Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -277

Accepted - Volume 4

Comment Record
Commentor Mrs. Jean Galvin Date/Time 2002-07-30 00:27:16
Organization Mrs. Jean Galvin
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 think too little attention has been given to the possible benefits of dietary supplements. Also, few physicians are well versed on the benefits of proper nutrition. As a consumer, I would like to see more education and available research results in regard to dietary supplements (and alternative treatments), benefits as well as any adverse affects. I want to be able to make informed decisions about my health and what goes into my body.
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? How would the lay-person know about empirical research or relevant legal authority? Negative - direct-to-consumer advertising by drug companies undermines the role of the physician to know what is best for his/her patient, and infringes on the patient/doctor relationship. Positive - patients are made aware of possible adverse side-affects. Negative - not all drugs are available to all consumers. Do pharmacists feel there is over-prescription of drugs - how would the consumer know? I had heard this type of advertising has increased patient visits, when not controlled by managed care. I don't know the affect of this practice on treatment for under-diagnosed diseases. I would hope that doctors are not be intimidated into prescribing unnecessary drugs for their patients.
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'm not exactly sure of the first question because I'm not fully familiar with the NLEA. I would think that conventional foods and dietary supplements should have to prove the results of their claims, wlthough I'm not sure how that could be presented. Perhaps consumers could contact the supplement company about specifics.
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? Very small print is a bad idea. I am a proponent of the DSHEA.
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 am a proponent of the DSHEA.
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? I am a proponent of the DSHEA.
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? I am a proponent of the DSHEA.
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? I am a proponent of the DSHEA.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? I am a proponent of the DSHEA.

EC -277