July 2, 2020

Alexion Pharmaceuticals settles FCPA investigation

On July 2, 2020, Alexion Pharmaceuticals, Inc., a Massachusetts-based pharmaceutical company, agreed to pay $21.5 million to the US Securities and Exchange Commission to resolve charges that it had violated the books and records and internal controls provisions of the US Foreign Corrupt Practices Act.  
According to the SEC’s order, from 2010 to 2015 Alexion’s Turkish subsidiary paid Turkish government officials, both directly and through a third-party consultant, to improperly influence them to “approve patient prescriptions and provide other favorable regulatory treatment” for Alexion’s drug Soliris.  Similarly, from 2011 to 2015, Alexion’s Russian subsidiary paid Russian government officials to influence Soliris’ regulatory treatment and to “increase the number of approved Soliris prescriptions.”   Finally, from 2013 to 2015, employees at Alexion’s Brazilian and Colombian subsidiaries created, and directed third parties to create, inaccurate financial records concerning payments to third parties, including patient advocacy organizations.  As a result of this conduct, the SEC’s order finds that Alexion’s Turkish, Russian, Brazilian, and Colombian subsidiaries failed to accurately record these payments in their books and records, and that in both Turkey and Russia Alexion’s internal controls were insufficient to “provide reasonable assurances” that no improper payments would be made.
Without admitting or denying the SEC’s findings, Alexion agreed to cease and desist from committing violations of the FCPA’s books and records and internal controls provisions, and to pay a $3.5 million penalty, as well as $14. 2 million in disgorgement and $3.8 million in prejudgment interest.  The SEC noted in its order that Alexion had cooperated with the SEC and had engaged in numerous remedial efforts, which the SEC took into account when resolving this matter.  
In May 2020, Alexion previously announced that the US Department of Justice had closed its inquiry into the same matters.

SEC press release | Alexion press release | SEC order