Life Science Compliance Update

September

2018

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.


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Where Is the Grass Greener? Banking or Life Science Compliance Part II
By: Jenny McVey, Ph.D.
Tags: , ,
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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More Pain, Higher Up the Chain Is on The FCPA Enforcement Horizon
By Michael Trahar
Tags: , , ,
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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Catching A Glimpse – A Unique Look at Sanofi MS Subpoena For Potential AKS Violations
By Carolyn Greene, Esq.
Tags: , , ,
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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A New Round of Efforts to Reform 340b: Part I, Program Transparency
By Gwendolyn Ball
Tags: , ,
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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When Being First to Market Might Not be a Good Thing – Innovator Liability Rejected in West Virginia
By Kaitlin Fallon Wildoner, Esq.
Tags: , , ,
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.

September

2018

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

Written by , Posted in Uncategorized

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

    Written by , Posted in Uncategorized

    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

    Written by , Posted in Uncategorized

    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

    Written by , Posted in Uncategorized

    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

    Written by , Posted in Uncategorized

    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

    Written by , Posted in Uncategorized

    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

    Written by , Posted in Uncategorized

    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

    Written by , Posted in Uncategorized

    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

    Written by , Posted in Uncategorized

    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

    Written by , Posted in Uncategorized

    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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    August

    2018

    August 2018: Life Science Compliance Update

    Written by , Posted in August 2018 LSC Update

    The full text of the entire issue is now available to our subscribers. If you are a subscriber please log in now. You may also buy this issue by clicking on the button below.


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    August 2018 Issue Free Article

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    SPECIAL SUPPLEMENT: Adapt or Perish: Can Stem Cell Therapies Achieve Their Potential for Delivering Optimal, Cost-Effective Clinical Outcomes in An Evolving Regulatory Framework?
    By George Schroeder, M.D. M.S., FACEP.; Seth Whitelaw, J.D., LL.M., S.J.D and Helmut Makosch, M.Sc.

    August 2018 Issue Summary

    August 2018 LSCU Cover

    This month we begin with a comparison of compliance between the FINANCIAL SERVICES and life sciences industry with particular emphasis on the ROLE of the BOARD OF DIRECTORS in directing compliance activities. Next, we shift back to the OPIOID crisis with a follow-on article examining the DEA QUOTA SYSTEM and potential changes. That is followed by a look at the latest TRANSPARENCY ENFORCEMENT action by MINNESOTA against INSYS. In our Updates, Shorts & Briefs section, we continue with TRANSPARENCY and look at the new PROPOSED CHANGES to the NEW JERSEY GIFT BAN.

    Moving on to RESEARCH, we start with a run-down of federal and state RIGHT-TO-TRY LAWS and their potential impact on established FDA protocols such as COMPASSIONATE USE. In this issue we also are including a special supplement devoted to the rapidly growing field of STEM CELL THERAPIES and the inevitable conflict with the established regulatory framework.  Finally, and by no means least, come hear our esteemed publisher, TOM SULLIVAN, discuss the TRENDS from four full years of OPEN PAYMENTS DATA at the upcoming 12th ANNUAL FORUM ON TRANSPARENCY AND AGGREGATE SPEND on August 22nd.  If you have never heard Tom speak about Open Payments data before, you are in for a treat!


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    Where Is the Grass Greener? Banking or Life Science Compliance
    By: Jenny McVey, Ph.D.
    Tags: ,
    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.

    Arrow

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

    Arrow

    State Laws Have Teeth – Minnesota Takes a Bite Out Of Insys
    By Nicodemo Fiorentino
    Tags: , , , ,
    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.

    Arrow

    The Year of The State – The Federal Right-To-Try Law Only Creates More Questions
    By David Vulcano and John R. Brown
    Tags: , , ,
    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.

    Arrow

    Ain’t Nobody Happy – New Jersey Attorney General Proposes Changes to Controversial Gift Regulation
    By Nicodemo Fiorentino
    Tags: , ,
    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.

    July

    2018

    July 2018: Life Science Compliance Update

    Written by , Posted in July 2018 LSC Update, This Month in Compliance

    The full text of the entire issue is now available to our subscribers. If you are a subscriber please log in now. You may also buy this issue by clicking on the button below.


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    July 2018 Issue Free Article

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    Copay Assistance Lands Pfizer Another Corporate Integrity Agreement
    By 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.

    July 2018 Issue Summary

    July 2018 LSCU Cover

    If you are looking for a theme for this month, we suggest PAIN. From the opioid crisis to patient copay assistance it seems that despite our best compliance efforts there is no shortage of programs and antics that are resulting in painful outcomes for life science companies.

    Speaking of pain, we lead off this month with Katherine Norris’s article on the current swarm of legislation to address the OPIOID CRISIS that is occupying CAPITOL HILL this summer. Following that is an article chronicling CANTRELL DRUG COMPANY’S FIVE-YEAR SAGA with the FDA and now the DOJ for CGMP issues at its COMPOUNDING facility.

    Next, we take a look how compliance issues can impact a potential MERGER, especially when serious allegations of non-compliance, especially involving DATA INTEGRITY, come to light after the DUE DILIGENCE process. The court documents in the FRESENIUS/AKORN case give us a rare glimpse into that world.

    Moving into the more familiar territory of kickbacks and false claims, we examine the VALEANT and PHILIDOR case which resulted in CRIMINAL CONVICTIONS for executives from both a Valeant and a Philidor. Then there is the Abiomed settlement which involved using expensive meals as inducements 15 years after the PhRMA code. Finally, we wrap it up with a look at Pfizer’s most recent CORPORATE INTEGRITY AGREEMENT involving one of the latest hot button items – PATIENT ASSISTANCE PROGRAMS and INDEPENDENT COPAY CHARITIES.


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    Swarming on the Opioid Crisis: Legislative Response Attacks Concerns from All Sides
    Katherine Norris
    Tags: ,
    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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    The Sleeping Giant Awakens – Cantrell’s Consent Decree as a Study on How Not to Respond to FDA Enforcement Actions
    Carolyn Greene, Esq.
    Tags: , ,
    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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    Compliance Issues Can Scuttle A Deal – The Fresenius/Akorn Acquisition Seems to be the Latest Example
    Gwendolyn Ball
    Tags: , ,
    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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    You Say Marketing Incentive; I Say Kickback – Former Valeant and Philidor Execs Convicted of Fraud in Kickback Scheme
    Carolyn Greene, Esq.
    Tags: , ,
    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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    When “Free” Really Isn’t Free – A Look at the Abiomed Case
    Robert N. Wilkey, Esq.
    Tags: , ,
    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.

    July

    2018

    Copay Assistance Lands Pfizer Another Corporate Integrity Agreement

    Written by , Posted in Uncategorized

    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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