The US Attorney’s Office announced that the government has filed a civil False Claims Act complaint against drug manufacturer Regeneron Pharmaceuticals, Inc. (Regeneron), of Tarrytown, NY. The complaint alleges that Regeneron paid tens of millions of dollars in kickbacks for its macular degeneration drug Eylea, using a foundation as a conduit to cover co-pays for Eylea. The complaint alleges that, in 2012, soon after the launch of Eylea, Regeneron considered how much to pay a foundation that covered Medicare co-pays for patients taking macular degeneration drugs. Regeneron’s senior management was willing to pay the foundation only enough to cover Medicare co-pays for Eylea patients. The government alleges that Regeneron’s conduct violated the anti-kickback statute which prohibits “indirect” kickbacks to subsidize the price of a Medicare drug.
The government further alleges that Regeneron’s senior management knew the conduct was illegal. In 2013, company auditors twice inquired about the information Regeneron was getting from the foundation about Eylea. Both times, Regeneron management, including the company’s commercial chief, lied, and asserted that the company was not getting Eylea-specific data from the foundation. In fact, as the executives knew, the company was getting frequent Eylea-specific reports from the foundation and then using that data to correlate the company’s payments to the foundation with the foundation’s spending on co-pays for Eylea. As a result, the government alleges, the physicians who prescribed and purchased Eylea rarely, if ever, had to consider the drug’s substantial cost, because they knew that the foundation would cover their patients’ Medicare co-pays.
