Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -434

Accepted - Volume 6

Comment Record
Commentor Ms. Claire Garden Date/Time 2002-09-17 13:56:56
Organization Ms. Claire Garden
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? I don't think corporations should have first amendment rights at all. Corporations should not be considered persons. Yes, there certainly is good reason to regulate speech (advertising) about drugs of all kinds, including nicotine and alcohol.
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 don't know how thoroughly the FDA regulates advertisements other than it's supposed to be truthful and make no unjustified claims. I do NOT like the way prescription drugs are marketed to doctors (for example, HRT). Doctors are being rewarded by pharmaceuticals for prescribing and advocating their drugs. This is very bad for patients.
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? I WANT my food labeled as organic and not having modified genes and I want these labels to be reliable at the CA level of standards. I'm fine with having to read elsewhere about the efficacy of herbs for health benefits, but I do want herbs to be available at affordable prices.
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? Same size of type would be good.
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? I don't know. I read labels and pay attention myself.
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? Again, I don't think corporations should be given First Amendment protections. They should not be considered persons and that court ruling in the nineteenth century should be reversed. Both labels and ads should be truthful.
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? If science writers or any other persons want to write books and articles about studies or experience showing the efficacy of herbs or drugs, they have First Amendment protection. I don't want the same protection given to corporations.
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? Go ahead and restrict the speech of corporations to the truth. And restrict their speech so that they are not allowed to market nicotine and other harmful products to children.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Yes, change the law or seek a new court ruling so that corporations are not given equal protection before the law as if they were persons. They are not persons and should NOT have those rights.

EC -434