Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -410

Accepted - Volume 6

Comment Record
Commentor Mrs. Christine Henriksson Date/Time 2002-09-11 19:54:25
Organization Mrs. Christine Henriksson
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? Dietary supplements pose just as much risk as other drugs for consumers, and should definitely be regulated accordingly. Weight is a growing issue with many people, and the endless battle leaves people desperate and susceptible to the promotional speeches. Add on the fact that most dietary supplements are purchased over-the-counter, which results in the consumer receiving no professional advice other than the promotional speech. Any product which alters a person's body, such as dietary supplements pose some health risk (some more than others). With all of this said, why should a supplement producer have the right to deceive people about their health?
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? I have no problem with companies advertising prescription drugs if they are providing the consumers with the truth. It can even be educational and enlightening to know about what different products are out there. What I would have a problem with is if doctors are given benefits or are encouraged to promote a specific drug based on anything other than that drug's effectiveness on patient health.
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? The best warning is the straightforward truth. An example of a bad warning is that which is put on cigarettes in the U.S.--Smoking MAY cause cancer. A good example is the warning on cigarette packets in Sweden--Smoking will kill you.
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... First, it's confusing to consumers if a company markets a product which hasn't been approved yet. Second, it overshadows (and could possibly put pressure on) the FDA approval process. Also, if they had this freedom of speech, they could tout their product as a miracle cure-all when it's only been approved for a single use. The only way I could agree with the marketing were if the advertising clearly stated that the product was in research stages and has not been approved by the FDA (and I don't mean a little label at the bottom of the ad).

EC -410