Life Science Compliance Update

September

2018

When Being First to Market Might Not be a Good Thing – Innovator Liability Rejected in West Virginia

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By Kaitlin Fallon Wildoner, Esq.

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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  • September

    2018

    A New Round of Efforts to Reform 340b: Part I, Program Transparency

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    By Gwendolyn Ball

    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.


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    September

    2018

    Catching A Glimpse – A Unique Look at Sanofi MS Subpoena For Potential AKS Violations

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    By Carolyn Greene, Esq.

    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.


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    September

    2018

    More Pain, Higher Up the Chain Is on The FCPA Enforcement Horizon

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    By: Michael Trahar

    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.


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    September

    2018

    Where Is the Grass Greener? Banking or Life Science Compliance Part II

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    By: Jenny McVey, Ph.D.

    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.


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  • August

    2018

    Ain’t Nobody Happy – New Jersey Attorney General Proposes Changes to Controversial Gift Regulation

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    By: Nicodemo Fiorentino

    In January 2018, a New Jersey regulation that regulates interactions between pharmaceutical manufacturers and prescribers went into effect. Now the Attorney General (“AG”) is proposing new amendments.


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    August

    2018

    The Year of The State – The Federal Right-To-Try Law Only Creates More Questions

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    By David Vulcano and John R. Brown

    Following on the heels of more than 40 state legislatures, the U.S. Congress passed a federal right-to-try law giving patients access to unapproved drugs outside of the standard clinical trial and Expanded Access system. Unfortunately, the new federal law only creates more questions, which this article explores.


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  • August

    2018

    State Laws Have Teeth – Minnesota Takes a Bite Out Of Insys

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    By Nicodemo Fiorentino

    In 1993, Minnesota became the first state to limit gifts and compensation provided by life science companies to healthcare providers. Now in 2018, with the advent of the Insys case, Minnesota is moving to enforce its statute. Although state law actions have been limited, this case is a reminder the state laws due have teeth requiring vigilance on the part of compliance professionals.


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  • August

    2018

    Swarming On The Opioid Crisis (Part 2): The DEA’s Quota System And Suspicious Order Monitoring Compliance Come Into Sharp Focus

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    By Katherine Norris

    This is the second article in the series exploring the major themes emerging from recent efforts to combat the ‘opioid crisis’ and their potential impact on drug manufacturers’ compliance programs. In this article, we explore the pressures facing the DEA to reduce diversion and the possibility of changes to the quota system.


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  • August

    2018

    Where Is the Grass Greener? Banking or Life Science Compliance

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    By: Jenny McVey, Ph.D.

    Considering both financial services and life science industries typically make it onto the top 10 list of most regulated industries in the U.S., can life science compliance professionals learn something new from banking compliance? This article explores that concept.


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    July

    2018

    Copay Assistance Lands Pfizer Another Corporate Integrity Agreement

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    Kaitlin Fallon Wildoner, Esq.

    Pfizer is the second company (of perhaps many) to find itself in a new corporate integrity agreement (CIA) over patient assistance programs and independent charities. The CIA entered between Pfizer and HHS-OIG, and the DOJ include some newer language and requirements centering around PAPs and give good insight into what other companies should be looking to do concerning their PAP arrangements.


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  • July

    2018

    When “Free” Really Isn’t Free – A Look at the Abiomed Case

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    Robert N. Wilkey, Esq.

    In March, the United State Department of Justice (DOJ) and U.S. Attorney’s Office for the District of Massachusetts announced a $3.1 million-dollar settlement with Abiomed to resolve allegations that the company was actively using illicit marketing tactics with physicians to increase sales in a manner that violated the AKS and FCA.  Such settlement highlights that there is no such as a free lunch.


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    July

    2018

    You Say Marketing Incentive; I Say Kickback – Former Valeant and Philidor Execs Convicted of Fraud in Kickback Scheme

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    Carolyn Greene, Esq.

    Former executives of Valeant Pharmaceuticals and Philidor Rx Services, a specialty pharmacy, recently went on trial in Manhattan charged with fraud and conspiracy for allegedly engaging in a kickback scheme in which the Valeant executive encouraged Valeant to purchase an option agreement to acquire Philidor. The Philidor executive allegedly personally obtained $40 million from the deal and paid an almost $10 million kickback to the Valeant executive. Both were convicted, and each faces a potentially lengthy prison term at sentencing. In recent years, the DOJ has stepped up enforcement in holding company executives personally liable for corporate malfeasance. However, before this case, the DOJ had little success in obtaining convictions in these cases.


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  • July

    2018

    Compliance Issues Can Scuttle A Deal – The Fresenius/Akorn Acquisition Seems to be the Latest Example

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    Gwendolyn Ball

    Compliance issues seldom take center stage in major financial deals.  However, the Fresenius/Akorn merger may be collapsing because of Akorn’s deficiencies in complying with FDA data management rules.  While it is not guaranteed that the courts will allow Fresenius to withdraw from the deal, Akorn has already suffered a very public blow to its reputation and a severe hit to its stock price.  The case illustrates how deficiencies in regulatory compliance can not only impact a firm’s relationship with regulatory agencies, but also its long-term financial and strategic planning.


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