Life Science Compliance Update

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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November

2017

Increasing the Tension – Expanding Patient Access to Investigational Medical Products

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Maureen Lloyd a Health Industries, Risk and Regulatory Director and Dixil Francis a Health Industries, Risk and Regulatory Manager at PWC

Expanding patient access to therapies currently being tested but not yet marketed is both increasingly challenging and important. However, despite the many challenges, changing regulations and industry association guidelines have increased pressure on manufacturers to develop or expand their access to medicines programs. Therefore, it is clear that improving appropriate patient access to investigational medical products remains a prominent objective for the life science industry. This article explores the changing environment surrounding expanded patient access and the practical implications facing life science companies trying to balance competing concerns.


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