Life Science Compliance Update

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January 19, 2018

Christmas Comes Early - The FCPA Pilot Program Made Permanent

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When we first introduced the FCPA Pilot Program in the June 2016 issue, we noted the uncertainties of outcomes for companies who voluntarily self-disclose potential violations. On November 29, 2017, Deputy Attorney General Rod Rosenstein announced that the US Department of Justice (DOJ) had made the FCPA Pilot Program permanent. This article will review some of the key highlights outlined by the DOJ and some considerations for compliance professionals.

The heat is on life science companies. Since 2013, there have been 25 Foreign Corruption Practices Act (“FCPA”) matters involving life science companies, 13 of which occurred in the last two years. Although life science companies have not been immune to FCPA investigations in the past, the statement of Acting Chief of the U.S. Department of Justice (“DOJ”) Fraud Section, Sandra Moser in August was loud and clear - the DOJ would be increasing its enforcement efforts of healthcare related companies.

We reviewed the outcomes of the FCPA Pilot Program (“Pilot Program”) in the September 2017 issue of the Update, examining the benefits of self-disclosure under the program. Now, a year since its inception, the DOJ has announced that the Pilot Program will now be permanent.

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