Astellas Pharma agreed to pay $7.3 million to settle civil allegations by one of its sales representatives that the company wrongly marketed the antifungal drug Mycamine (micafungin sodium) for injection to children years before being approved for purpose, while submitting fraudulent claims to government healthcare programs.
The allegations were contained in a qui tam court complaint filed by the sales rep in 2010, alleging that Astellas increased the sales of Mycamine by marketing it for off-label use in children, as well as by making illegal claims for government reimbursement. The qui tam provisions of the False Claims Act allow individuals to join in a lawsuit on behalf of the government, then share in the proceeds.
At the time, Mycamine was approved only for adults and not for use in children by the FDA for intravenous use to treat the yeast fungus candida and thrush infections in the throat, stomach, in abscesses and other areas of the body. FDA extended its approval of Mycamine to include children four months and older in June 2013.
Mycamine is indicated for treatment of patients with candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses, as well as patients with esophageal candidiasis, and protection from Candida infections in patients undergoing hematopoietic stem cell transplantation.
The lawsuit was joined by more than two dozen states that hoped to recover funds paid to Astellas by Medicare, Medicaid, Tricare and other government payer programs.
The complaint and other documents in the case were unsealed Wednesday by the U.S. Attorney’s Office for the Eastern District of Pennsylvania. That day, news of the settlement was disclosed by the law firm representing the salesman, Sheller P.C.
Astellas confirmed the settlement yesterday in its own statement, which noted that the company had consistently denied the allegations. Astellas did not admit any liability in the settlement, which also stated it was not a concession by the U.S. that its claims were not well-founded.
"Astellas cooperated fully with the U.S. Government's review of this matter, and we are pleased to have reached a resolution," Astellas Pharma U.S. CEO Masao Yoshida said in his company’s statement. “In keeping with our corporate commitment to conduct business with a high sense of ethics, our policy has always been to promote our products in accordance with FDA regulations.”
Sheller’s team of lawyers representing the whistleblower was led by the firm’s founding partner, Stephen Sheller, and included a former Assistant U.S. Attorney, Joseph Trautwein
The case is officially known as United States ex rel. F.S., et al. v. Astellas Pharma US, Inc., et al., No.10-999.