult feels they are inappropriate for the particular individual because of potential side effects or for other reasons. If the speech is made to medical professionals, one can only hope they do their homework thoroughly, though we know all too many doctors depend on drug company detail men for their information. Marketing directly to patients, such as being done on television, is a disaster.
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? I do belive there is over perscription of drugs and under dependence on various natural means to addresss the same problems as drugs address when either is appropriate.
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? I would not include prohibitions on information concerning food, vitamin or herbal based claims, though I would approve a disclaimer advising the purchaser to investigate conditions that would mitigate against taking them or taking them in non recommended doses.
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? Yes. Most people regard small type information as either not important or not addressed to the average user, and many simply can't see it to read it.
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? Develop standards for specific warnings similar to the skull and crossbones used for poisons.
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? First amendments rights are exactly that regardless of where they are used. The FDA has been violating them for far too long.
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? No. Most of the uses in question are not new-at least for vitamins, natural food supplements and herbal preparations.
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 block them when it comes to preventative care and general wellness.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? The FDA should not serve the drug companies by getting in the way of natural remedies.




EC -18