Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -215

Accepted - Volume 4

Comment Record
Commentor Mr. Carl Kellogg Date/Time 2002-07-26 11:48:44
Organization Mr. Carl Kellogg
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? The FDA should not attempt to limit promotional speech about dietary 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? The job of the FDA is to examine new drugs that have been manufactured to determine efficacy and safety. Once that has been determined it is the job of the attending physician to determine treatment. Natural substances should be available to individuals if that is their choice for treatment. It seems rather ridiculous to regulate natural substances sold in health stores for the benefit of the drug companies.
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? consumers need to know the ingredients of their foods and supplements, but they should be able to draw their own conclusions without need for disclaimers.
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? Have the disclaimers stopped people from smoking? No!! I believe that is good evidence that disclaimers do not work to protect people from known dangers. We certainly do not need more disclaimers on natural products such as dietary supplements.
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? Again, how effective have the disclaimers been on cigarette packaging? Not effective at all in my opinion. Have warnings slowed the spread of AIDS? I dont think so. Warnings are not effective.
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? The First Amendment does not give the Government authority over labeling other than to acertain that ingredients are correctly listed.
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.
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 there should not be restrictions on speech.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? The FDA should not be regulating speech.




EC -215