Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -349

Accepted - Volume 6

Comment Record
Commentor Dr. Elizabeth O'Connor Date/Time 2002-09-06 12:55:49
Organization Kaiser Permanente Center for Health Research
Category Health Professional

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? Advertising prescription medication is virtually always misleading in some way, the those who are most vulnerable to being mislead (young, compromised cognitive, emotional, or health status) are in great need of FDA protection. I absolutely oppose equating individual's first amendment rights with those of corporations. Individuals do not have the resources to oppose misleading advertising of corporations. FDA SHOULD CLOSELY MONITOR AND LIMIT ADVERTISING OF DRUGS. The FDA has a public health mission, not a business-promotion mission.




EC -349