Novelion Therapeutics subsidiary Aegerion Pharmaceuticals will pay more than $35 million to settle criminal and civil charges related to its cholesterol drug Juxtapid, the Department of Justice announced.
Juxtapid carries a warning label that explains it can cause serious liver and stomach issues and is only approved to treat high cholesterol in patients who have a rare genetic disease called homozygous familial hypercholesterolemia, or HoFH.
The United States alleged that from December 2012 to December 2015, Aegerion management sales staff violated the Federal Food, Drug, and Cosmetic Act by distributing Juxtapid as a general treatment for high cholesterol but did not provide adequate directions for such use.
Despite FDA had approval for Juxtapid's general use subject to a Risk Evaluation Mitigation Strategy to ensure that prescribers were informed of the drug's risks and preferred use for patients with a clinical or laboratory diagnosis consistent with HoFH, the government alleged Aegerion failed to give health care providers all necessary information regarding the clinical diagnosis of HoFH, which is a violation of REMS.
Aegerion has agreed to plead guilty to these charges and will pay a criminal fine and forfeiture of $7.2 million, the DOJ said.
A deferred prosecution agreement also resolved a felony charge that Aegerion conspired to violate HIPAA. Aegerion admitted to facts that show the company conspired with sales employees, including senior managers, to obtain patients' personally identifiable health information, without patient authorization, for commercial gain, according to the DOJ.
Per the terms of a civil False Claims Act settlement, Aegerion will pay $28.8 million over three years to resolve allegations that they distributed Juxtapid for patients without a diagnosis of, or consistent with, HoFH; made false and misleading statements to doctors that Juxtapid was appropriate for use in patients with high cholesterol, whether such patients had an HoFH diagnosis or not. Allegations also stated that Aegerion employees altered or falsified statements of medical necessity and prior authorizations submitted to federal healthcare programs, and even defrayed copayments for Juxtapid through a separate company, essentially making the drug free for patients, the DOJ said.
Aegerion entered into a five-year Corporate Integrity Agreement with the Office of Inspector General of the Department of Health and Human Services that requires that Aegerion implement compliance measures to ensure its promotional and other related activities comply with the law. It also requires reviews by an independent review organization and compliance-related certifications from company executives and Board members, among other things.