CME for off-label device uses is not shielded by First Amendment -- Public Citizen..
This article was originally published in The Gray Sheet
Executive Summary
INDUSTRY-SPONSORED TRAINING IN OFF-LABEL DEVICE, DRUG USES constitutes "misleading" promotional activity and is "therefore not entitled to first amendment protection," Public Citizen argues in Feb. 16 comments to FDA. The comments respond to a Washington Legal Foundation petition challenging FDA's authority to regulate discussion of unapproved device or drug uses at industry-sponsored continuing medical education forums.