Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -315

Accepted - Volume 4

Comment Record
Commentor Mr. Michael Capper Date/Time 2002-09-05 00:50:54
Organization Mr. Michael Capper
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? Advertising currently raises expectations, especially among unsophisticated readers, watchers and listeners, of greater benefit from various FDA regulated products than is warranted. Trained medical professionals are better equipped to evaluate these products in a context that includes all available treatments for a particular disorder.
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? Pharmaceutical companies spend money on advertising with the expectation of increased sales that lead to increased profits. The FDA is able to include factors other than profit when regulating advertising of prescription drugs, and is thus essential in the consumer's ability to make fully informed decisions.
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? If a clain cannot be substantiated by an independent, replicable, scientific study, it should not be able to be made.
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? Better than a disclaimer, if a claim needs disclaiming it should not be allowed to be made in the first place
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? Claims should be factual, whether on a label or in an advertisement.
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? In the first place, to call advertising speech is a misleading claim itself. Speech is something an individual does, advertising is usually a corporate endeavor. Corporations blur this easy-to-make distinction in order to frighten people with the loss of their free speech if advertisers are regulated in any way. It is ludricous to refer to the FDA's ability to regulate advertising as regulating 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? Greater restrictions on corporations so-called speech are necessary to round out the education people are getting from companies that want them to buy their products. There is no incentive for these companies to give a balanced view when profit is their motive. That is why we formed the FDA to begin with.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Is the First Amendment really the governing authority here?

EC -315