Second Circuit Deals Blow to Off-Label Marketing Claims

On May 17, the United States Court of Appeals for the Second Circuit affirmed the dismissal of a relator’s False Claims Act (FCA) claims predicated on allegations that Pfizer “improperly marketed Lipitor, a popular statin, as appropriate for patients whose risk factors and cholesterol levels fall outside the National Cholesterol Education Program (NCEP) Guidelines.”

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Medical Device Alert – Political Agreement Concerning the Text of the New Regulations On Medical Devices and in Vitro Diagnostic Medical Devices

Late on 25 May 2016, the Council of the European Union issued a press release to announce that the European Commission, the European Parliament and the Council had reached a political agreement concerning the text of the proposed Regulation on medical devices and the proposed Regulation on in vitro diagnostic medical devices.

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Dept. of Energy Proposes DEAR Amendment to Clarify the Nondisplacement of Qualified Workers Under Service Contracts Regulation

Recently, the Department of Energy (DOE) released a Federal Register notice proposing an amendment to the DOE Acquisition Regulation (DEAR) to clarify Federal Acquisition Regulation (FAR) Subpart 22.12, Nondisplacement of Qualified Workers Under Service Contracts.

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Federal Agencies’ Proposal Would Require Some Government Contractors to Report Whether They Publicly Disclose Greenhouse Gas Emissions and Reduction Goals

Today, the Department of Defense (“DoD”), General Services Administration (“GSA”), and the National Aeronautics and Space Administration (“NASA”) (collectively, the “FAR Council”) proposed amendments and revisions to the Federal Acquisition Regulation (“FAR”) that would require some government contractors to indicate whether they publicly disclose greenhouse gas (“GHG”) emissions and/or quantify corporate GHG reduction goals.

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