Life Science Compliance Update

August

2017

August 2017: Life Science Compliance Update

Written by , Posted in August 2017 LSC Update, Home page, This Month in Compliance

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August 2017 LSCU Cover

Issue Summary

Welcome to the Dog Days of Summer! This month we focus once more on off-label promotion, with a special three-part series. We also take a look at recent developments involving the Escobar case and the latest from the U.S. Supreme Court on products liability/mass tort jurisdiction. Finally, we have an article from Matt Kelly on the Fine Art of Policy Management.


LSCU Special Feature

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A Murky Future for Off-label Promotion

Within the world of life science product regulation, the area of off-label promotion is perhaps the most complicated, emotional and uncertain of all. It is an ever-changing landscape of regulations, court decisions and now politics. It is a landscape that the LSCU has covered in many issues, and once more it is making headlines. This three-part series will explore the impact that the new FDA Commissioner will have on the debate, how Congressional efforts could make things even more complicated for life science compliance professionals, and the latest efforts by Arizona to allow off-label promotion. – Dr. Seth Whitelaw, Editor

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PART 1: New Leadership at the FDA Brings Change
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
Abstract

On May 11, 2017, Dr. Scott Gottlieb was sworn in as the U.S. Food and Drug Administration’s latest Commissioner. Since that time, there has already been various regulatory changes and shifts, in terms of policy guidance, as well as a new focus toward easing the Agency’s rules and regulations pertaining to off-label uses. The article will explore those changes and the Agency continues to refine the “intended use” rules.

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PART 2: Off-Label Bills Garner Minimal Traction in Congress
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
Abstract

Further muddying the off-label waters is the fact that Congress has introduced several bills, attempting to legislate off-label use. Both bills were initially introduced as attachments to the FDA reauthorization bill, but when House Democrats resisted, both sponsors pulled the bills as attachments. On July 12, 2017, the Subcommittee on Health held a brief hearing on both bills, giving industry and others a chance to speak on off-label promotion.

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PART 3: States vs. FDA – Arizona to Allow Pharma Companies to Legally Communicate Off-Label Treatment Options
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
Abstract

Arizona was the first state to bite the bullet and allow pharmaceutical companies to communicate off-label uses of their drugs to physicians and other healthcare professionals. This article not only discusses the Arizona bill but also outlines some factors that may help us to understand where the landscape is heading on this issue.

False Claims

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A New Application of Escobar: Gilead or When Half-Truths Can Become Actionable Under the FCA
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
Abstract

On July 7, 2017, the Ninth Circuit in a very closely watched opinion determined that the whistleblowers in this case had demonstrated viable claims under the False Claims Act (“FCA”), alleging that their employer, Gilead Sciences, Inc. (“Gilead”) had made false statements to the U.S. Food and Drug Administration (“FDA”) regarding its HIV drug, resulting in billions of dollars of illicit payments from the government to Gilead. Such judicial decision is highly significant in that it is the first substantive Circuit Court decision since the U.S. Supreme Court decision in Universal Health Care v. Escobar, which effectively raised the legal burden by whistleblowers to demonstrate claims under the FCA.

Compliance Operations

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Independent Review Organizations (“IRO”) and Conflicts of Interest – Much Ado About Nothing or a Serious Problem
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
Abstract

As part of the process of entering into civil and criminal settlement negotiations with the government resulting from allegations of noncompliance, life science companies are increasingly seeking the retention of third-party regulatory compliance and auditing companies, designated collectively as independent review organizations (“IROs”) to facilitate such process. Recently, there is renewed skepticism and heightened criticism over the companies’ use of such IROs, especially given revelations that companies are choosing IROs that they may have had business relationships with in the past or present. Despite this, the U.S. Department of Justice (“DOJ”) and other government oversight agencies argue that the current status quo is effectively working, including the already established standards, qualifications, and other guidelines for the selection of an IRO. This article examines the various view points and what it means for the life science compliance professional.

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The Fine Art of Policy Management
Matt Kelly, Editor & CEO at Radical Compliance
Abstract

Management of corporate policies is a primary challenge for compliance officers in today’s life sciences sector. Recent guidance from the Justice Department and OIG-HHS about effective compliance programs does elaborate on what a strong policy management program should do. In this article, we examine five basic abilities that all policy management programs should have—things that your program must be able to do, regardless of your organization’s specific structure and processes, if you want an effective program that can endure in today’s highly regulated environment.

Tort Reform

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This Isn’t Walmart: The Supreme Court Narrows Forum-Shopping Options
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
Abstract

In a decision of great import to pharmaceutical and device companies, the Supreme Court ruled in favor of Bristol-Myers Squibb in a jurisdictional argument at the nation’s Highest Court. This article outlines the background, the case decision, and the decision’s ramifications to companies.

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