Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -433

Accepted - Volume 6

Comment Record
Commentor Ms. Martha Hall Date/Time 2002-09-16 15:53:09
Organization Retired
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? I believe there are fundamental, across-the-board arguments for regulating _all_ commercial advertising. Although I am concerned about truth in advertising of drugs and dietary supplements these are not my only concerns.
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? Although I list myself as a retired academic I have considerable professional background in the medical field. I do believe there are some advantageous effects from advertisement in this field but in today's world of increasing advertisement blitz and implicit brainwashing I am very much concerned about actual product-related dangers as well as the implicit/potential encouragement to consumers to spend money foolishly/or and with inadequate information. The implicit thrust in advertising is to get people to spend money. Despite the general belief that consumer spending is necessary for economic health, in the case of advertising-influenced choices, often this encourages spending that contradicts both the wellbeing of the individual spender and of the overall health of our society's economy.
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? It seems to me the FDA not only may but must distinguish claims concerning conventional foods from those relating to dietary supplements. Claims should be sustained or denied on the basis of responsible and adequate test procedures and reporting procedures on the part of those wishing to make the claims.
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? Probably the fairest approach is that disclaimers be in the same size type as claims. I don't know the answer to your second question, and if you find out, I'd like to!
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? a. Not sure. b. 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? I'm going to have to think about this one.
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 believe that leniency about off-label advertising undercuts the effectiveness of FDA product approval. As for your final question, you tell me!
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? This set of questions needs several sessions of discussion, in my opinion.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? By and large I feel that in today's increasingly media-defined culture and its fiscal dependence on advertising, advertising is corrupting both mental and fiscal health in general, and is particularly dangerous to the young. I believe the body politic is increasingly in need of protection against the power of corporate monies to try to mold its choices and ability to assess whether or not it is truly informed. Ongoing legal requirements for making public knowledge the size of investments in, and, where possible, profits from advertising is very helpful in this. Of course strictly speaking that is not in the purview of the FDA but awareness of how much potentially manipulative power and ability to avoid full disclosure adheres in our current culture to corporate advertising, seems to me must be taken seriously into account in current FDA decisions affecting the legal status of First Amendment interpretations of status and regulatory requirements of corporate advertisings.

EC -433