Life Science Compliance Update
Life Science Compliance Update is a monthly publication providing comprehensive, up-to-date compliance information for pharmaceutical, biotechnology, and device manufacturers. Each issue covers important news and analysis, with input from top compliance officers and healthcare attorneys across the industry.

November

2016

November 2016: Life Science Compliance Update

Written by , Posted in Home page, November 2016 LSC Update, This Month in Compliance

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November 2016 LSCU Cover

Issue Summary

This month pricing and whistleblowers dominate the compliance landscape. We heard a lot about how the Government wants to shift to value based contracts. What we haven’t heard much about is how these types of contracts will impact the established government pricing world. In the feature article this month, Chris Cobourn and Clay Willis of Huron Consulting explore the implications of value based contracts.

On the whistleblower front, we examine the implications of the SEC’s whistleblower guidance and the impact on FCA and FCPA enforcement. Matt Kelly, from Radical Compliance, takes it a step further looking at retaliation, pre-taliation, and whistleblower hotlines.

All this, plus the latest enforcement activities from the SEC, DOJ, OIG and FDA, round out our November issue!


Feature

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Value Based Contracts and Government Pricing – A Cross Functional View
Chris Cobourn, Managing Director and Clay Willis, Director Huron Life Sciences
Abstract

Value Based Contracts are becoming increasingly important and commonplace. VBCs also have important implications for Government Pricing programs. Therefore, life sciences companies need to take a coordinated and collaborative approach towards compliance that involves multiple stakeholders to evaluate the agreements and the potential impact on Government Pricing.

Enforcement

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SEC Provides Explicit Whistleblower Guidance – Hunting Season Is Now Open
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
Abstract

The SEC’s Office of the Whistleblower recently announced that its whistleblower awards have now exceeded over $100 million including resulting in the approximately $500 million regarding financial remedies in the form of SEC fines, forfeiture, and other penalties. The Program established by Congress to incentivize whistleblowers with specific, timely and credible information about federal securities laws violations to report to the SEC, continues to be a very integral part of the SEC’s overall enforcement and compliance plan.

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Examining the FY2015 Report on Medicaid Fraud Control Units
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
Abstract

Medicaid Fraud Control Units play an important, if often overlooked, role in the Government’s continuing effort to control program fraud and abuse. The recently released FY 2015 sheds light on the work of the Units as well as confirms trends seen by other enforcement agencies.

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GSK & China – The Latest FCPA Settlement Isn’t the End
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer for Life Science Compliance Update
Abstract

GlaxoSmithKline(“GSK”) reached a settlement with the Chinese government in 2014 related to bribes and improper actions taken by company officials. Recently, GSK reached an agreement with the United States Securities and Exchange Commission for allegations that GSK violated the FCPA. While the SEC settlement is nowhere near the value of the 2014 Chinese settlement, they are both worth taking a look at.

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Tracking Towards a Banner Year for FCPA and FCA Enforcement
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
Abstract

There are some strong indicators to suggest that 2016 is on track to be a real banner year regarding Foreign Corrupt Practices Act (“FCPA”) enforcement and qui tam actions. One of the most notable indicators is that FCPA enforcement for 2016 is on track to exceed actions for 2015, with to data, actions involving a total of 13 corporate and three individuals, including most significant the VimpelCom case. Additionally, newly unsealed qui tam cases show the FCPA focus on health care and hi-tech companies and the enforcement actions involving other countries, in particular, China is growing. This year is also an introduction to the DOJ’s pilot program.

Compliance Operations

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Retaliation, Pre-taliation, and Whistleblower Hotlines: How Compliance Officers Can Fight the Biggest Challenge They Face
Matt Kelly, Editor & CEO at Radical Compliance
Abstract

Handling whistleblowers is one of the biggest challenges facing most compliance officers. Furthermore, recent actions taken by the SEC are de facto policy pronouncements expanding the range of whistleblower risks compliance officers face. This article will review the three primary concerns that compliance officers have about whistleblowers: how to stop retaliation; how to avoid pre-taliation; and how to design whistleblower hotlines.

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The Dilemma of Co-Pay Charities and Patient Access to Medication
Lenna M. Babigian, M.H.S., Paralegal, LCSU Staff Writer
Abstract

Increasingly creative methods are being used by big pharma to increase sales. Drug manufacturers are donating billions of dollars to not-for-profit organizations that fund co-pay assistance programs for patients. Pharmaceutical company profits are through the roof and these not-for-profit organizations are growing at incredible rates. Even though patients are receiving much-needed financial help, there is an abundance of legal and ethical concerns.

FDA

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Are We Seeing the End of OPDP?
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
Abstract

The FDA OPDP issued enforcement letter have been on a steep decline since 2010. This article examines the numbers of OPDP letters issued, what they were issued for, and what it may mean for the compliance industry.

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