Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -274

Accepted - Volume 4

Comment Record
Commentor Mr. Eldon Larson Date/Time 2002-07-29 20:11:30
Organization Mr. Eldon Larson
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's charter is to assure the safe production and application of toxic medical drugs. An FDA position to restrict or disallow factual, non-misleading, labeling of nontoxic products, which support healing negates congress's mandate to allow the factual (plain English) labeling outlined by the Dietary Supplement Health Eductaion Act (DSHEA).
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's current postiton regarding direct-to-cusumer and other advertising of DSHEA qualified non-toxic healing support products includes a frivolus consummer-spooky disclaimer and even prohibits specific truthful imperical language, which is inconsistent with imperical research.
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 DSHEA established a clear distinction between conventional foods and clinically effective nutrients by directing the FDA to create a new drug-exempt classification for non-toxic substances, which demonstrate clinical healing support.
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? Except for scaring consummers away, disclaimers for non-toxic clinically effective nutrients serve no useful purpose.
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? Save the punch for legitimate warnings by eliminating frivolus rubber-stamp disclaimers.
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? Whereas the First Amendment is in a freedom of expression arena and factual product labeling is in a safety regulation arena the last question is crosswired (not applicable).
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, the FDA's charter is to assure consummer safety. Products qualified as Drug Exempt under the DSHEA are inherently safe. Thus, the last question about regulating speech is no more applicable than the previous section's last question.
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? The answer to the first question is no. Yes, stick to the simple non-misleading efficacy statements manadated by the DSHEA.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Since the DSHEA's requirement for factual non-misleading product labeling regulation is allready in place, one must wonder why such a simple matter is being subjugated to expression surpression.




EC -274