April 25, 2019

Astellas Pharma US Inc. has agreed to pay $100 million and enter into a corporate integrity agreement to resolve allegations that its use of a purportedly independent foundation to pay copayments on its drug Xtandi for Medicare beneficiaries violated the False Claims Act.  Astellas was alleged to have provided funds to cover copayments for androgen receptor inhibitors (ARIs), although its own drug Xtandi was the only ARI available.  Astellas promoted the existence of the funds as an advantage for Xtandi over competing drugs in an effort to persuade medical providers to prescribe Xtandi. According to the government’s allegations, payments to the foundations were not bona fide donations, but instead unlawful kickbacks.   DOJ; USAO Mass

Tagged in: Anti-Kickback and Stark, Drug and DME Pricing, FCA Federal, Pharma Fraud,