Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -21

Accepted - Volume 1

Comment Record
Commentor Mr. William Hartman Date/Time 2002-05-28 20:58:11
Organization Mr. William Hartman
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? The issue is the same for both drugs and dietary supplements. In neither case it is appropriate for the FDA to ban or prevent statements that are true and not misleading. It is reasonable for the guidelines to be set as to what might consistute misleading; to specify a particular set of questions that should be answered on the package label, for example. Even then, a court should decide for the defense if following the guidelines would actually be more misleading in reality than the statement made by the manufacturer. Furthermore, such a standard should be made by law, not by administrative fiat.
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 current approach leads to over prescription because other, non-prescription approaches are discouraged by the FDA and the AMA. Advertisements by industry are protected by the need to be honest; a drug company that used misleading (but technically accurate) ads that led to death or other major side effects would be driven out of business by the lawsuits. Even Common Law handles this situation nicely. Exclusion of non-drug therapies, and therapies that are drugs but are no longer covered by patient, from equal consideration by doctors, is clearly a problem. The FDA appears to be a key part of the problem. Drugs that cannot be patiented are virtually impossible to pass FDA requirements.
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 clearly do approach claims about dietary supplements differently than conventional foods. We recognize that dierary supplements are more concentrated and can, typically, be overdosed; conventional foods generally cannot. Unfortunately, the FDA's RDA values are clearly based on the levels that prevent obvious disease, such as scurvy, rather than optimum levels. This has resulted in widespread distrust of the FDA. In many cases, it exceeds the distrust of the quacks. This problem can only be solved by a change in heart on the part of the FDA, or desolving the organization in favor of something less political and less in bed with the drug companies (for example, competing private labs, similar in concept to UL for electrical wiring).
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 that simply refer to a lack of FDA approval are unnecessary and are a clear First Amendment violation. We, the people, should not be limited to reading material which has received the approval of our government; nor should the government arbitrate or pass on the truth of our reading material.
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? We follow warnings that are clear and relate to specific circumstances. For example, do not take with alcohol; do not take more than 3 tablets in a day. Many of us would find it useful to have information as to the percentage of various side effects and the percentage who have been helped in specific ways.
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? Labels are read more carefully than ads, and tend to be believed more often.
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 of drugs are quite widespread. Any attempt by the FDA to limit these uses would result in widespread death and suffering. The FDA should focus on safety.
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 FDA's speach-related regulations are the cause of widespread distrust of the FDA, death, and suffering. As a general rule, freedom works. Let companies make true statements.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Drop all attempts to regulate speach other than setting simple guidelines. The guidelines should not have the force of law, other than the presumption that following them is the usual standard.

EC -21