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GlaxoSmithKline to Plead Guilty and Pay $3 Billion to Resolve Fraud Allegations and Failure to Report Safety Data

Global health care giant GlaxoSmithKline LLC (GSK) agreed to plead guilty and to pay $3 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of certain prescription drugs, its failure to report certain safety data, and its civil liability for alleged false price reporting practices, the Justice Department announced today.   The resolution is the largest health care fraud settlement in U.S. history and the largest payment ever by a drug company.

GSK agreed to plead guilty to a three-count criminal information, including two counts of introducing misbranded drugs, Paxil and Wellbutrin, into interstate commerce and one count of failing to report safety data about the drug Avandia to the Food and Drug Administration (FDA).   Under the terms of the plea agreement, GSK will pay a total of $1 billion, including a criminal fine of $956,814,400 and forfeiture in the amount of $43,185,600.   The criminal plea agreement also includes certain non-monetary compliance commitments and certifications by GSK’s U.S. president and board of directors.   GSK’s guilty plea and sentence is not final until accepted by the U.S. District Court.

GSK will also pay $2 billion to resolve its civil liabilities with the federal government under the False Claims Act, as well as the states.   The civil settlement resolves claims relating to Paxil, Wellbutrin and Avandia, as well as additional drugs, and also resolves pricing fraud allegations.

This resolution marks the culmination of an extensive investigation by special agents from HHS-OIG, FDA and FBI, along with law enforcement partners across the federal government. Moving forward, GSK will be subject to stringent requirements under its corporate integrity agreement with HHS-OIG; this agreement is designed to increase accountability and transparency and prevent future fraud and abuse. Effective law enforcement partnerships and fraud prevention are hallmarks of the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative, which fosters government collaboration to fight fraud.

Click here to view the DOJ press release: http://www.justice.gov/opa/pr/2012/July/12-civ-842.html

High Court Rules Data From FOIA Request Constitutes Public Disclosure Under False Claims Act

 In a ruling with implications for the health care industry, the U.S. Supreme Court May 16 ruled that information gathered through Freedom of Information Act (FOIA) requests constituted “public disclosures” and precluded recovery…

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Drugmaker Serono Agrees to Pay $44.3 Million to Settle Fraud Charges

Pharmaceutical manufacturer EMD Serono Inc. has agreed to pay $44.3 million to settle allegations it paid providers kickbacks to induce them to prescribe or promote its multiple sclerosis drug Rebif and that these payments resulted in the…

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SEC cool to corporate demands on whistleblowers

(Reuters) – U.S. securities regulators are resisting corporate America’s demands to force whistleblowers to report possible wrongdoing internally before they can be considered for compensation from regulators. The Securities and Exchange Commission’s whistleblower proposal, one of many rules required by the Dodd-Frank Wall Street overhaul law, would financially reward people who provide original substantive tips leading to enforcement actions that result in sanctions exceeding $1 million.

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DynCorp to Settle Claims of Inflating Costs for Iraq Work for $7.7 Million

DynCorp International Inc., the largest U.S. contractor in Afghanistan, agreed to pay $7.7 million to resolve allegations it submitted inflated claims for construction work in Iraq, the U.S. said.

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