Drug Maker Aegerion Agrees to Plead Guilty; Will Pay More Than $35 Million to Resolve Criminal Charges and Civil False Claims Allegations
Drug Maker Aegerion Agrees to Plead Guilty; Will
As charged in a criminal information filed today, 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
"Today's settlement shows that the government will continue to hold accountable drug companies that violate laws designed to protect the health and safety of patients," said Acting Assistant Attorney General
In a criminal information filed on
The information alleges that during the relevant time period, Aegerion failed to give health care providers complete and accurate information about HoFH and how to properly diagnose it, and that Aegerion also filed a misleading REMS assessment report.According to the information, Aegerion therefore failed to comply with the required elements under the REMS to assure safe use of Juxtapid, in violation of the FDCA.The information further alleges that Aegerion management and sales personnel distributed Juxtapid not only for the treatment of HoFH, but also as a treatment for high cholesterol generally, without adequate directions for such use.Under the terms of a plea agreement, Aegerion has agreed to plead guilty to these charges and pay a criminal fine and forfeiture of
In a deferred prosecution agreement to resolve a felony charge that Aegerion conspired to violate HIPAA, 42 U.S.C. S.S. 1320d-6(a) and 1320-6(b)(3), Aegerion admitted that it conspired to obtain patients' personally identifiable health information, without patient authorization, for commercial gain.Under the terms of the deferred prosecution agreement, Aegerion will implement enhanced compliance provisions, including periodic certifications to the government concerning its implementation of those provisions.
Under the civil false claims settlement, Aegerion will pay
"Aegerion put profits over patient safety and enriched itself at taxpayer expense," said Acting
As part of the resolution, Aegerion has agreed to enter into a separate civil consent decree to resolve civil liability under the FDCA in connection with its failure to comply with the requirements of the Juxtapid REMS program and its distribution of Juxtapid with labeling that lacked adequate directions for all of Juxtapid's intended uses.Aegerion also entered into a Corporate Integrity Agreement (CIA) with the HHS-OIG.The five-year
"We sometimes require companies to put in place certain measures to more closely manage a drug's risks when we don't believe a medicine's benefits would outweigh its side effects without these risk mitigation strategies," said FDA Commissioner
"Today's plea and settlement with Aegerion shows how the government will hold the pharmaceutical industry accountable for violating important
"Our corporate integrity agreement increases individual accountability for board members and company executives and it requires Aegerion to strengthen controls around promotional activities and other interactions with health care providers," said Chief Counsel to the
"Today's agreement demonstrates that we will not allow pharmaceutical manufacturers to provide the medical community with false and incomplete information about their products, thereby jeopardizing the health and safety of our citizens," said Special Agent in Charge
The civil false claims settlement resolves a lawsuit filed by
The government's resolution of this matter illustrates the government's emphasis on combating health care fraud.One of the most powerful tools in this effort is the False Claims Act.Tips and complaints from all sources about potential fraud, waste, abuse, and mismanagement can be reported to the
This resolution was the result of a coordinated effort by the
Except as to conduct admitted as part of the guilty plea and deferred prosecution agreement, the claims resolved by the civil settlement are allegations only and there has been no determination of liability.
Attachment(s):
Topic(s):
False Claims Act
Component(s):
Civil Division (http://www.justice.gov/civil/)
DOJ - USAO
Press Release Number:
17-1044
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