Life Science Compliance Update

March

2017

COMMENTS

0

March 2017: Life Science Compliance Update

Written by , Posted in Home page, 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

Arrow

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

Arrow

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.

Arrow

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

Arrow

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.

Arrow

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.

Arrow

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.

March

2017

COMMENTS

0

March

2017

COMMENTS

0

Do DPA’s Work? – The BioMet Case Study

Written by , Posted in Enforcement

Robert N. Wilkey, Esq., LSCU Staff Writer

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.

March

2017

COMMENTS

0

Medical Devices & False Claims – Shire’s Settlement Is One for the History Books

Written by , Posted in Enforcement

Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update

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.

March

2017

COMMENTS

0

A Last Hurrah as CDRH Issues Guidances Before Obama’s Departure

Written by , Posted in FDA

Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update

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.

March

2017

COMMENTS

0

Using the Crystal Ball: What Does the Future Hold for Life Science Compliance?

Written by , Posted in Compliance Operations

Corey Hoze, J.D. Candidate, Mitchell Hamline School of Law (2018)

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.

March

2017

COMMENTS

0

Accountability: The shifting landscape of compliance responsibilities

Written by , Posted in Compliance Operations

Darren Jones, Managing Partner, Polaris Management Partners

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.

March

2017

COMMENTS

0

Privacy Regulation: The Final Frontier of Life Science Compliance

Written by , Posted in Feature Article

Matthew Gunzenhauser

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.

February

2017

COMMENTS

0

February 2017: Life Science Compliance Update

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

The full text of this issue is available to our subscribers. If you are a subscriber please log in now. If you are not a subscriber, and would like to become one, please click on the subscribe link or read about all of the benefits a subscription brings by clicking on the Subscribe menu item above.

February 2017 LSCU Cover

Issue Summary

This month we decided to look at both the compliance trends for 2017, as well as some of the “hot topics.” These hot topics include Patient Assistance Programs, Pharmaceutical Price Hikes and the new French anti-corruption law. We round out our coverage with the year-end enforcement highlights from the DOJ, OIG and FDA.


Feature

Arrow

Avoiding the Patient Assistance Program Spotlight
Kristin Rand, JD, MS, Compliance Officer, Seattle Genetics
Abstract

In efforts to understand the rising cost of some drugs Patient Assistance programs, particularly independent foundations, have become a focus of government investigations. This article explains what PAPs are, why they may be viewed as suspect and provides tips for providing patient assistance in a compliant manner.

Compliance Operations

Arrow

Product Price Hikes – When Business and Compliance Collide
Mark Scallon, Partner, FRA Life Sciences and Derek Patterson, Principal, FRA
Abstract

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.

Enforcement

Arrow

Anti-corruption: all roads lead to enforcement
Caroline Franco, Amy Greenstein, Darren Jones & Veronique Monjardet
Abstract

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.

Arrow

2017 Trending Towards a Banner Year for Industry Compliance
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
Abstract

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.

Arrow

Are the Safe Harbors Still Safe? – OIG Issues Final Rule
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
Abstract

The Department of Health and Human Services Office of Inspector General published a final rule, after considering various comments from stakeholders, about safe harbor provisions of the Anti-Kickback statute. This article goes into detail of what the changes were, and how they affect various health care providers.

Arrow

Valeant and Philidor Controversy Comes to a Head
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
Abstract

Valeant Pharmaceuticals, Inc. has had quite the year – they have been under scrutiny since October 2015. However, in November 2016, one former Valeant executive and one former Philidor executive, were arrested and charged with criminal complaints. This article outlines those complaints, and the actions the individuals allegedly took to be criminally charged.

Free Speech

Arrow

FDA’s Meeting on Promotion – Can We Glimpse the Future?
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
Abstract

In November, the FDA held a two-day Town Hall meeting to allow for input from stakeholders and patients surrounding agency regulation of manufacturer communications regarding unapproved uses of drugs and medical devices. This article provides a brief summary of the two-day event, including several presenters and their opinions.

Antitrust

Arrow

Antitrust and Generic Drugs – A Rare Combination
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
Abstract

Generic drug companies have been on the radar of the Department of Justice (“DOJ”) for several years, and recently the DOJ filed the first documents in the first suit against a generic drug manufacturer. Interestingly, they chose to start with a little-known company, after the company already went after the executives for racketeering charges. This article outlines several different actions focused on generic pharmaceutical manufacturers that are presently working their way through the courts.

February

2017

COMMENTS

0

Antitrust and Generic Drugs – A Rare Combination

Written by , Posted in Antitrust

Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update

Generic drug companies have been on the radar of the Department of Justice (“DOJ”) for several years, and recently the DOJ filed the first documents in the first suit against a generic drug manufacturer. Interestingly, they chose to start with a little-known company, after the company already went after the executives for racketeering charges. This article outlines several different actions focused on generic pharmaceutical manufacturers that are presently working their way through the courts.

February

2017

COMMENTS

0

FDA’s Meeting on Promotion – Can We Glimpse the Future?

Written by , Posted in Free Speech

Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update

In November, the FDA held a two-day Town Hall meeting to allow for input from stakeholders and patients surrounding agency regulation of manufacturer communications regarding unapproved uses of drugs and medical devices. This article provides a brief summary of the two-day event, including several presenters and their opinions.

February

2017

COMMENTS

0

Valeant and Philidor Controversy Comes to a Head

Written by , Posted in Abstract, Enforcement

Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update

Valeant Pharmaceuticals, Inc. has had quite the year – they have been under scrutiny since October 2015. However, in November 2016, one former Valeant executive and one former Philidor executive, were arrested and charged with criminal complaints. This article outlines those complaints, and the actions the individuals allegedly took to be criminally charged.

February

2017

COMMENTS

0

Are the Safe Harbors Still Safe? – OIG Issues Final Rule

Written by , Posted in Abstract, Enforcement

Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update

The Department of Health and Human Services Office of Inspector General published a final rule, after considering various comments from stakeholders, about safe harbor provisions of the Anti-Kickback statute. This article goes into detail of what the changes were, and how they affect various health care providers.

February

2017

COMMENTS

0

2017 Trending Towards a Banner Year for Industry Compliance

Written by , Posted in Enforcement

Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update

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.

February

2017

COMMENTS

0

Anti-corruption: all roads lead to enforcement

Written by , Posted in Enforcement

Caroline Franco, Amy Greenstein, Darren Jones & Veronique Monjardet

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.

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