Life Science Compliance Update



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.


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.


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.


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.


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.


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.


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.


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.

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