Podcast: Non-binding Guidance: Former FDA Commissioner Scott Gottlieb’s Unfinished Business
A judge in the District of Massachusetts recently questioned whether Congress intended to criminalize off-label promotion through misbranding and adulteration statutes. In an order denying a Rule 29 motion brought by two...more
The US Food & Drug Administration (FDA) serves as the gatekeeper between pharmaceutical companies and the public they serve, including governing how medications are promoted and advertised. Pharmaceutical companies want to go...more
Picking up from my last installment of this series exploring the regulatory history of off-label communication, this post highlights some recent trends in FDA enforcement and guidance related to off-label promotion. Not...more
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
On the eve of a change in administration, the U.S. Food and Drug Administration (FDA or the Agency) released a flurry of documents regarding off-label communications and FDA’s ability to regulate such communications within...more
The U.S. Food and Drug Administration (FDA) received another blow to its ability to regulate pharmaceutical product marketing that was dealt via a court order stating it is not in the agency’s purview to control promotional...more
The Free Speech Clause notched another victory in the latest and, perhaps, final chapter of the lawsuit between the FDA and Amarin Pharma, Inc. concerning off-label marketing of an FDA-approved drug. On March 8, 2016, the FDA...more
FDA agrees to allow truthful and non-misleading off-label promotion. On March 8, the US District Court for the Southern District of New York approved settlement terms in connection with Amarin Pharma, Inc., et al. v....more
To quote the late Yogi Berra, it must feel like déjà vu all over again for the Food and Drug Administration (FDA) (or, if you prefer, Crosby, Stills, Nash & Young’s song, “Déjà Vu” (“We have all been here before”)). Fresh off...more
Following the Second Circuit’s marquee First Amendment ruling in the Caronia case, two recent developments demonstrate a shift in the battleground for First Amendment challenges to the prohibition on off-label promotion under...more
On March 4, 2013, a panel of the United States Court of Appeals for the Ninth Circuit issued its opinion in United States v. Harkonen,1 a case in which the CEO of a pharmaceutical company was prosecuted for transmitting...more
After two years of deliberation, the U.S. Second Circuit Court of Appeals has finally issued its decision in United States v. Caronia, holding that the government cannot prosecute pharmaceutical manufacturers or their...more