The U.S. Attorney’s Office for the District of Massachusetts isn’t the only one investigating Alexion over its support of organizations that help Medicare patients.
The U.S. Department of Health and Human Services’ Office of Inspector General—which probes potential waste, fraud and abuse in Medicare, Medicaid and other HHS programs—is investigating the situation, too. As the OIG told Bloomberg Thursday, there is an “open and ongoing investigation” into the Connecticut biotech, which said in a statement that it is “aware” that the OIG is “working on this inquiry with the U.S. Attorneys’ Office and the Department of Justice.”
“At this time, Alexion has not received a request for records from the HHS Office of Inspector General pertaining to any other matter,” a spokeswoman said via email.
The news follows Alexion’s January disclosure that it last December received a subpoena from the U.S. Attorneys’ Office for the District of Massachusetts, asking, in part, for documents related to company’s support for organizations that provide financial help to Medicare patients taking Alexion’s drugs.
“Other companies have disclosed similar inquiries,” the drugmaker was quick to point out at the time, noting in a regulatory filing that “we are cooperating with this inquiry.”
It’s not the first investigation into Alexion’s sales practices as of late. Also in January, the rare-disease specialist wrapped up an internal investigation which determined that in order to hit financial targets, Alexion’s top brass pressured employees to get customers to place orders for lead med Soliris earlier than they would have otherwise. Over the course of that probe, then-CEO David Hallal and CFO Vikas Sinha made their exits.
Alexion’s practices abroad are under the lens, too. Back in May, Brazilian authorities raided the company’s Sao Paulo offices as part of an investigation into whether the company, helped by a local patient association, subsidized lawsuits for patients to gain access to Soliris through Brazil’s national health system. Alexion has also said the U.S. Securities and Exchange Commission and the Department of Justice are probing it for issues related to the Foreign Corrupt Practices Act.
Meanwhile, it’ll be up to new CEO Ludwig Hantson, former helmsman of Baxalta, and his team of fresh hires to right the ship. “Hantson has made it clear that compliance is a key initiative of his new strategy for Alexion,” Barclays analyst Geoff Meacham wrote in a note to clients last month, and Hantson underscored that point by recently bringing on Pfizer vet Indrani Franchini as chief compliance officer and leader of Alexion’s newly formed Global Corporate Compliance Committee.
“We ... see this commitment to compliance as positive as it can help prevent legal and ethical issues that caused problems for Alexion, previously,” Meacham wrote.