Gilead inks $97M charity kickbacks settlement with feds, but argues it did no wrong

Gilead
Gilead inked a $97 million settlement over kickbacks allegations from the U.S. government. (Gilead China)

Amid an industrywide kickbacks investigation into pharma's charity contributions, Gilead Sciences has become the latest drugmaker to strike a deal. Though the company says it doesn't believe it violated any laws, it agreed to pay $97 million to resolve kickbacks allegations.

Gilead inked the settlement with the Department of Justice (DOJ) to resolve claims it used a patient foundation as a “conduit” to cover Medicare patients’ copays for Letairis, a pulmonary arterial hypertension drug that’s now off patent.

Gilead is the latest drugmaker to strike a deal in the yearslong probe, following settlements of various sizes for Sanofi, Pfizer, Astellas, Amgen, Alexion and United Therapeutics, among others. 

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The feds say Gilead’s payments to the foundation between 2007 and 2010 were used to cover patient copays for Letairis. Gilead had routine access to the foundation’s data and used that information to decide how much to give, the feds allege. Gilead further knew the price it had set for Letairis could pose a barrier to patients filling prescriptions, the DOJ says.

RELATED: Teva funneled kickbacks through copay assistance charities for MS med Copaxone: DOJ

Plus, Gilead specifically referred Medicare patients to the foundation for assistance, the DOJ says. Under federal law, pharma companies cannot, either “directly or indirectly,” make payments to induce Medicare patients to purchase their medicines. That includes payments for copays. 

The agency won't "permit pharmaceutical manufacturers to set unaffordable drug prices while circumventing important cost-control mechanisms within the Medicare program,” acting Assistant Attorney General Jeffrey Bossert said in a statement. 

Gilead sees things differently. The company “made its donations following guidance issued by the U.S. Department of Health and Human Services that permits companies to make donations to assist patients with their required copays for medications,” general counsel Brett Pletcher said in a statement.  

“Gilead does not believe it violated the law and had no intention of doing so,” he added. Gilead didn’t admit guilt with the settlement, and Pletcher pointed out that there “was never any allegation in this case that patients who received aid and medication did not need it or did not benefit from it.” 

RELATED: Regeneron vows to fight DOJ lawsuit alleging charity donations were Eylea kickbacks

As Gilead sees it, the company’s donations “facilitated access to treatments for people living with this life-threatening condition—including patients who were prescribed medications made by competitors,” Pletcher said. 

While the federal government has been successful in inking deals with numerous biopharma companies so far, it's also sued Teva and Regeneron in recent months. Those companies have vowed to fight the allegations.

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