Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -317

Accepted - Volume 4

Comment Record
Commentor Mr. Jeff Donner Date/Time 2002-09-05 01:29:11
Organization Mr. Jeff Donner
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? Yes; dietary supplements aren't backed by anyone, they could be any hooey, and people hopefully know that. Drugs claims are stronger & taken more seriously, & thus more comprehensively regulated. I think promotional ads about drugs could be subtly misleading, and so should comply, yes. As to 'turning on who its pitched to' I suppose it might, but really I think ads should be limited to information only, like, study results, anyway. I don't know any evidentiary basis, but, advertising that isn't simple information is meant to skew opinion anyway.
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? First question, dunno. Second, negative effects are that consumers push doctors to prescribe stuff that they don't really need or that is more expensive than necessary, raising, unnecessarily, the costs of health care. So, I dislike the current rules about ads. The 'good' they do is to the advertisers, not the 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? People hopefully know that with dietary supplements, anything goes. Regulation of claims on food is helpful, because people trust the labelling more, and *must* have food. I would say though that food might make speculative claims, as long as it is qualified that that's what the claims are.
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? I like the idea that claims and disclaimers should be the same size. You might tie the size of the claim to its certainty, perhaps.
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? Pictures, symbols, would be good, so people could search for them quickly, on an item.
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? I guess what's on the label should be authoritative, should be only strongly supported claims, especially since they're controlled by the FDA, which people mostly trust. I would actually prefer that ads consist of well supported claims, and if there's any weakly supported stuff, it should be clearly prefaced as such.
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, off-label use would undermine the law's requirement, because it would be allowing marketers to make a claim that hasn't been backed up according to the usual FDA standards. Even if the drug does no harm in the right circumstances, I think there should be some confirmation of the effect advertised, or at least, definitely on the label.
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? Speech is very powerful; people trust, in large part, what they hear. I think in important things like drug advertising, claims should be strongly backed up, or clearly qualified.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? I don't believe in first amendment rights for corporations. They are not alive, they do not share the burdens or the characteristics that humans have. I think the public interest trumps, all the way, any corporate 'right' to free speech.

EC -317