Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -324

Accepted - Volume 4

Comment Record
Commentor Mr. craig clark Date/Time 2002-09-05 10:02:34
Organization Mr. craig clark
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? Although the FDA does not currently have jurisdiction over tobacco, there are many proposals to give it such jurisdiction. If the FDA gains jurisdiction over tobacco, but has little power to regulate advertising, it would not be able to protect public health from the tobacco companies. Advertising of tobacco should be illegal in the United States.
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? Corporations use advertising to drive a wedge between parents and children, and seduce children to nag for junk food and other items that many parents oppose.
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? When corporations enjoy First Amendment protections it essentially nullifies the speech rights of individuals, since individuals cannot afford the massive advertising campaigns that corporations wage, and so cannot talk back.
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? Restrictions on the advertising of tobacco, alcohol, gambling and pharmaceuticals are essential for protecting public health. Of all the problems facing our country, insufficient advertising of cigarettes, liquor, etc. is not one of them.
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? Corporations are far too powerful already. The FDA should seek the right balance between individuals and corporations in the arena of public health, and not tip it further towards corporations and their lobbyists in our nation?s capital.
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? Direct-to-consumer drug advertising exists primarily to promote the sale of drugs, not to educate.
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? For the FDA, public health should be a higher priority than protecting corporations or their right to advertise.
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? Due largely to the assault of marketing to children, there have been marked increases in marketing-related diseases, such as childhood obesity and type 2 diabetes.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Children are especially vulnerable to advertising, because corporations use sophisticated psychological techniques to trick them, and because children lack the maturity to deal with these techniques.

EC -324