Aegerion Pharmaceuticals Inc. has agreed to pay $40 million and plead guilty to two misdemeanor charges to settle federal allegations of improperly marketing a pricey cholesterol drug and violating federal laws.
Specifically, the Cambridge company failed to market Juxtapid, which costs about $250,000 a year and is used to treat a rare form of high cholesterol, with adequate directions. The settlement also notes that the drug maker failed to comply with the terms of a mandatory program for ensuring that the risks of taking the medicine are followed by doctors and patients.
In a statement announcing the settlement, Aegerion acknowledged obstructing justice concerning the risk-management program and violating both the Health Insurance Portability and Accountability Act and the False Claims Act. The specific nature of the violations was not disclosed.
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The settlement was reached with the Department of Justice and the Securities and Exchange Commission. The drug maker noted that under preliminary terms of the settlement, it will not be excluded from doing business with federal health care programs, such as Medicaid and Medicare.
Nearly a year ago, Aegerion’s chief executive, Marc Beer, resigned amid controversy over comments he made about Juxtapid during two appearances on CNBC’s “Fast Money” television show in 2013. In one episode, Beer said that “patients are going to die of a cardiac event, either a stroke or a heart attack, if we don’t have them on therapy.”
The remarks raised the ire of the Food and Drug Administration, which warned the company that they “misleadlingly” suggested the drug could reduce cardiovascular events and prolong life.
The FDA’s approval of the drug was based on data showing that the pill lowers cholesterol levels in people with a rare genetic disease, familial homozygous hypercholesterolemia. But the company did not submit data showing its drug lowered the risk of a heart attack or death.
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In January 2014, the Justice Department subpoeanaed company documents regarding its marketing and sale of Juxtapid.
Aegerion and Beer are currently defendants in a class-action lawsuit brought by shareholders, who claimed his remarks damaged the value of Aegerion stock.
Ed Silverman can be reached at ed.silverman@statnews.com.
Follow Ed on Twitter @Pharmalot