Juxtapid maker Aegerion Pharmaceuticals will shell out $36 million to resolve allegations that it violated federal marketing rules in promoting its cholesterol medication Juxtapid.
Aegerion agreed to a $7.2 million plea deal on criminal charges and a $28.8 million civil settlement, the Department of Justice announced Friday, resolving charges it pushed Juxtapid outside of the drug's FDA approval, violated risk-management regulations and broke antikickback laws with charity donations.
This isn't the first time Aegerion, now a subsidiary of Novelion, has faced a scandal on its key cholesterol drug. The biotech fired its CEO, Marc Beer, in 2015 for overhyping Juxtapid on CNBC's Fast Money. The segment led to an FDA warning letter and the DOJ later subpoenaed the drugmaker to learn about its marketing efforts.
Juxtapid won its U.S. approval in 2012 to help lower cholesterol in patients with homozygous familial hypercholesterolemia, a rare disorder, but U.S. officials said Aegerion sold the medication as a drug for high cholesterol generally.
Among the government's allegations are that the biotech filed a misleading Risk Evaluation and Mitigation Strategy report to the FDA, leaving out information about the definition of homozygous familial hypercholesterolemia it had been using to market Juxtapid. In a statement, FDA commissioner Scott Gottlieb said the company failed to live up to the requirements of the drug's approval.
"This is unacceptable," FDA commissioner Scott Gottlieb said. "We will continue to pursue those who skirt the law, and flout patient safety and other post-market commitments, using all of the enforcement tools available to us."
Aegerion merged with QLT to form rare disease drugmaker Novelion late last year. Juxtapid brought in $101 million in 2016 sales, Novelion reported (PDF), about two-thirds of the company's sales.