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The fall season has been a particularly busy season for compliance, and the December issue of the Life Science Compliance Update reflects that. This month’s issue focuses on enforcement and the Government’s new push for individual accountability. We have articles on the Yates Memo with insights on it from Paul Kalb of Sidley Austin, as well as how the DOJ, FBI and OIG view it. In addition, we review both the new Sanofi Corporate Integrity Agreement (CIA), the Warner Chilcott settlements exploring the lessons to be learned. We also hear from a panel of five Chief Compliance Officers what life is like after the CIA ends. Finally, we have updates on key 1st Amendment and the Prevor combination products cases.
Table of Contents
EDITOR’S CORNER: Back to the Future Compliance Style
ENFORCEMENT: The Yates Memo: This seems all too familiar
ENFORCEMENT: The New Gilded Age of Individual Accountability – Views from the Enforcers
ENFORCEMENT: Sanofi (finally) signed their Corporate Integrity Agreement
ENFORCEMENT: How not to move the needle – Lessons from the Warner Chilcott Settlement
LEGISLATION: Bipartisan Budget Act Increases Civil Monetary Penalties
COMPLIANCE OPS: Speaking Frankly – Post CIA Insights from Five Chief Compliance Officers
FREE SPEECH: FDA v. the 1st Amendment – The Saga Continues
ORPHAN DRUGS: Strike Two – HRSA’s 340B Orphan Drug Policy Struck Down Again
MEDICAL DEVICES: Allowing Industry to Decide Its Own Regulatory Fate? Evaluating the Long-Term Significance of the Prevor Case