Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -130

Accepted - Volume 2

Comment Record
Commentor Ms. Renee Votta Date/Time 2002-06-17 23:36:21
Organization Ms. Renee Votta
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? Most drugs have serious side effects whereas most dietary supplements do not in that a person normally has to take huge amounts of supplements to effect their bodies while many drugs can have immediate side effects. I believe all side effects should be listed so that people can make their own choice as to whether or not to take the drugs or supplements.
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 that because of advertising many people are led to believe that commercial drugs are ok to take and that they ask their doctors for them more often than they would if there wasn't such intense advertising. There are always advertisments in all media forms that will conclude with ask your doctor about--- leading people to assume that doctors ok these drugs, when in reality they might not.
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? Conventional foods do not have the serious side effects of drugs and therefore should not be regulated as such.
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? Disclaimers should be in the same size print.
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? State everything in clear english without large medical words that people will not understand.
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? As long as the claims can be backed up with unbiased studies I belive that freedom of speach should not be hindered.
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? If the off-label use has not been proved by independant studies then it should not be able to use the FDA approval of label uses to promote off-label uses.
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 opinion.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? No opinion.




EC -130