Life Science Compliance Update

February

2018

February 2018: Life Science Compliance Update

Written by , Posted in February 2018 LSC Update, Home page, This Month in Compliance

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February 2018 Issue Free Article

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One Purpose to Rule Them All – A Resounding “Yes” According to the District Court in U.S. Ex Rel. Cairns
By Robert N. Wilkey, Esq., Staff Writer and Seth B. Whitelaw, J.D., LL.M., S.J.D., Editor for Life Science Compliance Update
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The breadth of liability under the False Claims Act and Anti-Kickback Statute is a closely watched area. Recently, the U.S District Court for the Eastern District of Missouri concluded that liability might extend to a health care provider even where the plaintiff fails to demonstrate that the “primary purpose” of providing the benefits was to create an inducement. Although the impact of such Court case remains somewhat uncertain, it is expected that the Court’s ruling will continue to expand FCA and AKS liability.

February 2018 Issue Summary

February 2018 LSCU Cover

This month’s issue is focused on three main areas: drug pricing, patient assistance programs and the False Claims Act. As our feature article, Nicodemo Florentino explores the often-overlooked antitrust areas of “shadow pricing” and “conscious parallelism.” Next, we look at the recent settlement by United Therapeutics and its potential impact on patient assistance program charities and how the OIG’s efforts to regulate this area may lead to the next big 1st Amendment battleground.

We then turn our attention recent False Claims Act developments including the one purpose test and the DOJ’s apparent shifting view of qui tam actions.


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Casting Some Light on Shadow Pricing
Nicodemo Fiorentino, Esq.
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Prescription drug prices continue to rise and focus attention on the pharmaceutical industry. Currently the industry faces hearings at the federal level, new legislation at the state level and almost daily media coverage due to this issue. The Sherman Antitrust Act, passed in 1890, is also being used against the industry. Often overlooked, “shadow pricing” and “conscious parallelism” are two ways in which manufacturers allegedly can restrain trade and competition. This article is aimed at helping compliance and legal professionals become familiar with antitrust and how it presents a present and future compliance risk. The article further represents a call for compliance and legal professionals to be involved with how their company sets pricing.

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When Good Intentions Go Astray – United Therapeutics Settles AKS Suit
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
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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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Staring Down Another First Amendment Challenge – The OIG vs. Patient Services
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
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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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One Purpose to Rule Them All – A Resounding “Yes” According to the District Court in U.S. EX Rel. Cairns
Robert N. Wilkey, Esq., Staff Writer and Seth B. Whitelaw, J.D., LL.M., S.J.D., Editor for Life Science Compliance Update
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The breadth of liability under the False Claims Act and Anti-Kickback Statute is a closely watched area. Recently, the U.S District Court for the Eastern District of Missouri concluded that liability might extend to a health care provider even where the plaintiff fails to demonstrate that the “primary purpose” of providing the benefits was to create an inducement. Although the impact of such Court case remains somewhat uncertain, it is expected that the Court’s ruling will continue to expand FCA and AKS liability.

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Revisiting the Past – Warner Chilcott vs. Insys
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
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Those who remember the Warner Chilcott and W. Carl Reichel case from just two years ago may have had déjà vu when they heard about the recent legal controversy surrounding John N. Kapoor and Insys. This article reviews the current Insys and Kapoor developments and compares the two cases to analyze whether the trend of involving high-ranking executives is the future of enforcement.

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Has the Shine Worn Off False Claims QUI TAM Actions
Gwendolyn Ball, Staff Writer, Life Science Compliance Update
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At the recent HCCA Annual Conference, the Deputy Director of DOJ’s Civil Fraud Section may have signaled a change in policy relative to handling qui tam cases. This article explores the issue and what it might mean for life science companies going forward.

January

2018

January 2018: Life Science Compliance Update

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The Monster in the Closet – New WHO Report Shines a Light on the Problem of Substandard & Falsified Medicines
By Gwendolyn Ball, Staff Writer, Life Science Compliance Update
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The issue of substandard and counterfeit medicines has been known for some time. Since it is not often discussed openly, it is difficult to get an appreciation for the scope of the problem. However, a new WHO report, backed by four years’ worth of data, sheds some light on the matter and gives some guidance on how to identify likely problems and respond to them.

