Podcast: Non-binding Guidance: Former FDA Commissioner Scott Gottlieb’s Unfinished Business
Podcast - Developments in FDA & DOJ Regulation and Enforcement of Manufacturer Communications
In this post, I will be focusing on the intersection of off-label communications with government enforcement of health care fraud through the False Claims Act. Over the past eight years, the U.S. Department of Justice (“DOJ”)...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
For more than a decade, the Department of Justice (DOJ) has zealously pursued enforcement actions against the health care industry. Given the continued growth in government spending on health care and the billions of dollars...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