Judge that nixed Juxtapid's DOJ settlement prompts Aegerion to admit its off-label sins

judgement fine regulatory hammer
Judge William Young, who rejected Aegerion's proposed $36 million settlement on Juxtapid marketing, set up a deal to include patient restitution in the company's payments. (Image: Pixabay)

Aegerion agreed to pay almost $36 million to the feds in a Juxtapid off-label marketing case, but a federal judge thought that wasn't good enough. Tuesday, he sentenced the company to pay the same total—only this time, patients got a chunk of the settlement.

“I feel so strongly that people who were harmed by this criminality ought to have some recompense,” U.S. District Court Judge William Young said, as quoted by the Boston Globe.

Rather than paying the entire amount to the federal government, Aegerion will hand over $7.2 million of it to patients who used Juxtapid for a condition it wasn't FDA-approved to treat. According to a company statement, the company's overall Juxtapid marketing penalties amount to $40.1 million, including payments to the state and the Securities & Exchange Commission.

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RELATED: Shire to fork over $350M to settle 'flagrant' Dermagraft kickback claims

Now merged with Novelion Therapeutics, Aegerion swept out its management team and hired new salespeople after the Justice Department launched its marketing investigation, the Globe reports, citing court documents. During the sentencing hearing, Novelion COO Jeffrey Hackman said the company overstepped the rules and accepted responsibility for its former employees' violations. 

“We accept complete responsibility for this conduct,” Hackman said, as quoted by the Globe. “It never should have occurred and we strive to ensure that it never occurs again.”

In the scheme of off-label marketing settlements, $36 million is quite small, but then again, Juxtapid isn't the sort of blockbuster drug subject to prior marketing allegations. Novelion estimated 2017 sales at just $85 million max, down from a pro forma $101 million in 2016, according to the company's most recent financial presentation.

RELATED: Pharma's Top 11 Marketing Settlements

Most recent settlements in that arena have been in the double digits, however, including Allergan's $13 million deal to settle kickback claims related to its eye drugs and Novo Nordisk's $60 million settlement of claims that sales reps downplayed risk-management requirements on its diabetes blockbuster Victoza. But Celgene agreed to pay $280 million to wrap up marketing claims on its biggest-selling drug, Revlimid, and Shire said it would shell out $350 million to wrap up Dermagraft marketing allegations.

In its Tuesday statement, Novelion called the sentence an "important milestone" that allows it to focus on its business going forward. "As a company, we are deeply committed to legal and regulatory compliance," Chairman Jason M. Aryeh said. "We have worked tirelessly to build a culture of integrity and ethics under our new management team and board of directors, in an effort to put legacy Aegerion challenges behind us."

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