January 2018 Issue Summary

January 2018 LSCU Cover
Happy New Year everyone! As we start off 2018, we thought it was appropriate to think about New Year’s Resolutions, and so our feature article this month discusses the need to assess the company culture and possible ways to do it. Then in the spirit of holiday giving, we examine the 2017 OIG enforcement data to see what that bodes for 2018 and we see what the DOJ brought us in the form of a permanent FCPA Pilot Program. Finally, in keeping with the fact that life sciences is a global industry, we examine the new GPDR requirements in the EU, which are set to take effect in May 2018, as well as the unsettling WHO report on substandard and falsified medicines.

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A Compliance New Year’s Resolution – Assess the Company’s Culture
Jenny McVey, Associate Director and Frances McLeod, Founding Partner, FRA
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The topic of ‘company culture’ is certainly not new, but it continually emerges as a hot topic within regulatory circles. An organization’s culture is recognized to exert a powerful influence on how a company and its people conduct business. Although there is an inherent understanding that by continually enhancing company culture, ethical aspects of the organization will follow suit, why isn’t culture reviewed with the same rigor and principles that are required for compliance programs? This article will discuss the importance to evaluate an organization’s culture of compliance, and will introduce some considerations on how this can be done.

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Like the Little Drummer Boy, the Beat Goes on as OIG Enforcement Shows Few Signs of Letting Up
Kristen Schwendinger, Senior Managing Consultant, Berkley Research Group
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As life science compliance professionals know, it is important to monitor what the HHS OIG focuses on. This article reviews the OIG’s focus in 2017 and looks ahead to what may be in store for 2018.

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Christmas Comes Early – The FCPA Pilot Program Made Permanent
Jenny McVey, Associate Director, Forensic Risk Alliance
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When we first introduced the FCPA Pilot Program in the June 2016 issue, we noted the uncertainties of outcomes for companies who voluntarily self-disclose potential violations. On November 29, 2017, Deputy Attorney General Rod Rosenstein announced that the US Department of Justice (DOJ) had made the FCPA Pilot Program permanent. This article will review some of the key highlights outlined by the DOJ and some considerations for compliance professionals.

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Privacy Upheaval – Exploring the Impact of the GDPR on Companies Sponsoring and Managing Global Clinical Research
By Michelle Wilcox DeBarge, Partner, Wiggin and Dana LLP
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In May 2018, the new European Union (“EU”) General Data Protection Regulation (“GDPR”) will replace the familiar Data Protection Directive. In addition to significant new penalties, the GDPR requires companies to examine and rethink their data strategies, especially when working with clinical trials. This article discusses key considerations in implementing the GDPR for companies sponsoring and managing clinical trials.

December

2017

December 2017: Life Science Compliance Update

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

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December 2017 LSCU Cover

Issue Summary

For much of 2017, we have focused on ENFORCEMENT issues. While the December issue no exception, we also are focusing on topics that impact COMPLIANCE OPERATIONS. Therefore, we are featuring an article by Sean Murphy and Lauren Barnett of PharmaCertify on enhancing COMPLIANCE LEARNING to maximize RETENTION. We also examine the challenges faced by Novartis’ GLOBAL COMPLIANCE FUNCTION and the dangers of EXAGGERATING BILLING CODES.
In the case of new developments impacting compliance operations, we take a look at FDA’s work plan to implement the 21st CENTURY CURES ACT, as well as Allergan’s attempted use of NATIVE AMERICAN SOVEREIGNITY to protect its PATENT position.
Of course, no issue would be complete, without the ENFORCEMENT roundup. This month we look at MYLAN’s recent EPIPEN settlement, AMERISOURCE BERGEN’S continuing FALSE CLAIMS and FDA compliance woes.


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Learning After You Know It All – Enhancing Compliance Learning and Maximizing Retention
Sean Murphy and Lauren Barnett of PharmaCertify™ by NXLevel Solutions

Research shows that as much as 80% of the information learned in an instructor-led event, or eLearning course is rapidly forgotten. Even after the information is transferred to a learner’s working memory, storage of that information decays if it is not recalled and re-encoded. When the key concepts, policies, and best-practices presented in life sciences compliance training are forgotten soon after training events are completed, the organizational risk rises dramatically, and compliance cultures are weakened. By contrast, a continuous learning approach to compliance training incorporates four evidence-based strategies (review and reinforcement, gamification, microlearning, and assessments) into the delivery of learning components. When training is deployed strategically and continuously across a leaner’s timeline, engagement levels rise, retention is maximized, and global risk is reduced.

