Life Science Compliance Update

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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  • 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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    November

    2017

    The Expanding Frontier Part 3 – PAGs in Light of the Aegerion Cases

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

    There is no doubt that Patient Advocacy Groups play an important and substantial role in shaping the healthcare landscape. It also is true that it is not a simple matter for life sciences companies to work with these groups. This article examines the recent trio of cases involving Aegerion to ascertain what it says about the government’s enforcement stance and how that it may shape the future of industry/PAG interactions.


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