Life Science Compliance Update

April

2018

The War on Patient Assistance Programs Takes a New Twist – The Tortured History of Caring Voice Coalition

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

In the most recent chapter in the ongoing battle over the priority of patient assistance programs, the Caring Voice Coalition recently announced it would not provide financial assistance for any diseases in 2018. As a result of this announcement, HHS OIG is turning to PhRMA for help.


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February

2018

Staring Down Another First Amendment Challenge – The OIG vs. Patient Services

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

Patient Assistance Programs (“PAPs”) are starting to feel the heat from various United States agencies, as we have noted in several issues over the past year. Recently, Patient Services, Inc., filed suit in response to a Modified Advisory Opinion issued by the HHS OIG. This article outlines the changes and the suit.


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February

2018

When Good Intentions Go Astray – United Therapeutics Settles AKS Suit

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

With the United Therapeutics settlement, it is clear that the DOJ remains focused on patient assistance programs and other similar charities. As a result, additional settlements involving these programs are likely to continue in 2018, once more pitting established legal constructs against current fiscal realities.


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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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November

2017

The Expanding Frontier Part 2 – Navigating the Complexity of Patient Advocacy Groups

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Chad A. Morin, Senior Director Healthcare Compliance, bluebird bio

Although many Patient Advocacy Groups have been around for more than 20 years, it has only been in the past couple years that they have had a substantial impact. It is clear that engaging with and assisting PAGs can provide a shared-value to patients. However, doing so is not a simple matter, and this article explores some of the many factors that companies should consider.


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June

2017

The Battle Over Patient Assistance Programs Heats Up

Written by , Posted in Enforcement

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

Patient assistance programs have been in the spotlight for the past few years as the drug pricing controversy comes to a head. This article outlines some of the recent subpoenas, with a focus on the most recent subpoena to make the news, that of Pfizer.


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February

2017

Avoiding the Patient Assistance Program Spotlight

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Kristin Rand, JD, MS, Compliance Officer, Seattle Genetics

In efforts to understand the rising cost of some drugs Patient Assistance programs, particularly independent foundations, have become a focus of government investigations. This article explains what PAPs are, why they may be viewed as suspect and provides tips for providing patient assistance in a compliant manner.


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