Life Science Compliance Update

February 20, 2017

2017 Trending Towards a Banner Year for Industry Compliance

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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

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February 17, 2017

Anti-corruption: All roads lead to enforcement

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When it comes to corruption, Life Sciences companies are a frequent target of investigation and enforcement. The French enactment of Sapin II is the latest in a long line of laws to combat corruption. This article explores Sapin II and why the authors feel that Life Sciences companies are among the best positioned to comply with Sapin II’s requirements.

Corruption occurs across all industries – from banking and finance to energy and mining – however, Life Sciences companies are frequently under the microscope due to a variety of circumstances unique to the industry. Among these circumstances are the fact that:

  1. Customers and influencers of prescription drug use are often public officials (i.e. HCPs can be government employees or work at public institutions),

  2. Company-sponsored event objectives can be unclear (i.e. whether a sponsored event or engagement is related to scientific exchange or is promotional/ commercial in nature),

  3. There is a heavy reliance on third parties and sub- contractors who are responsible for engaging with government officials and employees, and relatedly, and

  4.  Complex supply chains and distribution channels typically span all corners of the globe.

    Read the full article in the February 2017 issue of Life Science Compliance Update

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February 15, 2017

Product Price Hikes - When Business and Compliance Collide

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2016 was the year of the price increase, as leading industry players experienced significant public outrage over what appeared to be extreme price increases. What is compliance’s role when it comes to price increases? Does the ethics and compliance function get to weigh in on how decisions to raise the prices of products are reached, or does this function lie solely with the business? This article explores those questions.

It is safe to say that in the life sciences regulatory world, 2016 was the year of the price increase, as leading industry players experienced significant public outrage over what appeared to be extreme price increases. 

Investigations, subpoenas and congressional hearings led to settlements and fines, as in early December 2016, Pfizer was charged a record £84.2 million fine by the UK’s Competition and Markets Authority (CMA) for the overnight price increase of 2,600% for an epilepsy drug. The CMA did not stop there, and went further to also fine the distributor Flynn Pharma £5 million for its part in the pricing scheme. Although Pfizer is currently appealing the findings, it is alleged that prices for the drug in the UK were many times higher than elsewhere in Europe and that “the companies deliberately exploited the opportunity offered by de-branding to hike up the price for a drug which is relied upon by many thousands of patients”. CMA added that “these extraordinary price rises have cost the NHS and the taxpayer tens of millions of pounds”.

Read the full article in the February 2017 issue of Life Science Compliance Update

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