Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -387

Accepted - Volume 6

Comment Record
Commentor Mr. Ryan Scott Date/Time 2002-09-10 18:21:58
Organization Mr. Ryan Scott
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 think regulating advertising about drugs is crucial because corporations shouldn't have a constitutional right to commercial speech. The First Amendment was intended to be their for people, including those who work for or buy stock in these corporations. People should have the constitutional rights, not corporations. I think the FDA could sustain a position that promotional speech of a commercial nature by corporations is not protected under the First Amendment. People, not corporations, should have constitutuional protections.
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? DTC advertising should be prohibited by the FDA. Drug companies spend more money on the advertising than Pepsi or Budweiser does. The ads encourage consumer to demand and get doctors to prescribe drugs they do not need. The ads also fail to provide comparative beenfits of the marketed drugs to alternatives, or revelal price information. The positive effects I think, are mostly for the profits of the big pharmaceutical companies, not anybody else. It does lead to over-perdscription to drugs. I don't know about patients visiting for treatment for under-diagnosed diseases.
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 think that genetically modified foods should be labeled, in order to give the consumer the right to decide whether or not to buy and/or consume them. Perhaps the FDA wouldn't have to make it mandatory, but if that is required, I would support it. I think labeling information can best be presented when it is clear.
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? Yes, I think so. Because people need to be able to read it.
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.
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? No, I don't think so. Because labels have to have some kind of validity.
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, I think the FDA should regulate it all.
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? Restrictions on the constitutional right to corporations having commercial speech is the issue here. People need to have the ability to dissent and protest, but not corporations to hawk their wares.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? You should encourage or make it mandatory for labeling on genetically modified foods, because the consumer has a right to know. It is a basic right, much more important than a food manufacturer. You should ban tobacco ads and promotions.

EC -387