Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -110

Accepted - Volume 2

Comment Record
Commentor Mr. Jeremy Souder Date/Time 2002-06-04 16:43:09
Organization Univ of Penn School of Medicine
Category Academic

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? could FDA sustain a position that certain promotional speech about drugs is inherently misleading, unless it complies with FDA requirements? I would hope so.
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? positive and negative effects, if any, of industry's promotion of prescription drugs, biologics, and/or devices: positive-keep docs abreast of new advances. BUT: NEGATIVES: patients push docs for meds that they may not really need, that may be appropriate but far more expensive compared to equally effective generics or alternate agents. Does the current regulatory approach and its implementation by industry lead to over-prescription of drugs? Yes. Do they cause patient visits that lead to treatment for under-diagnosed diseases? Perhaps, but the much greater effect is that they cause people who suspect (almost always incorrectly) that they have disorders that they do not.
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? Should disclaimers be required to be in the same (or smaller or larger) size of type and given equal prominence with claims? Yes.




EC -110