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The New Era of Regulatory Enforcement: A Comprehensive Guide for Raising the Bar to Manage Risk by Timothy P. Hedley, Richard H. Girgenti

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Chapter 11

Fraud and Misconduct in Life Sciences

Mark C. ScallonRegina G. CavaliereRichard L. Zimmerer

Since the early 2000s, corporations and individuals in the life sciences industry have been the subject of heightened scrutiny and intensified regulatory enforcement for their alleged involvement in bribery and corruption, unlawful marketing practices, and research fraud. Since 2001, more than 35 pharmaceutical and biotechnology manufacturers and medical device companies have settled allegations with the U.S. government, many of them paying hefty fines and entering into expansive corporate integrity agreements (CIAs). For each fiscal year between 2009–2014, the U.S. government has recovered more than $2 billion from the life sciences industry. ...

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