Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -159

Accepted - Volume 4

Comment Record
Commentor Dr. Robert Lookabaugh Date/Time 2002-07-25 09:43:20
Organization Dr. Robert Lookabaugh
Category Health Professional

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? Speech regulating speech concerning drugs should be more comprehensive that that concerning dietary supplements. The DSHEA legislation provides for that and should not be weakened.
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? Advertisement of pharmaceutical agents is persuading consumers to demand such agents from health care professionals, and in many cases leads to excessive use of such products. Consumers are not aware of the potential risks of the use of drugs, and tend to overlook them. Further, with the use of numerous drugs contemporaneously assessment of the potential drug interactions is often impossible.
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? Dietary supplements should be controlled by DSHEA, and labeling claims of health benefits for dietary supplements should be further expanded. Example, there should be no restriction on a label for Vitamin C that claims it prevents and cures scurvy.
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 type size and prominence with claims. I know of no research or social science, but it simply makes sense.
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? Harm caused by dietary supplements is extemely rare in comparison with harm caused by pharmaceutical agents.
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 argument is simple - that if the claims made in advertisements are more expansive they may be less than factual.
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? Physicians should be able to prescribe pharmaceutical agents for off-label uses on an individual basis, taking into the unique characteristics and requirements of every human being.
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 comment
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? The FDA should make no efforts to reduce the impact of or change the substance of DSHEA, except to allow broader claims for nutritional substances to prevent or cure disease, if supported by reliable research.

EC -159