Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -364

Accepted - Volume 6

Comment Record
Commentor Mr. Paul Lehto Date/Time 2002-09-08 13:11:19
Organization Law Office of Paul R. Lehto
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 potential harm of drugs is greater than for supplements, therefore drugs should be regulated more carefully, just as a distinction has always been made between over the counter and prescription drugs. Moreover, speech to learned intermediaries provides a more equal playing field because information is less likely to have a distorting effect even though slanted by the drug company's marketing presentation because there is an ability to undertake a significant level of independent evaluation. The evidentiary basis for this is whether the intermediary employs or has access to persons with medical or academic degrees that enable them to evaluate the strength of any medical claims being made, and whether those degrees are approximately co-extensive in quality (though perhaps not in number) with the drug company's experts. As an additional basis, I do not believe corporations should possess the same constitutional rights of free speech that natural persons do, and therefore the FDA should be less concerned about violating those rights, and should make appropriate arguments to broaden the Central Hudson case. The dangers of large unaccountable corporations have become abundantly clear and they should not be free to rival the government as a permanent institution since they are not obligated in their power to respect the constitutional rights of citizens, since the Constitution is merely a limit on government, and not private, power.
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? Physicians are far too willing to prescribe what the patient requests. Therefore, drug advertising has an especially distorting effect. The positive effects of drug advertising (getting good drugs to the public, faster) can be accomplished less expensively with advertising and promotion to doctors, who are able to evaluate the claims being made.
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? I have no opinion on this particular question.
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? Yes, they should have equal prominence. The authority for this would be numerous consumer protection laws such as the Magnusson Moss Warranty act and the UCC which provide that disclaimers must be clear and conspicuous. These requirements are based on legislative findings that such conspicuousness is necessary for the disclaimer to have any real effect or meaning.
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? They can be made more effective by front-loading them in the advertising rather than having them occur after the persuasive pitch has already occurred.
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? A consumer expects a label to be particularly accurate, with accurate listings of dosages and ingredients. Consumers are more on guard as to information in advertising. The First Amendments requirement that commercial speech be not misleading or deceptive therefore applies with greater force as to labels, where it is more likely to be misleading since trust levels are higher on labels than on advertising.
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? Yes. FDA approval is only for the applications contemplated and no approval can be implied for uses that have not been studied since such uses may in fact be dangerous.
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? Yes.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Being cognizant of applicable case law limitations, the FDA should go further and in particular recognize that individuals should have constitutional rights of speech and not corporations. In other words, while some protection of corporate speech has been recognized, those rights should be strictly construed against the corporations, which did not really exist in anything like the present form at the time the First Amendment was adopted. Thomas Jefferson and Abraham Lincoln both warned against the tyranny of the corporation if they are thought of as having rights equal to or greater than individuals or the public generally.

EC -364