The feds, which Friday extracted a guilty plea from Aegerion for paying kickbacks to a charity set up to help patients buy drugs, have expanded their probe into the patient assistance group itself.
Patient Services, the group named in the wide-ranging case against Aegerion, today acknowledged that it not only cooperated in the case against Aegerion but has been contacted by the U.S. Attorney’s Office in Massachusetts in regard to its overall probe, Reuters reports.
The group, which helps patients cover out-of-pocket costs on expensive drugs, denied doing anything wrong and said it was cooperating with authorities. “PSI operates under guidelines set by the U.S. Health and Human Services Department Office of the Inspector General and does not ‘funnel funds’ for manufacturers,” it told the news service.
Aegerion, now a unit of Novelion, agreed to pay $40 million to settle the DOJ civil case, which included a laundry list of bad behavior related to Juxtapid. Aegerion acknowledged it pushed the cholesterol drug outside of the drug's FDA approval, violated risk-management regulations as well as broke anti-kickback laws with charity donations.
The investigation into whether drugmakers have used donations to groups like Patient Services in exchange for the charities steering patients to donors drugs has roped in a number of top drugmakers. Johnson & Johnson, Pfizer, Biogen, Gilead and Celgene have all disclosed being contacted. Celgene also faces a whistleblower suit claiming the company worked to “game the system” with contributions to steer charities toward its drugs. The companies have denied pressuring the charities for preferential treatment.
While Aegerion is the first to publicly acknowledge it did something wrong, there are indications that the DOJ has increased the heat on other companies. Last month, United Therapeutics disclosed in a filing that it had set aside $210 million for a potential settlement with the government over its contributions to copay assistance charities.