Aegerion Pharmaceuticals will plead guilty to charges concerning its prescription drug, Juxtapid, the Department of Justice announced on Friday. According to the Justice Department’s press release:
Aegerion introduced Juxtapid into interstate commerce that was misbranded because, among other things, Aegerion failed to comply with a Risk Evaluation and Mitigation Strategy (REMS). The resolution also includes a deferred prosecution agreement relating to criminal liability under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). In addition, Aegerion has agreed to settle allegations that it caused false claims to be submitted to federal health care programs for Juxtapid. Aegerion has agreed to pay more than $35 million to resolve criminal and civil liability arising from these matters. Aegerion has also agreed to enter into a civil consent decree of permanent injunction aimed at preventing future violations of the Federal Food, Drug, and Cosmetic Act (FDCA).
The Department of Justice said three ex-Aegerion employees, who brought a False Claims Act suit against Aegerion, will receive $4.7 million of the settlement proceeds. Under the qui tam provisions of the False Claims Act, whistleblowers, also known as relators, are able to sue on behalf of the government and are entitled to share in any recovery.
“Aegerion put profits over patient safety and enriched itself at taxpayer expense,” said Acting U.S. Attorney William D. Weinreb for the District of Massachusetts. “Our Office is committed to protecting patient safety and the integrity of federal health care programs, and we will continue to use our criminal and civil authority to ensure that drug companies play by the rules that protect the public, ensure quality of care, and preserve patient privacy.”
Aegerion also agreed to pay $4.1 million to settle a lawsuit brought by the SEC. The SEC alleged Aegerion misled investors by exaggerating the number of new patients filling prescriptions for Juxtapid. The settlements finalized agreements Aegerion disclosed in May 2016.
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