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The Ongoing Struggles of Novartis’ Global Compliance Function
Robert N. Wilkey, Esq., Staff Writer and Seth Whitelaw, J.D., LL.M., S.J.D., Editor for Life Science Compliance Update

In recent months, the pharmaceutical company Novartis, has been hit with some high profile international corruption scandals in South Korea and Greece. Although such large-scale scandals involving pharmaceutical and medical device companies is nothing new, the Novartis case study brings to light the challenges of providing effective compliance for life science companies actively engaged in market expansion abroad. In this article, we will briefly examine how Novartis is working to address those challenges. However, in the end, meeting that challenge is going to take cultural savvy, flexibility and above all stamina.

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When Exaggeration Increases Compliance Risk – The Lessons of UHC and Inflated Risk Scores
Janice G. Jacobs, CPA, CPC, CCS, CPCO, ROCC, Managing Director, Berkeley Research Group

Fraudulently exaggerating diagnosis coding is definitely on the government’s radar. This article explores the compliance risks associated with exaggerating diagnosis codes and ways to mitigate potential liability.

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The 21st Century Cures Act Moves One Step Closer to Reality with FDA’s Work Plan
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update

With the formal legislative passage of the 21st Century Cures Act (“Act”), a bipartisan effort to expedite research and development and approval of new drugs, the U.S. Food and Drug Administration (“FDA”) is now moving full-steam ahead by making public its legislative implementation work plan in regard to the Act, including a list of agency policy objectives, list of deliverables, and a detailed summary of budget allocations for such Act. Although the FDA’s implementation efforts in this regard are still emerging, it is clear that the Agency is seeking in every way possible to make the Act a new reality for all stakeholders in the life sciences community.

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The New Westward Expansion – Big Pharma Partners with Native Americans to Protect Patents
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update

As each pharmaceutical asset becomes more expensive to bring to market, patent protection and patent extension are critical to a drug company’s sustainability. Now, it seems that one drug maker (Allergan PLC) may have found a way to capitalize on the often-forgotten fact of Native American tribal sovereignty to thwart off intellectual property challenges and create additional barriers to market entry. Regardless of whether the strategy is successful, it will bring renewed interest in finding ways to work with tribal interests and one more legal area that compliance officers may need to have a working knowledge about.

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Mylan’s “Banquet of Consequences” Ends for Now with the Latest EpiPen Settlement
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update

Mylan has been the subject of bad press for roughly a year now. Fortunately, it seems as though the firestorm surrounding the company – including the EpiPen price saga – may be over for now. This article outlines a recent suit filed by a Mylan competitor and the settlement and CIA that resulted. It concludes with insight from a prominent CEO about how compliance officers and other executives can avoid the negative press Mylan has endured.

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Even Distributors Are Not Immune – AmeriSourceBergen’s Recent Compliance Struggles
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update

In recent months, AmeriSourceBergen’s (“ABC”) ongoing struggles with compliance about its corporate subsidiaries and wholesale units has been well-publicized. For instance, on August 23, 2017, the United States Department of Justice (“DOJ”) announced a settlement $13.4 Million involving illicit False Claims Act (“FCA”) and kickback billing activities by U.S. Bioservices Corp., a unit of wholesale ABC concerning the medication Exjade. In a separate matter, the DOJ a settlement with ABC to resolve criminal liability relating to illicit business activities by AmeriSouceBergen Specialty Group (“ABSG”), a subsidiary of ABC involving the misbranding and distribution of oncology cancer related medications from a processing facility that was not approved by the U.S. Federal Food and Drug Administration (“FDA”). Both cases highlight the FCA civil, and criminal liability parent companies face for the illicit conduct of their various corporate subsidiaries and entities.

November

2017

November 2017: Life Science Compliance Update

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

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November 2017 LSCU Cover

Issue Summary

This month, Life Science Compliance Update has a SPECIAL ISSUE devoted to FOCUS ON THE PATIENT. To open the issue, we explore the critical issue of ACCESS TO MEDICINE and the growing impact of CORRUPTION and what the pharmaceutical industry can do to the help. Continuing the theme of access, we examine the changing environment around EXPANDED PATIENT ACCESS to INVESTIGATIONAL MEDICINES and the balancing act this causes for life science companies.

