Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -409

Accepted - Volume 6

Comment Record
Commentor Mr. Kristoffer Henriksson Date/Time 2002-09-11 19:42:54
Organization None
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? If consumers cannot trust pharmaceutical companies to tell the truth, why choose real drugs over homeopathic treatments or none at all?
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 think it's clear that advertising does make people take drugs they would not normally take before. Whether this is a good thing is debatable. I would lean towards it being a bad thing, with doctors prescribing unnecessary medication. For example, witness the recent rise in Attention Deficit Disorder and the associated rise in children taking drugs.
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? Any deviation from normal side effects (nausea, vomiting etc) that occurs in larger frequencies than sugar pill should be given the same prominence as the claims. One cannot make an informed decision simply by reading the claims and not the side effects. Most Americans will not read tiny print, being conditioned from birth to ignore such warnings.
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. They are directly side-stepping the FDA approval process. If it were not regulated I could sell aspirin and claim that it on the side makes you live longer, have a healthier life, and grow a 12 inch penis (if you're a man) and I'd have an instant best-seller with no recourse from the FDA. Such a situation would hardly be ideal.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Plain and simple, corporations should not have first amendment rights to the degree that they can trick American consumers. There is an inherent trust between a buyer and a seller and it would be irrevokably damaged should the seller be allowed to make claims that have not been verified.

EC -409