Life Science Compliance Update

June

2018

Where In The World Is OPDP? Where In The World Is OPDP?

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Kaitlin Fallon Wildoner, Esq. and Seth B. Whitelaw, J.D., LL.M, S.J.D.

OPDP enforcement activities have sharply declined over the past several years. That trend continues in 2018 as OPDP has only issued one letter involving opioids and a conference booth. This article looks at the trend, reviews the most recent letter and tries to determine what this means for compliance and regulatory professionals.


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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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