Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -411

Accepted - Volume 6

Comment Record
Commentor Ms. Lynn Godtfring Date/Time 2002-09-12 10:09:34
Organization Widener School of Law
Category Academic

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? Drugs and dietary supplememnts should be regulated in the same manner given that either one can have a profound effect on the human body. The language contained within these regulations should be written on an elementary level so that the average consumer has the ability to understand these effects and make an informed dscision given all of the 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? Advertising does have a direct effect on the number of physician visits and raises the patients level of communication with physicians to a higher level. While this is not necessarily a negative effect - physicians need to guard against patients direct request for medications. This in turn should not have an impact on a pharmaceuticals company's right to advertise.More information is better than less - it should be up to the prescribing physician to make the final call.
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? The general public sees food as dietary as opposed to viewing supplements as curative; therefore, the advertising for supplements should be stronger because of their general purpose in the society's view. The best way to present any information is in a truthful and not misleading fashion. A perfect example of this is the advertising made on low fat foods as compared to their regular fatty counterparts - the difference in fat content is such a small amount but it leads the public to believe there is a great benefit in eating the lower fat version.
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 should be required in at least the same size print if not larger print with very distinguishable features, to catch the eye of the consumer.In addition, the hazards of using a particular product should be given equal prominence, if not greater prominence, than the benefits of a particualr product.
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? Warnings should be truthful, as forthright of potential side-effects, common misuese, etc. Again, they should be written on an elementary level - 5th grade or less.
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 distinguishments should be made, they should be regulated the same. The First Amendment does not give any greater latitude to the Government to regulate one greater than the other.

EC -411