On April 29, 2025, the U.S. Attorney’s Office for the Southern District of New York (SDNY) announced a $202 million civil False Claims Act (FCA) settlement with Gilead based on allegations that the company’s speaker program violated the Anti-Kickback Statute.1 While the headline is attention-grabbing, the resolution pertains to historical conduct predating the November 2020 Special Fraud Alert from the U.S. Department of Health and Human Services’ Office of Inspector General (HHS-OIG) on speaker programs and bears strong similarities to a number of other speaker program-based settlements over the past five years.
This is the second settlement involving similar allegations since the Trump administration took office. As such, the settlement is perhaps more notable insofar as it serves to remind life sciences companies of the types of speaker program compliance analyses manufacturers may wish to consider performing, and more generally of the importance of maintaining rigorous controls around speaker program activities.
Gilead agreed to pay $202 million to resolve a nearly decade-old qui tam case initially filed by a physician relator who treated patients diagnosed with HIV/AIDS. As is typical for civil FCA settlements with the SDNY, Gilead was required to admit and accept responsibility for certain conduct. According to the settlement papers, between 2011 and 2017 the company paid 548 healthcare providers more than $23.7 million in the form of honoraria,...
KUALA TERENGGANU, Aug 26 (Bernama) -- The Malaysian Anti-Corruption Commission (MACC) Terengganu branch today remanded a real estate agent from a company in the state on suspicion of submitting cl...