Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -200

Accepted - Volume 4

Comment Record
Commentor Dr. Budweiser Hawkins Date/Time 2002-07-25 23:13:55
Organization Dr. Budweiser Hawkins
Category Health Professional

Comments for FDA General
Questions
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? Adverse reactions to properly prescribed medication kill a 100,000+ people per year. We rely too heavily on medication before attempting to improve health through improved nutrition.
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? The Dietary Supplement Health and Education Act adequately addresses the issue of claims and the use of dietary supplements, nutraceuticals, etc. Claims should only be made if there is research to back it up.
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 small print as they are presently.
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? Warnings should be Capitalized and or color coded.
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? Claims made should be backed up by intelligent research.
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? Off-label uses should comply with the Dietary Supplement Health and Education Act as it stands now. Don't dilute the preambles.
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? It does not advance the public health concerns they are designed to address. The DSHEA act addresses dietary supplements and the consumers rights.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? No




EC -200