Life Science Compliance Update

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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January 17, 2018

Like the Little Drummer Boy, the Beat Goes on as OIG Enforcement Shows Few Signs of Letting Up

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As life science compliance professionals know, it is important to monitor what the HHS OIG focuses on. This article reviews the OIG’s focus in 2017 and looks ahead to what may be in store for 2018.

For life science compliance professionals, following the activities of the Office of Inspector General (“OIG”) for the Department of Health and Human Services is both a question of curiosity and necessity. With the limited amount of formal guidance available, the OIG’s actions provide vital clues as to the agency’s thinking and focus in the near future.

As we closed out 2017, two overarching themes emerged. The first was the need to invest in internal auditing and measurement of compliance programs, and the second the advent of more coordinated investigations involving pain management drugs. For 2018, as discussed below, we believe both themes will continue with the OIG being hyper-focused on anything involving opioids and pain management.

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January 15, 2018

A Compliance New Year’s Resolution – Assess the Company’s Culture

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The topic of ‘company culture’ is certainly not new, but it continually emerges as a hot topic within regulatory circles. An organization’s culture is recognized to exert a powerful influence on how a company and its people conduct business. Although there is an inherent understanding that by continually enhancing company culture, ethical aspects of the organization will follow suit, why isn’t culture reviewed with the same rigor and principles that are required for compliance programs? This article will discuss the importance to evaluate an organization’s culture of compliance, and will introduce some considerations on how this can be done.

At the start of every New Year, we hear people discussing, exchanging, making and breaking New Year’s resolutions. Why should the company compliance program be any different? Frankly, we do not think it should. Therefore, for 2018, we propose that assessing the company’s culture top the compliance New Year’s resolution list.

Here are a couple of reasons why culture assessment should top the list.

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