Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -109

Accepted - Volume 2

Comment Record
Commentor Dr. Karl Blasius Date/Time 2002-06-03 21:50:26
Organization self
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? Drugs which are not naturally occurring substances within the parts of the body where they are administered may be required to have stronger evidence of dose level safety/hazzard in order to receive FDA approvel.
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 FDA currently under performs in the area of urging caution, self-education, and preference for the use of the most benign potential treatments. For example, the use of time-tested dietary changes and herbal treatments should generally be considered before introducing a newly invented medicine.
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? There is no legitimate distinction to be drawn between foods and dietary supplements. Claims should offer summaries and references to studies of substance effects. Useful distinctions could be made between manufacturer-sponsored research and independent research and between simple research reports and peer-reviewed research reports.
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? Don't try to design entire labels other than to set a minimum type size for legibility and perhaps a standard symbol and color scheme for warnings.
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? A standard symbol and color scheme for warnings or contraindications would simplify self education by consumers and physicians.
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? No distinction. The 1st Ammendment does not allow such an arbitrary division of commercial speech. Social science is not relevant here.
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? FDA has no right to inhibit truthful information flow in commercial speech.
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? FDA's limitations on speech have encouraged ignorant risk taking, backed-up by litigation, rather than informed choice. The FDA should agressively promote self education by consumers and physicians and informed choice of therapy and assumption of risk.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Stop trying police all the details of technical commercial speech. Spend more resources on monitoring foods and medicines for adulteration and failures of dose standardization, particularly for substances with high toxicity at near recommended doses.

EC -109