Gilead agrees $97 million settlement with DoJ over kickbacks

US biotech major Gilead Sciences (Nasdaq: GILD) has agreed to pay $97 million to resolve claims that it violated the False Claims Act by illegally using a foundation as a conduit to pay the co-pays of thousands of Medicare patients taking Gilead’s pulmonary arterial hypertension drug, Letairis (ambrisentan), the US Justice Department announced yesterday.

In a statement, Gilead said it addressed concerns raised by the government, and does not believe it violated the law. It also said there was no allegation that patients who received medication did not need it.

“Like its competitors, Actelion and United Therapeutics, Gilead used data from CVC that it knew it should not have, and effectively set up a proprietary fund within CVC to cover the co-pays of just its own drug,” said US Attorney Andrew Lelling for the District of Massachusetts. “Such conduct not only violates the anti-kickback statute, it also undermines the Medicare program’s co-pay structure, which Congress created as a safeguard against inflated drug prices. During the period covered by today’s settlement, Gilead raised the price of Letairis by over seven times the rate of overall inflation in the United States,” he added.