Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -309

Accepted - Volume 4

Comment Record
Commentor Mr. Graham Freeman Date/Time 2002-09-04 20:31:32
Organization CalTEG
Category Individual

Comments for FDA General
Questions
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 believe strongly that the FDA could sustain a position that certain promotional speech about drugs is inherently misleading. I do not think it matters who the audience of misleading speech is - whether consumers or doctors, everything deserves to be presented with complete, accurate and truthful information.
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 believe the current regulatory approach is insufficiently strong. Further, I believe that this laissez-faire approach leads to unnecessary (and in many cases unhealthy) prescriptions, doctor visits, emergency room visits, etc.
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 believe that consumers approach claims about conventional foods and dietary supplements differently. Personally, as a consumer, I assume that claims about conventional foods are usually misleading hyperbole, unless I have specifically investigated the vendor/farm/etc. in question. I have higher standards for dietary supplements, although I'm rapidly learning that I should be less trusting about those as well.
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? Disclaimers and claims should be in equal size of type and prominence.
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? Consumers tend not to read warnings in small print and with technical terms. I believe that warnings should be in an easy-to-read size and should be in plain text. Further, to avoid whitewashing by the vendor, warnings should be selected from a standard set of warnings as written by the FDA or some other theoretically unbiased entity.
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 do not believe the First Amendment was written with the intention of allowing vendors to mislead or lie to their customers.
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? I believe the benefit to the general public of FDA regulation over commercial speech outweighs any First Amendment issues. I believe that the cries of free speech by drug companies and other regulated entities are simply a smokescreen and should be disregarded.
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? Yes, the FDA's speech-related regulations advance the public health concerns they are designed to address. However, they should be made stronger.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? FDA regulations should be made more stringent, and penalties for abuse should be made more severe.




EC -309