This is Part 3 in my series exploring the history of FDA’s regulation of off-label communications, which has become newly relevant in light of the recent events highlighted in Part 1. In this installment, I continue...more
The Amarin settlement represents another important development in the FDA’s enforcement of off-label promotion. On March 8, 2016, US District Court Judge Paul A. Engelmayer entered a Stipulation & Order of Settlement in...more
Irish drug company Amarin Pharma, Inc. (Amarin) and the U.S. Food and Drug Administration (FDA) agreed, on March 8, 2016, to settle claims that FDA regulations barring Amarin from making “truthful” and “non-misleading”...more
In a surprising turn of events, Pacira Pharmaceuticals, Inc. and the Food and Drug Administration (FDA) announced that they have settled their dispute regarding the off-label promotion of Exparel, one of Pacira’s anesthetic...more
Three years ago, in United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that the Federal Food, Drug and Cosmetic Act (FDCA) neither prohibits nor criminalizes truthful, nonmisleading speech that...more
Major Medicaid Drug Payment Rule Under OMB Review: Last week a highly anticipated rule that could set the standards for the Medicaid Drug Rebate program arrived at the White House for final review. The Medicaid Outpatient...more
Amarin is an important US district court opinion affirming the importance of the Second Circuit’s Caronia decision and finding that pharmaceutical and medical device companies have a constitutionally protected right to...more