Next, we continue our series EXPANDING THE FRONTIER examining how companies should consider working with PATIENT ADVOCACY GROUPS and the impact of the latest ENFORCEMENT decisions in the AEGERION cases. Finally, we round out this issue with a look at the latest TRANSPARENCY developments including new OPEN PAYMENTS data, new initiatives in SOUTH KOREA and CANADA, and finally the latest STATE and LOCAL government efforts to expand transparency requirements.


Special Issue: Focus on the Patient

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Why it matters – Pharmaceutical compliance, Anti-corruption and Access to Medicine
Luca Genovese and Danny Edwards, The Access to Medicine Foundation

Access to medicine continues to be out of reach for an estimated two billion people worldwide. While it is clear that corruption plays a role in that problem, the true scope and cost of global health corruption is unknown. This article examines what pharmaceutical companies do and what role they should play in eliminating corruption as part of the equation of ensuring access.

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Increasing the Tension – Expanding Patient Access to Investigational Medical Products
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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The Expanding Frontier Part 2 – Navigating the Complexity of Patient Advocacy Groups
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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The Expanding Frontier Part 3 – PAGs in Light of the Aegerion Cases
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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Transparency Perhaps a Falling Star in the U.S. But Rising Internationally
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update

While interest in transparency seems to be waning in the U.S., it continues to rise internationally with Canada and South Korea. This article will examine the latest numbers from U.S. Open Payments and the efforts of Canada and South Korea.


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Coming Soon to a State or Even City Near You – Part 2 Spend Disclosure & Much More
Nicodemo (Nico) Fiorentino, Esq., Manager, Research & Compliance, for G&M Health LLC

In 2017, the pharmaceutical industry has been hit hard by the increasing number jurisdictions proposing, passing, and implementing numerous compliance requirements ranging from annually reporting payments and other transfers of a value provided to health care professionals, listing or licensing sales representatives and other employees, being prohibited from offering certain discounts, and facing “gift” limitations and restrictions. These jurisdictions include the City of Chicago (representative licensure and disclosure), Nevada (representative listing and disclosure), California (discount prohibition), Maine (“gift” limitations and restrictions), and New Jersey (proposed regulation to limit and cap meals and restrict consulting agreements). With another major election year ahead of the industry, the pharmaceutical industry will be an easy target. In fact, states will use the success of the previous year, combined with the pricing debate and the opioid crisis, to push through legislation and regulations.

October

2017

October 2017: Life Science Compliance Update

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

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November 2017 LSCU Cover

Issue Summary

Our feature article this month is a review of the FDA’s recent guidance on OFF-LABEL communications. We also begin a two-part series on STATE and LOCAL activities to regulate the pharmaceutical industry starting with a look at PRICING TRANSPARENCY initiatives. Commercial interactions with PATIENTS and PATIENT ADVOCACY groups is next followed by the latest developments with Ohio’sDRUG SAMPLE VERIFICATION rules. We round out the month with the latest on ENFORCEMENT and WHISTLEBLOWERS.


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The Never-Ending Saga of Off-label Promotion
Jenny McVey, Associate Director, FRA Life Sciences

The concern of misbranded products leading to patient harm and potential fraud is inarguable. The FDA has held a long-standing position on off-label communication; however, in light of recent federal lawsuits that have increased the uncertainty of its enforceability, as well as the growing need for data-driven medicine, the agency has been under pressure more than ever to update their regulatory position. This article will outline industry’s response and the long-awaited guidance from the FDA around off-label communication.

Issue Articles

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Coming Soon to a State or Even City Near You – Part 1 Pricing Transparency
Nicodemo (Nico) Fiorentino, Esq., Manager, Research & Compliance, for G&M Health LLC

As opposition to and concern about the activities of drug manufacturers continue to mount, increasingly states, and even cities, are stepping in to regulate pharmaceutical companies. This is the first in a two-part series focusing on the notable proposed state and city actions and laws and ordinances that have been or soon will be enacted in 2017. The article will focus on drug pricing transparency disclosure legislation that is being introduced at an ever-increasing rate. The pharmaceutical industry cannot fight each and every state and city action successfully. The truth of the matter is that the industry is losing ground and leadership within companies cannot begin to sacrifice their compliance and legal departments.

