Life Science Compliance Update

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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    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

    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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  • June

    2018

    Maryland Loses Rx Price Gouging Law But Not The Debate

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    Nicodemo (Nico) Fiorentino, Esq.

    Recently the United States Court of Appeals for the Fourth Circuit overturned Maryland’s law prohibiting price gouging for essential off–patent or generic drugs. This article highlights Maryland’s first-in-the-nation prescription drug price gouging legislation, key points to the commerce clause, and the impact the court’s ruling has on similarly proposed legislation throughout the country.


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    April

    2018

    The Day After Tomorrow – The Drug Pricing Transparency Chorus Grows Louder

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    Nicodemo Fiorentino, Esq. and Seth B. Whitelaw, J.D., LL.M., S.J.D.

    Drug pricing transparency, as a concept at least, is here to stay. However, the details of what that means and the new obligations that pharmaceutical companies will need to deal with are yet to be determined. For pharmaceutical compliance professionals, 2018 will continue to be a time of high uncertainty and an ever-increasing workload. This article examines the current state and what the future may hold.


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    November

    2017

    Coming Soon to a State or Even City Near You – Part 2 Spend Disclosure & Much More

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    Nicodemo (Nico) Fiorentino, Esq., Manager, Research & Compliance, for G&M Health LLC

    In 2017, the pharmaceutical industry has been hit hard by the increasing number jurisdictions proposing, passing, and implementing numerous compliance requirements ranging from annually reporting payments and other transfers of a value provided to health care professionals, listing or licensing sales representatives and other employees, being prohibited from offering certain discounts, and facing “gift” limitations and restrictions. These jurisdictions include the City of Chicago (representative licensure and disclosure), Nevada (representative listing and disclosure), California (discount prohibition), Maine (“gift” limitations and restrictions), and New Jersey (proposed regulation to limit and cap meals and restrict consulting agreements). With another major election year ahead of the industry, the pharmaceutical industry will be an easy target. In fact, states will use the success of the previous year, combined with the pricing debate and the opioid crisis, to push through legislation and regulations.


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    November

    2017

    Transparency Perhaps a Falling Star in the U.S. But Rising Internationally

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    Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update

    While interest in transparency seems to be waning in the U.S., it continues to rise internationally with Canada and South Korea. This article will examine the latest numbers from U.S. Open Payments and the efforts of Canada and South Korea.


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    October

    2017

    Coming Soon to a State or Even City Near You – Part 1 Pricing Transparency

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    Nicodemo (Nico) Fiorentino, Esq., Manager, Research & Compliance, for G&M Health LLC

    As opposition to and concern about the activities of drug manufacturers continue to mount, increasingly states, and even cities, are stepping in to regulate pharmaceutical companies. This is the first in a two-part series focusing on the notable proposed state and city actions and laws and ordinances that have been or soon will be enacted in 2017. The article will focus on drug pricing transparency disclosure legislation that is being introduced at an ever-increasing rate. The pharmaceutical industry cannot fight each and every state and city action successfully. The truth of the matter is that the industry is losing ground and leadership within companies cannot begin to sacrifice their compliance and legal departments.


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    July

    2017

    The California Hurdle – SB 790 and Pharma

    Written by , Posted in Transparency

    Jenny McVey, Life Sciences Manager, FRA

    Seven states and the District of Columbia currently have regulations that limit or ban industry gifts to physicians, and it seems as though others are following suit. The California state Senate passed SB 790 in May 2017, a bill restricting pharmaceutical companies from giving gifts and incentives to medical professionals. This article reviews the changes SB 790 calls for, and what compliance professionals should keep an eye on.


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    June

    2017

    Chicago’s Attempt to Regulate Drug Reps – A Real Public Health Initiative or Simple Revenue Generator?

    Written by , Posted in Transparency

    Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update

    Lately pharmaceutical marketing has been under increasing attack at both state and federal governmental levels. Now Chicago has joined D.C. in the attempt to regulate pharmaceutical representatives. Billed by Chicago Mayor Rahm Emanuel as a measure to curb opioid addiction, the actual purpose seems less clear. What is clear is that the ordinance will induce additional costs and complexities for pharmaceutical compliance officers charged with overseeing sales activities.


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    September

    2016

    September

    2016

    State of the European Union – Transparency in Europe 2016 and Beyond

    Written by , Posted in Transparency

    Geert van Gansewinkel, Partner and Managing Director, Polaris Europe

    Three years ago, EFPIA adopted the EFPIA transparency code. Now three years later, this article takes the opportunity to look at what has happened so far with transparency reporting in Europe and what the future may hold.


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    September

    2016

    Pharma & Medtech – Like Chalk & Cheese?

    Written by , Posted in Transparency

    Nick Merryfield and Andrew Wiles of WorldDataOnline LLC.

    The pharmaceutical and medical technology industries appear to show marked transfer of value variations in this year’s Open Payments data. This study investigates further and asks, is it a case of two sectors using unique commercial models, or a simple case of different reporting methodologies?


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    August

    2016

    Transparency Across the Pond – A Look at Efforts in Germany and the UK

    Written by , Posted in Transparency

    Kaitlin Fallon Wildoner, Esq., Staff Writer for Life Science Compliance Update

    On June 30, 2016, transparency efforts around the world released numbers on financial interactions between industry and physicians. This article goes through recent releases in Germany and the United Kingdom, including analysis on where the money is coming from, and who it is going to.


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    August

    2016

    Caveat User, Caveat Emptor – Issues from the Soft Under Belly of The CMS Data Sets

    Written by , Posted in Transparency

    Mark Labovitz, Ph.D., MS, MBA, Principal, Attest Open-Payments™ and President, Data Analysis Consulting (DAC), LLC.

    While the goal of Open Payments and transparency are arguably good public policy, the usefulness of Open Payments depends entirely on the quality of the underlying data. This paper explores some of challenges found in the 2015 data set that negatively impact that usefulness.


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