Life Science Compliance Update
Policy & Medicine Compliance Update, formerly 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.



September 2018: Policy & Medicine Compliance Update

Written by , Posted in Home page, September 2018 LSC Update, This Month in Compliance

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September 2018 Issue Summary

September 2018 LSCU Cover

This month we begin with the fact that we have a new name. It is my great pleasure to announce that going forward the LIFE SCIENCE COMPLIANCE UPDATE is combining forces with POLICY & MEDICINE with a new name and eventually a new website. With a nod to both our past and our future, our new name is POLICY & MEDICINE COMPLIANCE UPDATE, and this change we are now are truly part of the P&M family. Therefore, let me welcome all of you to the inaugural issue of POLICY & MEDICINE COMPLIANCE UPDATE and to our bright future!

Building from last month’s article comparing compliance between the FINANCIAL SERVICES and LIFE SCIENCES, this month continue with PART II examining how banks ORGANIZE their COMPLIANCE FUNCTIONS.

On the enforcement front, we get a look at the potential increase in FCPA ENFORCEMENT as the DOJ expects more effort from SENIOR MANAGEMENT to combat bribery and corruption. Next, we look at the recent DOJ SUBPOENA for SANOFI around the marketing of MS DRUGS, followed by an article about the efforts to reform the 340B DISCOUNT PROGRAM by increasing TRANSPARENCY. Finally, not forgetting the importance of the plaintiff’s bar, we examine a novel plaintiff’s GENERIC PHARMACEUTICAL product LIABILITY theory called INNOVATOR LIABILITY.


Where Is the Grass Greener? Banking or Life Science Compliance Part II
By: Jenny McVey, Ph.D.
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In the August issue of the Update, we discussed key regulatory mandates that large banks are expected to adhere to. Although the overall principles of banking compliance mirror that of the life science industry, there is a concerted emphasis around the engagement, responsibility, and accountability of a bank’s Board of Directors, which is unseen within life sciences. This article discusses how large banks operationalize regulatory mandates by reviewing the organizational structure of a compliance function within a bank.


More Pain, Higher Up the Chain Is on The FCPA Enforcement Horizon
By Michael Trahar
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Growing reliance on third parties to administer the touchpoints between life sciences companies and foreign officials risks criminal liability for enterprises and individuals high in management, if regulators view the third-party contracts as designed to facilitate corruption. Lessons learned from past enforcement actions and improved compliance policies mean these contracts are approved at ever-higher levels of management, but revenue flows through third parties are becoming less transparent.


Catching A Glimpse – A Unique Look at Sanofi MS Subpoena For Potential AKS Violations
By Carolyn Greene, Esq.
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In response to media reports of sensational drug prices, the DOJ has launched investigations into marketing practices, issuing subpoenas to many pharmaceutical companies. Sanofi reported that it was recently subpoenaed about its marketing practices as to two of its MS drugs, Lemtrada and Aubagio. In an unfortunate turn of events for Sanofi, someone leaked Sanofi’s Legal Hold notice written in response to the DOJ subpoena. The Legal Hold notice provides unique insight into the types of marketing practices that the DOJ is investigating, including strategies relating to patient charities, PAPs and other areas where healthcare providers receive some kind of remuneration.


A New Round of Efforts to Reform 340b: Part I, Program Transparency
By Gwendolyn Ball
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Ever since the creation of the 340B discount program, it has been plagued by transparency issues. Current efforts to curb pharmaceutical prices have only served to resurface these unresolved issues. This article, the first of two parts, will explore the latest developments to address 340B transparency.


When Being First to Market Might Not be a Good Thing – Innovator Liability Rejected in West Virginia
By Kaitlin Fallon Wildoner, Esq.
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Innovator liability is a somewhat novel approach some plaintiff attorneys are using in an attempt to hit the brand-name pharmaceutical industry where it hurts – in their pocketbooks. This article outlines the concept of innovator liability, its intended purpose, and why brand-name manufacturers need to keep an eye on trends in this space.
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