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The Expanding Frontier – Commercial Interactions with Patients and Patient Organizations
David Davidovic, Founder, pathForward; former Global VP, Commercial Services, Genentech and Roche

Over the past two decades, the role that patients play in their health care has dramatically shifted. As a result, there is an increasing need and drive by life science companies to engage with patients (e.g., patient centricity). However, this approach is not without risk as this article will explore.

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UPDATE: Round 2 with Ohio’s Drug Sample Verification Requirements
Nicodemo (Nico) Fiorentino, Esq., Manager, Research & Compliance, for G&M Health LLC, Bryan Andrews, Director of Sales Operations, MedPro Systems LLC

In the September issue of the Life Science Compliance Update, the authors discussed the new Ohio drug distribution verification requirements that impact non-controlled prescription drug sampling. This article provides an update with new information from the Ohio State Board of Pharmacy, as well as a one-page “cheat sheet” of those requirements.

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Getting Serious About Fraud – The DOJ Charges 412
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update

With the new administration, there appears to be a renewed commitment to enforcing anti-kickback rules against healthcare providers committing fraud against the government insurance programs. In July 2017, the Department of Justice and Department of Health and Human Services announced the largest-ever fraud takedown in the health care arena. This article outlines the announcement, and what it may mean for the future of health care.

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Will Your Whistle Be Heard at Home?
Sally Foroughi, Staff Writer, Life Science Compliance Update

The distinct split between the Second and Fifth Circuit Courts’ interpretation as to when whistleblower protections are allowed has now summoned the attention of the U.S. Supreme Court. Despite clarifications issued in 2015 by the SEC to shed more clarity on Dodd Frank’s anti-retaliation protection to whistleblowers who reported alleged misconduct either internally to company officials or externally to government regulatory bodies, the U.S. Supreme Court will take the case of Digital Realty Trust v. Somer in the Fall of 2017, and finally render a final verdict for when whistleblower protection becomes enforceable. During the interim, it becomes vital for Compliance Officers to have appropriate policies and procedures in place to guide employees in reporting potential misconduct and/or fraud, and to establish a tone of non-retaliation for such reporting, in order to safeguard the best interests of the public and shareholders of the company.

September

2017

September 2017: Life Science Compliance Update

Written by , Posted in 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.


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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.
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Issue Articles

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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
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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
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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
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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
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August

2017

August 2017: Life Science Compliance Update

Written by , Posted in August 2017 LSC Update, 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
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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
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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
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Other Issue Articles

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

2017

July 2017: Life Science Compliance Update

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

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July 2017 LSCU Cover

Issue Summary

For the July issue, we have focused compliance program effectiveness. Our feature this month explores compliance resourcing challenges for small to mid-sized pharmaceutical companies. We follow this up with a detailed review of the new DOJ and OIG guidance documents. We also take a hard look at project pricing and how the current legal and regulatory structure may impinge on efforts to reduce costs. Finally, we take a look at the latest developments in transparency and false claims enforcement.


Feature Article

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This is Not Your Parent’s Compliance Program – The New Era of Compliance Resourcing at Small to Mid-Size Pharmaceutical Companies
Patrik Florencio, Esq., Steven Franchetti, Seth Whitelaw, J.D., LL.M., S.J.D.
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Issue Articles

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Effectiveness, The Holy Grail of Compliance – Both the DOJ & OIG Weigh In
Sally Foroughi, Staff Writer, Life Science Compliance Update and Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
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The California Hurdle – SB 790 and Pharma
Jenny McVey, Life Sciences Manager, FRA
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LSCU SPECIAL FEATURE: Into the Nexus – Anti-Kickback Statute (“AKS”) versus Value-Driven Health Care
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Pharmaceutical and Device Manufacturers: Buyer Seller Beware
John Kelly, Matt Curley and Rob Platt
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Punting on the Issue of FCA and Statistical Sampling
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
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June

2017

June 2017: Life Science Compliance Update

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

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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 Article

