There are strong indications that 2017 is already trending towards a banner year for industry compliance, including most notably the continued and active efforts by the U.S. Department of Justice (“DOJ”), U.S. Securities and Exchange Commission (“SEC”) and other government agencies, to investigate, prosecute, and settle with life science companies for issues related to noncompliance, lack of transparency, and the falsification of science based data. There are also a few pending investigations by the DOJ involving various generic drug companies, including allegations of illegal pricing agreements and collusion, which will similarly impact compliance in 2017.
Throughout the Presidential campaign cycle and now in Donald Trump’s January 11, 2017, news conference, we have heard mixed messages about the incoming administration’s stance on enforcement and regulation. Trump, himself, has vacillated between a laissez-faire position and demonizing the pharmaceutical industry. However, regardless of the political rhetoric, the underlying fundamentals, and key indicators strongly suggest that 2017 will be remarkable regarding regulatory industry compliance. Those indicators are 1) the level of government oversight, specifically among the DOJ/SEC and other government agencies; 2) the industry emphasis on corporate governance, reforms, and transparency; and 3) pending investigations and enforcement actions. Therefore, although the Trump Administration’s impact on the preceding remains somewhat uncertain, given that 2016 has experienced a significant upswing in compliance activity, it is anticipated that 2017 will follow.
Read the full article in the February 2017 issue of Life Science Compliance Update.