Life Science Compliance Update

June

2017

June 2017: Life Science Compliance Update

Written by , Posted in June 2017 LSC Update, This Month in Compliance

The full text of this issue is available to our subscribers. If you are a subscriber please log in now. If you are not a subscriber, and would like to become one, please click on the subscribe link or read about all of the benefits a subscription brings by clicking on the Subscribe menu item above.

June 2017 LSCU Cover

Issue Summary

This month we focus on the very real compliance issue of connecting with patients. First, Nico Fiorentino explores the history and latest case involving the use of clinical educators. Then we take another look at the issue of patient assistance programs and the most recent batch of subpoenas. Next Jenny McVey and Mark Scallon explore the General Data Protection Regulation which is set to have substantial impact on the life sciences industry. Finally, we look at the latest developments in transparency, false claims act cases and the 21st Century Cures Act.


Feature

Arrow

White Coat” Marketing Gone Awry
Nicodemo (Nico) Fiorentino, Esq., Manager, Research & Compliance, for G&M Health LLC
Abstract

Achieving patient adherence to prescribed medication through clinical educator programs is not a new concept. Neither is the U.S. Office of Inspector General of the Health and Human Services longstanding concern of the inherent issues these programs pose when offered and provided by the pharmaceutical industry. A recently unsealed False Claims Act whistleblowers’ complaint provides an example of the delicate balance companies face in ensuring compliance with federal and state laws, regulations, sub-regulatory guidance, and industry codes. Expect additional cases in the future, especially if you think your “compliant” educator program is a pandora’s box.

Enforcement

Arrow

The Battle Over Patient Assistance Programs Heats Up
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
Abstract

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.

Privacy

Arrow

Europe Moves to the Next Level in Protecting Personal Data – The GDPR & Research
Jenny McVey, Life Sciences Manager, Mark Scallon, Life Sciences Partner, FRA
Abstract

As cross-border business and technology advances, the European Union’s need to address data privacy protection continually rises. The General Data Protection Regulation will soon be enforceable and undoubtedly will have impact on how pharmaceutical and medical device companies conduct clinical trials and research studies. This article reviews key updates for companies to consider for their clinical trials and research functions as the May 25, 2018 enforcement date approaches.

Transparency

Arrow

Chicago’s Attempt to Regulate Drug Reps – A Real Public Health Initiative or Simple Revenue Generator?
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance UpdateTM by NXLevel Solutions
Abstract

Lately pharmaceutical marketing has been under increasing attack at both state and federal governmental levels. Now Chicago has joined D.C. in the attempt to regulate pharmaceutical representatives. Billed by Chicago Mayor Rahm Emanuel as a measure to curb opioid addiction, the actual purpose seems less clear. What is clear is that the ordinance will induce additional costs and complexities for pharmaceutical compliance officers charged with overseeing sales activities.

False Claims

Arrow

Genentech & Escobar: Using Materiality to Escape False Claims Liability
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
Abstract

In constructively bringing an end to a False Claims Act (“FCA”) whistleblower suit alleging Genentech, Inc.(“Genentech”) of defrauding Medicare by way of concealing substantive health care analytics data involving purported side effects of the company’s cancer drug Avastin the Third Circuit of Appeals in a recent decision determined that the Plaintiff in this matter had failed to demonstrate that any noncompliance had an impact on government payments. Specifically, the Court applied the prevailing standard in Escobar that an FCA lawsuit must demonstrate that any misrepresentation is “material” to the government’s payment decision. In dismissing this suit and invoking this heightened standard of materiality, the Third Circuit not only reinforces Escobar but places the now clear burden on FCA Plaintiffs to demonstrate that any noncompliance was material to alleged fraudulent payments.

Arrow

An FCA Journey – Allergan to Pay $53M to DOJ
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
Abstract

Allergan has been hit with hefty fines over the past several months. This article outlines the recent DOJ settlement, Allergan’s alleged wrongdoing, and the settlement amount agreed to by the government and Allergan.

Legislation

Arrow

The 21st Century Cures Act: Is It Worth the Cost for Lifesciences?
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
Abstract

The 21st Century Cures Act (“Act”), which provides substantial funding for medical research, seeks to alleviate the regulatory process for developmental and experimental treatments and to implement reform measures on mental health care. This article explores whether the long-term the Act’s benefits will outweigh the costs.

Menu Title