FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Amgen, Astellas Pay $125 Million to Settle Federal Kickback Allegations 

May 3, 2019

Amgen and Astellas Pharma have agreed to pay nearly $125 million to settle federal allegations that they exploited charities to protect the prices of their favored drugs.

The companies have each denied wrongdoing but said they agreed to the settlements to avoid further distractions. Under law, they could have been facing treble damages and individual fines for each offense had they lost at trial. Whistleblowers alleged in separate complaints that the companies use of charitable donations broke anti-kickback laws. 

Since December, the Department of Justice has announced nearly $607 million settlements with drugmakers who the feds say used charitable foundations that offered copay help to needy customers as a way to bilk Medicare by locking out cheaper competitors.

Under the settlements, announced Thursday, Astellas will pay $100 million to settle claims that it created two charitable funds that only supported copays for its prostate cancer treatment Xtandi (enzalutamide). Astellas will also enter into a corporate integrity agreement with the HHS inspector general that will last through 2024.

In a statement, Astellas denied any wrongdoing. “These donations were conducted with the understanding that our actions were lawful and appropriate,” the company said.

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