Life Science Compliance Update

January

2018

The Monster in the Closet – New WHO Report Shines a Light on the Problem of Substandard & Falsified Medicines

Written by , Posted in Uncategorized

Gwendolyn Ball, Staff Writer, Life Science Compliance Update

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.


   or   


January

2018

Privacy Upheaval – Exploring the Impact of the GDPR on Companies Sponsoring and Managing Global Clinical Research

Written by , Posted in Uncategorized

Michelle Wilcox DeBarge, Partner, Wiggin and Dana LLP

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.


   or   

Topic tags:

January

2018

Christmas Comes Early – The FCPA Pilot Program Made Permanent

Written by , Posted in Uncategorized

Jenny McVey, Associate Director, Forensic Risk Alliance

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.


   or   

Topic tags:

January

2018

Like the Little Drummer Boy, the Beat Goes on as OIG Enforcement Shows Few Signs of Letting Up

Written by , Posted in Uncategorized

Kristen Schwendinger, Senior Managing Consultant, Berkley Research Group

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.


   or   


January

2018

A Compliance New Year’s Resolution – Assess the Company’s Culture

Written by , Posted in Uncategorized

Jenny McVey, Associate Director and Frances McLeod, Founding Partner, FRA

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.


   or   

Topic tags:

January

2018

January 2018: Life Science Compliance Update

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

The full text of the entire issue is now available to our subscribers. If you are a subscriber please log in now. You may also buy this issue by clicking on the button below.


   or   

January 2018 Issue Free Article

Click here to view this article for free.

Arrow

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
Tags: , , ,
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.

Arrow

A Compliance New Year’s Resolution – Assess the Company’s Culture
Jenny McVey, Associate Director and Frances McLeod, Founding Partner, FRA
Tags: ,
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.

Arrow

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
Tags: , , , , ,
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.

Arrow

Christmas Comes Early – The FCPA Pilot Program Made Permanent
Jenny McVey, Associate Director, Forensic Risk Alliance
Tags: , ,
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.

Arrow

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
Tags: , , ,
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.

January

2018

December

2017

LSCU Free Featured Articles

Written by , Posted in Uncategorized

Thank you for your interest in our Life Science Compliance Updates publication.  Please fill in the form below and click on the send button.  Once you have done this, you will automatically be forwarded to the page where you can download and view our free articles.

First Name (required)

Last Name (required)

Your Email (required)

Organization/Institution (required)

Telephone Number (required)

Please enter the code below: captcha

 

December

2017

December 2017: Life Science Compliance Update

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

The full text of the entire issue is now available to our subscribers. If you are a subscriber please log in now. You may also buy this issue by clicking on the button below.


   or   

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.


Arrow

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.

Arrow

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.

Arrow

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.

Arrow

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.

Arrow

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.

Arrow

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.

Arrow

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.

December

2017

Even Distributors Are Not Immune – AmeriSourceBergen’s Recent Compliance Struggles

Written by , Posted in Uncategorized

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.


   or   

Topic tags:

December

2017

Mylan’s “Banquet of Consequences” Ends for Now with the Latest EpiPen Settlement

Written by , Posted in Uncategorized

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.


   or   

Topic tags:

December

2017

The New Westward Expansion – Big Pharma Partners with Native Americans to Protect Patents

Written by , Posted in Uncategorized

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.


   or   


December

2017

The 21st Century Cures Act Moves One Step Closer to Reality with FDA’s Work Plan

Written by , Posted in Uncategorized

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.


   or   


December

2017

When Exaggeration Increases Compliance Risk – The Lessons of UHC and Inflated Risk Scores

Written by , Posted in Uncategorized

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.


   or   


December

2017

The Ongoing Struggles of Novartis’ Global Compliance Function

Written by , Posted in Uncategorized

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.


   or   


Gravityscan Badge
Menu Title