Life Science Compliance Update

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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    July

    2018

    The Sleeping Giant Awakens – Cantrell’s Consent Decree as a Study on How Not to Respond to FDA Enforcement Actions

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    Carolyn Greene, Esq.

    Cantrell Drug Company, a 503B outsourcing facility in Little Rock, Arkansas, has been subject to multiple FDA inspections over a five-year period. Each inspection found numerous deficiencies, many in critical areas relating to the prevention of microbiological contamination and aseptic processing. Cantrell defied FDA instructions and shipped products in interstate commerce. As a result, FDA referred the matter to the DOJ, which filed a civil enforcement proceeding seeking to enjoin Cantrell from further distribution. Ultimately, Cantrell entered into a consent decree with the FDA. This case played out much more publicly than similar situations, as Cantrell executives were posting comments on Twitter about the process. Unfortunately, the tone of the comments suggested that Cantrell did not take the FDA’s supervision seriously.


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    July

    2018

    Swarming on the Opioid Crisis: Legislative Response Attacks Concerns from All Sides

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    Katherine Norris

    This is the first article in a series exploring the major themes emerging from recent legislative efforts to combat the ‘opioid crisis’ and their potential impact on drug manufacturers’ compliance programs. Currently, there is a myriad of bills before the U.S. Congress attempting to address the growing epidemic of opioid abuse, misuse, and diversion throughout the United States.


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    July

    2018

    July

    2018

    LSCU Free Articles

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    June

    2018

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