Further, the order finds that 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. The investigation started in 2015, according to the company’s earlier SEC filings. Keep up to date with significant developments in the corporate investigations world. It says the company’s co-operation included providing regular briefings on the facts developed in the internal investigation and forensic accounting review Alexion undertook, and identifying and providing translations of key documents. Alexion Pharmaceuticals Inc. is an American pharmaceutical company best ... on June 12, Alexion received a court gag order against Pharma, preventing it from communicating its investigation. Alexion’s disclosure states: “In May 2015, we received a subpoena in connection with an investigation by the Enforcement Division of the Securities and Exchange Commission (SEC) requesting information related to our grant-making activities and compliance with the Foreign Corrupt Practices Act (FCPA) in various countries. From 2010 to 2015, Alexion’s subsidiary in Turkey paid foreign officials for favorable regulatory treatment and to approve prescriptions for patients. During the time period of 2010 to 2015, Alexion paid the consultant over $1.3 million, consisting of consulting fees and purported expense reimbursements. Alexion disguised some of the payments to the consultant by asking a third-party vendor to pay the consultant and provide false invoices for reimbursement to Alexion. 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. Without admitting or denying the SEC’s findings, Alexion agreed to pay a $3.5 million penalty, plus $14.2 million in disgorgement and about $3.8 million in prejudgment interest. At the same time, Pharma opened a court case against Alexion Pharma Belgium. Its first drug, Soliris was approved to treat two ultra-rare diseases, paroxysmal nocturnal hemoglobinuria (“PNH”), which causes red blood cells to split apart, and atypical hemolytic uremic syndrome (“aHUS”), which reduces red blood cell count and causes kidney dysfunction. A federal investigation that Alexion Pharmaceuticals settled for $21.5 million last week found the drugmaker paid bribes to Turkish and Russian government officials to gain favorable regulatory treatment for its blockbuster drug Soliris, according to details released by the SEC. Global Investigations Review - Alexion settles with SEC … Physician A was paid over $100,000 from 2012 to 2015. Pharmaceutical company Alexion is in “preliminary discussions” with the SEC to resolve a foreign bribery investigation. Today, it was announced that Alexion finalized its settlement with the U.S. Securities and Exchange Commission (SEC) to resolve the previously disclosed investigation related to the company’s compliance in certain countries with the Foreign Corrupt Practices Act (FCPA) and other applicable laws. Alexion Pharmaceuticals Strikes Tentative $25 Million Bribery Settlement The biopharmaceutical company has reached a settlement in principle with the SEC, it said. An SEC investigation determined that Vijay S. Rajan of Bolingbrook, Illinois learned about the impending transaction in April 2015, through his work as an information technology executive at Alexion. Alexion nears $25M settlement with SEC in FCPA probe. Alexion’s violations revolved around its primary drug, Soliris. 5 Flickr 6LinkedIn 7 Pinterest 8 Email Updates. To see what you're missing. By 2015 regulators were onto Alexion’s schemes. “Companies in frequent contact with foreign officials need to ensure that their internal controls appropriately address such risks.”. To assist with the patient approval process, Alexion hired a consultant, primarily because of the consultant’s connections to top Turkey Ministry of Health officials. From 2011 to 2015, Alexion paid Physicians B and C for honoraria, research and education expenses, and in grants to the institution that employed Physician C.  Physicians B and C were geneticists and chief advisors to the Ministry of Health. Independent Investment Research Focused on Public Company Interactions with the SEC. In its latest action, the SEC settled with Alexion Pharmaceuticals for $21 million for foreign bribery and books and records violations. Alexion is cooperating with these investigations. Terms of the agreement took into account remedial acts undertaken by Alexion and its co-operation with SEC officials, according to the order. According to the SEC… As previously disclosed, Alexion first received a subpoena in May 2015 concerning an investigation by the SEC’s Enforcement Division “requesting information related to our grant-making activities and compliance with the FCPA in various countries.” 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. Alexion Pharmaceuticals Thursday morning said it would pay $21.5 million to settle a federal probe into allegations that it violated anti-bribery laws. Yesterday, the SEC announced that Alexion Pharmaceuticals (a company that has been under scrutiny since mid-2015) agreed to approximately $21.5 million to resolve an enforcement action based on the actions of foreign subsidiaries involving the company’s primary drug Soliris. In May this year, Alexion said it received a declination from the DOJ for the FCPA investigation. The Securities and Exchange Commission today announced that Boston-based pharmaceutical company Alexion Pharmaceuticals Inc. has agreed to pay more than $21 million to resolve charges that it violated the books and records and internal accounting controls provisions of the … The information found on our website is not part of this or any other report we file with, or furnish to, the SEC. Alexion paid HCPs in Russia who were employed at government institutions for services, including research, consu;ting on specific topics and hosting educational events. Note: The content provided by Michael Volkov on the Corruption, Crime & Compliance blog is not intended to be legal advice and viewing the materials does not create an attorney-client relationship. The pharmaceutical company has agreed to resolve a foreign bribery investigation by the SEC for under $25 