Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -151

Accepted - Volume 2

Comment Record
Commentor Ms. Rosemary Adams Date/Time 2002-07-15 19:51:24
Organization Ms. Rosemary Adams
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? Drug companies seem to be getting more and more aggressive in pushing new, expensive drugs, when older, cheaper, and even generic drugs may be just as useful and possibly safer. There is also a culture that demands a drug for every discomfort, and physicians feed this culture by automatically prescribing or handing out samples of the latest drugs to every patient. While it is useful for people to know about drugs and what they can do, they should also know about the limitations and dangers of drugs, the alternatives they could pursue instead of resorting to drugs. For this both the public and the medical profession need a lot of education. Perhaps the FDA could play a role in opening up discussion of the subject in medical schools and the media.
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? A little knowledge is a dangerous thing. If companies want to tout the benefits of their drugs and devices (whether to the public or to physicians) they should be required to give equal emphasis to contraindications, known side effects, possible new side effects, and alternative treatments.
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? Labeling of conventional foods and nutritional supplements alike should be complete, i.e. no secret ingredients, nor misleading code words such as natural flavors (meaning MSG, which is neither natural nor a flavor when added to foods and can be very harmful to some people). Food labels should not attempt to specify ideal quantities of various ingredients to be eaten daily, since this varies with the individual.
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? All type should be readable without magnification by people with normal or corrected vision, and disclaimers should be the same size as other information.
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? Print warnings prominently on the label, using plain language. Specify, whenever possible, why the warning is given (i.e., what might happen if you disregard it, not because the government requires it!), because people are more likely to disregard vague warnings they don't understand.
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? Information on labels should be limited to facts. Advertising belongs in the media.
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, information about possible uses of a product belongs in media where the issues can be (and must be) fully disclosed and discussed in depth. FDA does not necessarily know and cannot necessarily prove the safety and efficacy of every substance for every person. People must inform themselves and consult with qualified nutritionists (not physicians, who seldom know much about nutrition beyond the 1950s Food Pyramid) when in doubt.
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 government's role is to protect people from other, unscrupulous people, not to tell people how to run their lives. Therefore, the FDA should ensure that products on the market are accurately labeled, i.e. they contain what is listed on the label, in the specified quantity and strength, and nothing else. Beyond that, it is up to the individual to decide, even through trial and error, what is best for his or her particular situation.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? It would be helpful to people interested in herbs and other nutritional supplements to allow a brief listing of the usual uses of the substance on the label. Exaggerated claims and guarantees (other than money back if not satisfied) should not be allowed, since no one knows exactly how a given individual will react to any product. This fact should also be mentioned.

EC -151