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

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The Battle Over Patient Assistance Programs Heats Up
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
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Europe Moves to the Next Level in Protecting Personal Data – The GDPR & Research
Jenny McVey, Life Sciences Manager, Mark Scallon, Life Sciences Partner, FRA
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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
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Genentech & Escobar: Using Materiality to Escape False Claims Liability
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
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An FCA Journey – Allergan to Pay $53M to DOJ
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
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The 21st Century Cures Act: Is It Worth the Cost for Lifesciences?
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
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May

2017

May 2017: Life Science Compliance Update

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

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May 2017 LSCU Cover

Issue Summary

This month we go in-depth into the world of pricing. Our feature article by Nico Fiorentino reviews the new state legislation that has cropped up to deal with prescription drug pricing. We also have a second installment on the 340B program from Clay Willis and Chris Cobourn. This month they discuss the danger of duplicate discounts and diversion. On the global stage, Jenny McVey and Mark Scallon review the changes coming for medical devices in Europe under the MedTech Code. Finally, in addition to the enforcement developments, Lauren Barnett and Sean Murphy highlight ways the compliance training curriculum can help reduce risks.


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Whack a Mole – Pricing Bills Keep Popping Up Everywhere
Nicodemo (Nico) Fiorentino, Esq., Manager, Research & Compliance, for G&M Health LLC
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Global Issues

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Changing the Rules Again: The MedTech Europe Code & Third-Party Educational Support
Jenny McVey, Life Sciences Manager, Mark Scallon, Life Sciences Partner, FRA
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The Financial Risk of Waiting – 340B, Duplicate Discounts and Diversion
Clay Willis, Life Science Director and Chris Cobourn, Managing Director, Huron Life Sciences
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Improving Outcomes – Analyzing a Compliance Training Curriculum to Reduce Risk
Lauren Barnett, Senior Compliance Content Specialist and Sean Murphy, Product and Marketing Manager, PharmaCertifyTM by NXLevel Solutions
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A Port in Any Storm – Adding New Safe Harbors to the Anti-Kickback Statute
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
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Fighting Back – Pharma Objects to FDA’s Last Minute Obama-Era Guidances
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
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April

2017

April 2017: Life Science Compliance Update

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

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April 2017 LSCU Cover

Issue Summary

As we await the Easter bunny, this month we feature Chris Cobourn’s article on what pharmaceutical manufacturers need to know about 340B programs. Next, we travel around the globe to explore the recent regulatory changes that are impacting the Chinese life sciences market. Finally, we look at several trend setting enforcement actions, including Baxter’s recent cGMP False Claims Act, Teva’s FCPA settlement and the OIG’s new exclusion criteria.


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340B and You – Thoughts on Program Oversight for Pharmaceutical Manufacturers
Chris Cobourn, Managing Director, Huron Life Sciences
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Issue Articles

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Healthcare Reform – Chinese Style
Amy Greenstein, Senior Consultant and Dana Liu, Consultant, Polaris
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Project Exclusion: The OIG’s Latest Attempt to Make Its Exclusion Authority Real
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
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Going Back to the Roots of the False Claims Act – Baxter Settles cGMP Allegations
Seth Whitelaw, JD, LL.M., S.J.D., Editor and Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
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TEVA – Using Legitimate Distributor Payments to Conceal Bribes
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
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The Murky Future of Physician Owned Distributorships (“PODs”)?
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
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March

2017

March 2017: Life Science Compliance Update

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

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March 2017 LSCU Cover

Issue Summary

It’s March madness for Life Science Compliance. Medical devices are our focus this month. First, we highlight at all the new FDA device guidances issued when Obama departed the White House. We also look at how the FCA can impact devices with the Shire settlement. Also on the enforcement front, we explore whether DPA’s work as intended, as well as dive into the FY 2016 FCA recovery numbers. We finish up with two articles from Mitchell Hamline law students, Matthew Gunzehauser and Corey Hoze and one from Darren Jones of Polaris Management Partners on the future of life science compliance.


