Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -30

Accepted - Volume 1

Comment Record
Commentor Mr. Scott Maley Date/Time 2002-05-28 22:32:19
Organization Mr. Scott Maley
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? Are you asking for comments from lawyers, or the public? Argue all you like, the FDA is no arbiter of the truth.
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? Consumers are constantly bombarded with less-than-completely truthful advertisements. Consumers would welcome unbiased sources of information. It is our responsibility to discern whether information is truthful, not doctors, industry, or the FDA.
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? What FDA may attempt to distinguish is likely to have little bearing on whether labeling is truthful. The Law (whether cited by U.S.C., or Judge Dredd) can only distinguish claims when the issues can be easily understood. One may consider the validity of law or regulation to be inversely proportional to the number of words used.
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? The size of the typeface is less important than whether the (dis)claims can be reasonably represented on something as small as a label.
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? Only God can prevent harm, and the evidence is unclear on even that point. How could any warning be effective for all of the hundreds of millions of consumers in the US? Some Americans believe what authority figures tell them. Some appear to be guided by inner demons (or whimsy). A few weigh the evidence and decide for themselves.
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? Social Science, AND relevant. You are really grasping at straws...
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? If it were found that putting crossing guards at more than just school crossings were effective in reducing accidents, should FDA have the authority to regulate that off-label use?
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? Irrelevant... See number 9.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? The FDA has no power to regulate speech, in ANY fashion that skirts, subverts, or otherwise contravenes the First Amendment. Stop trying to define is!

EC -30