Life Science Compliance Update

March

2017

March 2017: Life Science Compliance Update

Written by , Posted in March 2017 LSC Update, This Month in Compliance

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March 2017 LSCU Cover

Issue Summary

It’s March madness for Life Science Compliance. Medical devices are our focus this month. First, we highlight at all the new FDA device guidances issued when Obama departed the White House. We also look at how the FCA can impact devices with the Shire settlement. Also on the enforcement front, we explore whether DPA’s work as intended, as well as dive into the FY 2016 FCA recovery numbers. We finish up with two articles from Mitchell Hamline law students, Matthew Gunzehauser and Corey Hoze and one from Darren Jones of Polaris Management Partners on the future of life science compliance.


Feature

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Privacy Regulation: The Final Frontier of Life Science Compliance
Matthew Gunzenhauser
Abstract

Recently, as part of the course Legal Compliance Essentials for Drug, Device and Biotech Companies, Mitchell Hamline Law School, students were asked to write about what they saw as the important emerging issues for life sciences and what compliance professionals will need to do to adapt. Here is the first in a two-part series.

Compliance Operations

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Accountability: The shifting landscape of compliance responsibilities
Darren Jones, Managing Partner, Polaris Management Partners
Abstract

The meaning of effectiveness of healthcare compliance programs has shifted in recent years. This article examines that shift and what it means for the role of the Compliance Officer including the need to evaluate and oversee a portfolio of risks.

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Using the Crystal Ball: What Does the Future Hold for Life Science Compliance?
Corey Hoze, J.D. Candidate, Mitchell Hamline School of Law (2018)
Abstract

Recently, as part of the course Legal Compliance Essentials for Drug, Device and Biotech Companies, Mitchell Hamline Law School, students were asked to write about what they saw as the important emerging issues for life sciences and what compliance professionals will need to do to adapt. Here is the second in the two-part series.

FDA

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A Last Hurrah as CDRH Issues Guidances Before Obama’s Departure
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
Abstract

In a last-minute attempt to put a permanent mark on the life sciences (and specifically, the medical device) industry, the outgoing Obama Administration issued a litany of final and draft guidances in a roughly six-week period. This article briefly reviews these new guidance documents.

Enforcement

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Medical Devices & False Claims – Shire’s Settlement Is One for the History Books
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
Abstract

We have seen many large False Claims and Anti-kickback settlements with pharmaceutical companies and the prescriptions they manufacture. Now, a medical device company has gotten into difficulty for many of the same types of violative activities. This article provides an overview of the allegations and the settlement.

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Do DPA’s Work? – The BioMet Case Study
Robert N. Wilkey, Esq., LSCU Staff Writer
Abstract

On January 12, 2017, the U.S. Department of Justice (DOJ) announced publicly that Zimmer Biomet Holdings, Inc. (Zimmer BioMet) had agreed to pay a $17.4 million criminal penalty “in connection with a scheme to pay bribes to government officials in Mexico and for violations of the internal controls provisions of the Foreign Corrupt Practices Act (FCPA) involving the company’s operations in Mexico and Brazil.” This is not the first time BioMet faced allegations involving its business practices in foreign countries, and in 2012 entered a deferred prosecution agreement (DPA). The BioMet settlement highlights the significant liability life health science companies face when failing to adhere to DPAs and how large-scale settlements are used by the government to ensure industry compliance.

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DOJ Has Third Highest Annual Recovery in FCA History
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
Abstract

The United States Department of Justice has announced the fiscal year 2016 recoveries from civil False Claims Act. This article delves into the numbers, extracting those recoveries.

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