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Privacy Regulation: The Final Frontier of Life Science Compliance
Matthew Gunzenhauser
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Issue Articles

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Accountability: The shifting landscape of compliance responsibilities
Darren Jones, Managing Partner, Polaris Management Partners
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Using the Crystal Ball: What Does the Future Hold for Life Science Compliance?
Corey Hoze, J.D. Candidate, Mitchell Hamline School of Law (2018)
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A Last Hurrah as CDRH Issues Guidances Before Obama’s Departure
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
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Medical Devices & False Claims – Shire’s Settlement Is One for the History Books
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
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Do DPA’s Work? – The BioMet Case Study
Robert N. Wilkey, Esq., LSCU Staff Writer
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DOJ Has Third Highest Annual Recovery in FCA History
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
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February

2017

February 2017: Life Science Compliance Update

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

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February 2017 LSCU Cover

Issue Summary

This month we decided to look at both the compliance trends for 2017, as well as some of the “hot topics.” These hot topics include Patient Assistance Programs, Pharmaceutical Price Hikes and the new French anti-corruption law. We round out our coverage with the year-end enforcement highlights from the DOJ, OIG and FDA.


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Avoiding the Patient Assistance Program Spotlight
Kristin Rand, JD, MS, Compliance Officer, Seattle Genetics
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Issue Articles

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Product Price Hikes – When Business and Compliance Collide
Mark Scallon, Partner, FRA Life Sciences and Derek Patterson, Principal, FRA
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Anti-corruption: all roads lead to enforcement
Caroline Franco, Amy Greenstein, Darren Jones & Veronique Monjardet
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2017 Trending Towards a Banner Year for Industry Compliance
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
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Are the Safe Harbors Still Safe? – OIG Issues Final Rule
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
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Valeant and Philidor Controversy Comes to a Head
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
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FDA’s Meeting on Promotion – Can We Glimpse the Future?
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
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Antitrust and Generic Drugs – A Rare Combination
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
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January

2017

January 2017: Life Science Compliance Update

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

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January 2017 LSCU Cover

Issue Summary

Happy New Year to all our loyal subscribers and contributors! This year marks the 3rd Anniversary for the Life Science Compliance Update. Thank you! This month we focus on needs assessments, new IRO guidelines on independence, the Privacy Shield, and of course, the latest enforcement developments that impact compliance. May 2017 be a year of wondrous progress and prosperity!


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Feeling Needy – The Why, What and How of Needs Assessments
Tynan P. Olechny, MBA/MPH, CVA, Consulting Principal, PYA, and Christina L. Hummel, MBA, Senior Consultant, PYA
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Maintaining Independence & Objectivity – OIG Releases New IRO Guidance
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
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Managing Medical Inquiries in an Era of Data Analytics
Tom Gregory, Partner and Megan Ellison Manager, Fraud Investigation & Dispute Services, Ernst & Young LLP
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Sailing with a New Safe Harbor in Sight: The EU-U.S. Privacy Shield
Nicodemo (Nico) Fiorentino, Esq., Manager, Research & Compliance, for G&M Health LLC
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Planning for the Future – HHS OIG’s 2017 Work Plan
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
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Co-Payment & Deductible Waivers as Illegal Inducements
Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update
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Nursing Facilities & Kickbacks – Is the DOJ Shifting Away from Pharma?
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
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Not All Discounts Are Equal: Evaluating When Discounts May Be Construed as Unlawful
Robert N. Wilkey, Esq., Staff Writer and Dr. Seth B. Whitelaw, Editor for Life Science Compliance Update
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December

2016

December 2016: Life Science Compliance Update

Written by , Posted in December 2016 LSC Update, This Month in Compliance

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December 2016 LSCU Cover

Issue Summary

This month, we bring you the highlights from the 17th Annual Pharmaceutical and Medical Device Compliance Congress including the latest thinking from the important regulators and other thought leaders. We also explore the changing role of the Compliance Officer in two pieces from Ronald Walls and James Bones. Finally, we wrap it all up with the latest on enforcement activities including the recent Omnicare settlements.


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The Seventeenth Annual PCC: Day 1 Highlights
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
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Issue Articles

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The Seventeenth Annual PCC: Day 2 Highlights
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
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Medical Affairs and Marketing: The Evolving Role of the Compliance Officer
Ronald G. Walls, M.D., Walls Strategic Consultants
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Has Integrity Become a Commodity? – Warning Signs of Bad Behavior for Compliance Professionals
James Bone
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Omnicare’s Unwanted Spotlight Produces Mixed Results
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
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Old Weapons with A New Purpose – Using Antitrust Laws to Control Drug Pricing
Robert N. Wilkey, Esq., Staff Writer
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