Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -163

Accepted - Volume 4

Comment Record
Commentor Mrs. Linda Clark Date/Time 2002-07-25 11:48:53
Organization Mrs. Linda Clark
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? I would not be in favor of changing the policy regarding claims about dietary supplements. The DSHEA act is regulation enough.
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 believe the pharmaceutical industry should not be allowed to market their new expensive drugs directly to consumers. It seems that this technique pads the pockets of the drug companies and fills the medicine cabinets of an uneducated public with oft-times unnecessary - and potentially harmful - medicines.
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? If the dietary supplements are made from foods, the FDA should not distinguish claims concering the supplements from those claims that can be made about foods. If qualified research has shown a relationship between a food and its effect on a particular condition, that claim should be allowed on the labeling of the dietary supplement.
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 disclaimers should be included in the labeling, but the type could be smaller.
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? I personally find bold type inside a box effective as a warning.
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? Advertisements should portray a result that is seen by the majority of patients - not the lucky few - and unpleasant or dangerous side effects should be given a more prominent placement in the advertisements.
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. Off label use of products has been effective for years and many conditions have been mitigated by observant physicians who have prescribed drugs in this manner. I do think it is only ethical for the doctor to tell the patient that he is prescribing for a use that has not been tested.
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? Some of the speech regulations are too restrictive and they impinge on our first amendment rights.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Speech-related regulations should be relaxed.

EC -163