Like many biopharma companies, Regeneron has been ensnared in a U.S. probe over its charity contributions for several years. But while many drugmakers have already settled allegations their contributions were kickbacks, the New York company is pledging to fight a new lawsuit from federal authorities.
In a lawsuit Wednesday, the U.S. Attorney’s Office for the District of Massachusetts alleged Regeneron gave tens of millions of dollars to a patient foundation that acted as a "conduit" to boost sales. The funds were used to pay Medicare patients' copays on blockbuster eye medicine Eylea, the DOJ says, but not for rival medications.
“Regeneron allegedly paid these substantial sums only after confirming that the foundation needed the money to cover co-pays only for Eylea, and not for competing drugs, and that the company’s payments would generate a handsome return on investment, or ‘ROI,’ in the form of Medicare payments for Eylea,” U.S. attorney Andrew Lelling said in a statement. “Furthermore, senior company executives allegedly took extensive measures to cover up the scheme.”
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Regeneron took a tough stance against the lawsuit—and picked a bone with its timing. It’s “unfortunate that the government chose to bring these baseless allegations related to our 2013 and early 2014 patient assistance donations at a time when Regeneron employees have been coming to work in the epicenter of the COVID-19 pandemic with the goal of providing an effective treatment," Regeneron’s general counsel Joseph LaRosa said in a statement.
The company’s donations to "independent charity foundations help elderly patients access medicines that are prescribed by their physicians," he added.
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Regeneron’s decision to defend itself against the allegations comes after many of its peers have decided to settle allegations that charity contributions were kickbacks. Pfizer, Sanofi, Astellas, Amgen, Alexion and United Therapeutics are among the many companies that have settled their allegations amid an industrywide probe that has lasted several years.