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.

February

2017

February 2017: Life Science Compliance Update

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

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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

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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

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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

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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.

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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.

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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.

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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

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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

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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.

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