Life Science Compliance Update
Life Science Compliance Update is a monthly publication providing comprehensive, up-to-date compliance information for pharmaceutical, biotechnology, and device manufacturers. Each issue covers important news and analysis, with input from top compliance officers and healthcare attorneys across the industry.

September

2017

September 2017: Life Science Compliance Update

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

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July 2017 LSCU Cover

Issue Summary

This month we feature an extensive, in-depth look into the drug distribution verification law in Ohio, which will significantly impact product sampling in the state. We also take a look a mid-year look at False Claims Act settlement and the recent data from U.S. DOJ’s FCPA Pilot Program. Rounding out the issue are a look at two recent FCA cases involving Fresenius and Celgene, both of which have the promise to impact how FCA cases are pursued in the future.


Feature

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Ohio Drug Distribution Verification: America’s Key Battleground State Shakes Up the Pharmaceutical Supply Chain
Nicodemo (Nico) Fiorentino, Esq., Manager, Research & Compliance, for G&M Health LLC; John Patrick Oroho, Esq., Executive Vice President and Chief Strategy Officer, Porzio Life Sciences, LLC, Principal, Porzio, Bromberg & Newman PC; Teresita Weiss, Ph.D., J.D., Sr. Vice President, Regulatory Affairs and Compliance, for J. Knipper and Company, Inc.; Bryan Andrews, Director of Sales Operations, MedPro Systems LLC.
Abstract

The pharmaceutical industry faces monumental challenges in the age of globalization within the United States: state laws and regulations that are more stringent than their federal counterparts. This article provides the historical context and current overview of Ohio’s laws, regulations, and sub-regulatory guidance concerning the distribution of prescription drugs, including drug samples, into and within the state, the verification requirements when distributing product to terminal distributors of dangerous drugs and prescribers, record retention responsibilities, and penalties for noncompliance. The article then examines the industry’s response from a major manufacturer, a distributor/third-party logistics provider, verification vendor, and compliance advisory vendors. It concludes with a call to action to the industry to form a new coalition to address state legislative and regulatory actions that have the potential to disrupt the entire supply chain.

False Claims & Enforcement

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False Claims Act Mid-Year Review: Significant Life Science Settlements, Post-Escobar Developments & Industry Round Up
John Kelly, Julia Tamulis, and Robert Platt
Abstract

Several significant False Claims Act settlements and judgments in the first six months of 2017 suggest this year will result in the eighth year of over $3 billion in FCA recoveries. Additionally, recent judicial decisions in FCA suits have further refined the test outlined in the Supreme Court’s 2016 Escobar decision, statistical sampling has resulted in significant FCA liability.

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To Disclose or Not to Disclose…. That is the Question: The DOJ’s FCPA Pilot Program – Insights from Year One and Beyond
Mark Scallon, Partner, FRA Life Sciences, Jenny McVey, Manager, FRA Life Sciences and Jimmy Ko, Senior Associate, Forensic Risk Alliance
Abstract

It has been over one-year since the US Department of Justice has launched its pilot program aimed to incentivize companies to self-report potential Foreign Corrupt Practices Act violations. Since its launch on April 5, 2016, the Justice Department resolved nine investigations. However, the question still remains – “Is the carrot bigger than the stick?” This article examines settlement trends before and during the Pilot Program to answer the question of whether or not it is sensible to self-disclose.

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Fresenius to the U.S. Government: When It Comes to the FCA, You Snooze You Lose
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
Abstract

In a nearly decade long lawsuit allegations that the company violated the False Claims Act by conducting and then billing the government for medically unnecessary hepatitis B tests, Fresenius is now seeking to challenge that the government is time-barred because the government took too long to intervene in this case. Although the Court has yet to decide the challenge by Fresenius, the outcome of that decision will likely have a significant impact on future government decisions to intervene in False Claim Act cases.

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Taking Center Stage – Washington State’s Medicaid Fraud Control Unit, the False Claims Act and Celegene
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
Abstract

On July 26, 2017, the Washington State Attorney General Bob Ferguson announced one of the State’s largest recoveries against the pharmaceutical company Celgene for allegations involving violations of the Medicaid False Claims Act, in particular claims related to the company’s off-label marketing, fraudulent billing and providing kickbacks to doctors. The Washington State AG recovery represents a pivotal point in life science compliance, where State AGs, are actively seeking recoveries against companies that violate state and federal Medicare programs.

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