Dive Brief:
- Boston-based Alexion Pharmaceuticals Inc. has agreed to pay more than $21 million to resolve charges it violated the books and records and internal accounting controls provisions of the Foreign Corrupt Practices Act (FCPA), the Securities and Exchange Commission (SEC) announced.
- "Alexion's internal accounting controls failed to detect and prevent payments to foreign government officials by its subsidiaries," said Melissa Hodgman, SEC associate director of enforcement.
- According to the SEC's order, two Alexion subsidiaries made payments to foreign government officials to secure favorable treatment for Alexion’s primary drug, Soliris.
Dive Insight:
From 2010 to 2015, the SEC says, Alexion Turkey paid Turkish government officials to improperly influence them to approve patient prescriptions and provide other favorable regulatory treatment for Soliris.
In addition, from 2011 to 2015, Alexion Russia made improper payments to Russian government health care officials to favorably influence the regulatory treatment of and the budget allocated to Soliris as well as to increase the number of approved Soliris prescriptions.
Alexion Russia and Alexion Turkey maintained false books and records of these improper payments, which Alexion’s internal accounting controls couldn't detect or prevent. Further, the order found Alexion's subsidiaries in Brazil and Colombia failed to maintain accurate books and records, including by creating or directing third parties to create inaccurate financial records concerning payments to patient advocacy organizations.
"Companies in frequent contact with foreign officials need to ensure that their internal controls appropriately address such risks," Hodgman said.
Without admitting or denying the SEC’s findings, Alexion agreed to cease and desist from committing violations of the books and records and internal accounting controls provisions of the FCPA, and pay $14,210,194 in disgorgement, $3,766,337 in prejudgment interest, and a $3.5 million penalty.
