Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -371

Accepted - Volume 6

Comment Record
Commentor Mr. Jeff Nale Date/Time 2002-09-09 14:29:05
Organization Mr. Jeff Nale
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? Consumers should always be the first consideration. Even at the expense of a corporation or government agency, the consumer should come first.
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? Drug promotion should be left up to a health care representative, primarily a physician. The requirement to list side-effects during advertisements is an excellent idea. It should be expanded to be listed by voice and visible text in the advertsiement.
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 should not be limitations on claims that can be made about foods or foods. All consumables should be scrutinized intensely, be it crackers or ephedrine supplements. Consumers would approach foods and supplements the same if supplements were easier to investigate. Supplement labels read like a legal contract. There should be clear warnings and risks. Further, foods should also be easier to read. The current FDA Nutritional label is a step in the right direction, but most consumers do not know how to make sense of much of the information. For example, caffeine is not generally seen as the stimulant that it is, but it should be. Most consumers would tell you that chocolate can make you fat, but do not see sodas that are full of sugar as having the same capability. I do not know if this is the FDA's role to make warnings about such things, but it should at least be considered.
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 should mirror the warnings on cigarettes.
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? Some sort of rating system may be effective, but highly controversial. Products should be allowed to offer confirmed benefits alongside warnings.
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? If the FDA is willing to offer insight that the manufacturers are not, then great latitude should be afforded. Unbiased information should be the goal.
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? Again, the consumer should come first. Corporations are not individuals. The should not be afforded carte blanche to free speech. Unlike most individuals, corporations have the funds to push their speech on the public, not just express it. It should be highly srutinized and regulated by the FDA for the benefit of the public.
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? I do not believe fewer restrictions is the answer. Incentives for corporations might be the key, but not in the form of a corporate hand-out. The FDA might consider a more involved role with the public, be it public service announcements or some other interaction.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? I think a mission statement reflecting the consumer first, corporations second ideology should be evident to the FDA and the public.

EC -371