Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -300

Accepted - Volume 4

Comment Record
Commentor Ms. Janet Kritser Date/Time 2002-07-31 02:10:54
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? There is no comparison between drugs and dietary supplements with regards to toxic and/or lethal abilities. Although some herbs have toxic qualities, overdoses are seldom heard of--and never have I heard of a mix-up of herbs causing death. You must sustain a position of curtailing pharmaceutical cos being able to promise taking their drugs will enhance life quality. I saw 37 instances of full-page ads by drug cos. in a recent issue of a well-known weekly magazine--and people will believe anything they read if they are uneducated regarding deceitful advertising. Drug cos shouldn't be allowed to advertise directly to the consumer, who is never able to evaluate whether the statements are true/false or otherwise.
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? Don't know. The negative is the drug cos will make tons more money than they're already making because people will believe their claims promoted in the media. Yes, drugs are over-prescribed. The FDA's approach/implementation by industry doesn't seem to affect treatment at all. It also does not affect patient understanding of potential risks associated with drug use. No, the FDA's approach doesn't create any impediment to drs advice/treatment--drs don't generally take enough time to discuss treatment whys and wherefores or give patients alternatives period. Which is tied into their perks from the drug cos and their unwillingness to spend sufficient time in explanation, which would cost them money.
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? FDA needs to regulate dietary supplement cos so that a standardized content can be established and controlled. I've read testing results using products from a number of different companies in which there was little correlation between what the label said and what the bottle contained. Any claims by these companies are in no way potentially as damaging as those claims by the drug companies, whose toxic chemicals cause untold side effects besides masking the health problem--never curing it, as I see it. Most consumers are so ignorant that it takes very little for them to be misled--they mostly don't know how to interpret the information they read to begin with and are too lazy or too disinterested to investigate claims for various supplements--which is easy to do. I doubt that consumers approach claims re the two categories any differently, being consumers being notoriously indifferent to begin with. They like to be led and take the easy path, which primes them for gullibility in case there is subterfuge going on.
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? It doesn't matter. People pay little attention to disclaimers, barring previous unpleasant experiences that may have made them wiser.
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? Require clear, concise wording--no obfuscation or double-speak.
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 would think the government has the ability to control the propensity of industry to skate the outer limits of acceptable promises just to sell to the unwary.
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? Why would the FDA presume to try to control off-label uses of anything? Particularly where foods and health supplements are concerned. We are not speaking of narcotics here. I do not believe the FDA has the ability or the right to regulate any speech regarding off-label usage.
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? No. Yes.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Give up trying to regulate health products that cause no harm--that is the first admonition in a doctor's creed, most of whom do not seem to follow that, and none of the drug companies seem to care whether they follow or not.

EC -300