Life Science Compliance Update

May

2018

Not Your Average OIG Presentation – Greg Demske Defines A “Successful” OIG Based On Fairness, Communication, And Compliance At The Mitchell Hamline Symposium

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Gwendolyn Ball, Staff Writer, Life Science Compliance Update

Recently Greg Demske, Chief Counsel for the Department of Health and Human Services Office of Inspector General provided the keynote address at Mitchell Hamline’s Health Law Institute Symposium, “Hot Topics in Healthcare Compliance.” His speech was noteworthy not because he announced new policies, but rather for its focus and key messages of fairness, communication and compliance.


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January

2018

Like the Little Drummer Boy, the Beat Goes on as OIG Enforcement Shows Few Signs of Letting Up

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Kristen Schwendinger, Senior Managing Consultant, Berkley Research Group

As life science compliance professionals know, it is important to monitor what the HHS OIG focuses on. This article reviews the OIG’s focus in 2017 and looks ahead to what may be in store for 2018.


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December

2017

Even Distributors Are Not Immune – AmeriSourceBergen’s Recent Compliance Struggles

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Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update

In recent months, AmeriSourceBergen’s (“ABC”) ongoing struggles with compliance about its corporate subsidiaries and wholesale units has been well-publicized. For instance, on August 23, 2017, the United States Department of Justice (“DOJ”) announced a settlement $13.4 Million involving illicit False Claims Act (“FCA”) and kickback billing activities by U.S. Bioservices Corp., a unit of wholesale ABC concerning the medication Exjade. In a separate matter, the DOJ a settlement with ABC to resolve criminal liability relating to illicit business activities by AmeriSouceBergen Specialty Group (“ABSG”), a subsidiary of ABC involving the misbranding and distribution of oncology cancer related medications from a processing facility that was not approved by the U.S. Federal Food and Drug Administration (“FDA”). Both cases highlight the FCA civil, and criminal liability parent companies face for the illicit conduct of their various corporate subsidiaries and entities.


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December

2017

Mylan’s “Banquet of Consequences” Ends for Now with the Latest EpiPen Settlement

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

Mylan has been the subject of bad press for roughly a year now. Fortunately, it seems as though the firestorm surrounding the company – including the EpiPen price saga – may be over for now. This article outlines a recent suit filed by a Mylan competitor and the settlement and CIA that resulted. It concludes with insight from a prominent CEO about how compliance officers and other executives can avoid the negative press Mylan has endured.


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