Aegerion Pharmaceuticals Inc. will plead guilty to two misdemeanors and pay $40.1 million to resolve investigations into its marketing and sales of the expensive cholesterol drug lomitapide (Juxtapid), according to a Reuters report. The settlements will resolve long-running investigations into Aegerion, a subsidiary of Canada’s Novelion Therapeutics Inc., by the U.S. Justice Department, the U.S. Securities and Exchange Commission, and the U.S. FDA.
Under the agreements, Aegerion will plead guilty to two misdemeanor drug misbranding violations of the Food, Drug, and Cosmetic Act, pay $36 million to resolve cases by the Justice Department, and pay $4.1 million to settle the SEC’s lawsuit. It also entered into a deferred prosecution agreement to resolve a charge that it conspired to violate the Health Insurance Portability and Accountability Act.
The settlements finalized agreements Aegerion disclosed in May 2016. The Cambridge, Massachusetts-based company in November merged with QLT Inc. and became a subsidiary of the newly named Novelion, Reuters reported. “We are eager to get the problems that occurred with Aegerion under prior leadership behind us, and we believe these agreements are in the best interest of shareholders,” Aegerion said in a statement.
Prosecutors said that after the FDA in 2012 approved Juxtapid for treating a rare genetic condition that causes high cholesterol, Aegerion promoted it for patients who had not been diagnosed with the condition, according to the Reuters report.
Juxtapid, which cost $250,000 to $300,000 annually per patient, featured a boxed warning on its label that it could cause serious liver and stomach problems, prosecutors said. Documents filed in federal court charged that Aegerion failed to comply with the requirements of the Juxtapid Risk Evaluation and Mitigation Strategy (REMS) program and that the drug’s labeling lacked adequate directions for all of lomitapide’s intended uses, the FDA said.
Quoting court documents, the FDA said that rather than following the REMS requirement to distribute lomitapide only for the narrow indication for which it was approved, Aegerion instead sought to render the diagnosis of homozygous familial hypercholesterolemia (HoFH), a rare disorder that that causes high cholesterol levels and early cardiovascular disease, as vague and indefinite as possible in order to extend the product use to additional patient populations.
Aegerion failed to give health care providers complete and accurate information about HoFH and how to properly diagnose it, the FDA said. Aegerion also filed a misleading REMS assessment report to the FDA in which the company failed to disclose that it was distributing lomitapide using a definition of HoFH that was inconsistent with Aegerion’s pre-approval filings with the FDA and that did not correspond to any peer-reviewed clinical standard for diagnosing HoFH. In addition, Aegerion management and sales personnel also distributed lomitapide not only for the treatment of HoFH, but also as a treatment for high cholesterol generally, without adequate directions for such use.
Sales representatives were trained to tell doctors and patients that lomitapide would “take patients out of harm’s way” and prevent “impending” heart attacks and strokes, despite the lack of data supporting those claims, prosecutors alleged. Numerous patients discontinued using lomitapide after suffering conditions including liver toxicity and gastrointestinal distress, prosecutors said.
The Justice Department said Aegerion’s promotion of lomitapide for patients without the genetic condition also led to false claims for payment to be submitted to government health care programs including Medicare. And the SEC alleged Aegerion misled investors by exaggerating how many new patients filled prescriptions for lomitapide.
The Justice Department said three ex-Aegerion employees who brought a whistleblower lawsuit against the company will receive $4.7 million as part of its civil settlement.
Aegerion and one of its senior vice presidents agreed to enter into a consent decree that includes a comprehensive compliance program and legal tools for the FDA to ensure that the defendants comply with the law, subject to judicial oversight, the FDA said.