million. Pharmaceutical company Alexion is in “preliminary discussions” with the SEC to resolve a foreign bribery investigation. Alexion is a global pharmaceutical company. The HCPs were responsible for approving or denying patient prescriptions for Soliris and were key influencers on regulatory matters such as treatment guidelines and reimbursement. Washington, D.C. 20037, Alexion FCPA Violations: Lessons Learned (Part II of II), Webinar: Catching Up with DOJ Compliance Program Guidance, Dancing Around the Edges: A Journey in the FCPA Guidance, The FCPA Guidance and Voluntary Disclosures, A Call to Arms: Conduct a Risk Assessment, Board and Fraud – a Jonathan T. Marks Blog, Compliance Workshop! The company said the DOJ in October asked for the voluntary production of documents related to the investigation. Tags: Alexion PharmaceuticalsAlexion SEC Settlementbooks and recordsFCPA Violations, Episode 185 – Anti-Boycott Compliance: Interview of Alex Cotoia from the Volkov Law Group, Webinar: Leverage Due Diligence to Improve Enterprise-Wide Risk Management. The order similarly finds that 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 Pharmaceuticals, Inc. - SEC Investigation Update. Alexion made honoraria and research payments to Physician A in significant part to influence the regional budget in favor of Soliris. Soliris is approved for use in more than 50 countries. The SEC order doesn’t say how regulators came to be aware of the misconduct, such as whether the company disclosed its misdeeds voluntarily. Alexion Russia and Alexion Turkey maintained false books and records of these improper payments, which Alexion’s internal accounting controls were not sufficient to detect or prevent. Alexion unveiled the proposed $25 million settlement in its recent quarterly securities filing. 1 Twitter 2 Facebook 3RSS 4YouTube For example, in 2013 and 2014, an Alexion Brazil manager caused a PAO to pay for the manager’s personal expenses for alcohol and personal travel, and to submit a fictitious invoice, which was reimbursed by Alexion Brazil. Notwithstanding the pandemic and remote working arrangements, the Securities and Exchange Commission is continuing to bring FCPA enforcement actions. The SEC’s investigation was conducted by Christina McGill and Brittany Hamelers. Alexion subsidiaries in those two countries paid officials to influence patient prescriptions and regulatory approvals of Soliris, a drug used to treat rare blood diseases, an SEC investigation found. Further, Alexion Brazil and Alexion Colombia failed to maintain adequate books and records of certain of its financial transactions involving payments to third parties. Preliminary discussions have begun with the SEC to resolve the investigation. Notwithstanding the pandemic and remote working arrangements, the The order finds that, from 2010 to 2015, Alexion Turkey paid Turkish government officials to improperly influence them to approve patient prescriptions and provide other favorable regulatory treatment for Soliris. The Boston-based company settled the claims without admitting or denying the regulator’s findings. Alexion paid both physicians in significant part to influence them in favor of Soliris. Physician A provided Alexion with a copy of draft diagnostic standards and solicited Alexion’s comments on the standards. But from then forward, Alexion did cooperate with the investigation and boosted its compliance efforts substantially. In determining the penalties, the SEC considered Alexion’s cooperation, which included regular briefings to SEC staff regarding the facts developed in its internal investigation in multiple countries and the forensic accounting review that Alexion undertook as well as identifying and providing translations of key documents. For example, from 2012 to 2014, Alexion paid over $15,000 to an HCP who was decision maker for reimbursement criteria for aHUS and for patient prescriptions for Soliris. Fourth Floor East, Washington D.C., July 2, 2020 — The Securities and Exchange Commission today announced that Boston-based pharmaceutical company Alexion Pharmaceuticals Inc. has agreed to pay more than $21 million to resolve charges that it violated the books and records and internal accounting controls provisions of the Foreign Corrupt Practices Act (FCPA). The investigation was supervised by Timothy England and Melissa Hodgman. Legal news service Law360 reported the complaints stem from Alexion operations in Japan, Brazil, Turkey and Russia. The Probe. Alexion Pharmaceuticals said in a regulatory filing that it is nearing a $25 million settlement with the Securities and Exchange Commission concerning an investigation into the company’s compliance with the Foreign Corrupt Practices Act spanning various countries. Alexion representatives said in a Friday statement to the News that they are fully cooperating with SEC’s and DOJ’s orders. The investigations have focused on operations in various countries, including Brazil, Colombia, Japan, Russia and Turkey, and Alexion’s compliance with the FCPA and other applicable laws. An internal document stated that Alexion hoped to “receive support to include [ultra-rare diseases treated by Alexion drugs] in all possible lists.”  After making the payments to Physician C and his organization, an Alexion employee stated that Physician C “cooperated” with Alexion Russia on the “programs within [Physician C’s] influence on regions in terms of standards and funding, through [Physician C’s] specialized committee.”. Become a Paid Subscriber! Stay Informed. Connecticut-based Alexion received a subpoena from the SEC in May. The consultant used a portion of these funds to provide government officials with cash, meals and gifts to secure favorable treatment for Soliris. The Securities and Exchange Commission today announced that Boston-based pharmaceutical company Alexion Pharmaceuticals Inc. has agreed to pay more than $21 million to resolve charges that it violated the books and records and internal accounting controls provisions of the Foreign Corrupt Practices Act (FCPA). 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.