Life Science Compliance Update

June

2017

COMMENTS

0

June 2017: Life Science Compliance Update

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

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June 2017 LSCU Cover

Issue Summary

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

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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.

June

2017

COMMENTS

0

The 21st Century Cures Act: Is It Worth the Cost for Lifesciences?

Written by , Posted in Legislation

Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update

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.

June

2017

COMMENTS

0

June

2017

COMMENTS

0

Chicago’s Attempt to Regulate Drug Reps – A Real Public Health Initiative or Simple Revenue Generator?

Written by , Posted in Transparency

Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update

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.

June

2017

COMMENTS

0

Genentech & Escobar: Using Materiality to Escape False Claims Liability

Written by , Posted in False Claims

Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update

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.

June

2017

COMMENTS

0

Europe Moves to the Next Level in Protecting Personal Data – The GDPR & Research

Written by , Posted in Privacy

Jenny McVey, Life Sciences Manager, Mark Scallon, Life Sciences Partner, FRA

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.

June

2017

COMMENTS

0

The Battle Over Patient Assistance Programs Heats Up

Written by , Posted in Enforcement

Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update

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.

June

2017

COMMENTS

0

White Coat” Marketing Gone Awry

Written by , Posted in Feature Article

Nicodemo (Nico) Fiorentino, Esq., Manager, Research & Compliance, for G&M Health LLC

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 to 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.

May

2017

COMMENTS

0

May 2017: Life Science Compliance Update

Written by , Posted in Home page, May 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.

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.


Feature

Arrow

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

Over the last several years, the pharmaceutical industry has seen a steady increase in state legislation targeting the cost of prescription drugs. Although the cost prescription of drugs account for a small fraction of healthcare costs within the United States, the industry cannot escape being the number one target. The 2017 legislative session makes it clear that pharmaceutical manufacturers remain surrounded on all fronts. This article examines those states that succeeded in 2016, legislation that has been introduced in 2017, and the rough road ahead.

Global Issues

Arrow

Changing the Rules Again: The MedTech Europe Code & Third-Party Educational Support
Jenny McVey, Life Sciences Manager, Mark Scallon, Life Sciences Partner, FRA
Abstract

Although the new code of conduct for member medical device and in-vitro diagnostic companies operating in the European marketplace has come into force the first day of this year, a grace period has been granted before new principles become effective. This article reviews the changes medical device and in-vitro diagnostic companies should consider implementing.

Pricing

Arrow

The Financial Risk of Waiting – 340B, Duplicate Discounts and Diversion
Clay Willis, Life Science Director and Chris Cobourn, Managing Director, Huron Life Sciences
Abstract

The purpose of this article is give manufacturers some initial background on the topics and some tools that could be considered. The review methodology described has been proven to help manufacturers and has been the starting point for developing an on-going monitoring.

Compliance Operations

Arrow

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
Abstract

Life sciences compliance departments are under constant pressure to roll out updated and comprehensive training that addresses a growing milieu of subject matter, from off-label promotion, HIPAA, and data security, to anti-bribery laws around the globe. The rush to cover all the topics across all the potential audiences can lead to a convoluted curriculum, with gaps or redundancies in terms of which audiences receive what training. Building a curriculum that appropriately addresses the company’s unique risks is an important first step, but a regularly-scheduled analysis of all content, and audiences and delivery methods, is critical to ensure on-going effectiveness against risk.

Enforcement

Arrow

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
Abstract

On December 7, 2016, the HHS Office of the Inspector General (“OIG”) approved new safe harbors to the federal anti-kickback statute (“AKS”) and amendments to the civil monetary penalty (“CMP”) rules, including recognizing new statutory exceptions, seeking to alleviate blanket prohibitions, and regulatory measures to promote access to care. In doing so, the OIG is ushering in a new era for compliance and providing life science companies some refuge from the regulatory storm.

Arrow

Fighting Back – Pharma Objects to FDA’s Last Minute Obama-Era Guidances
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update
Abstract

As we noted in last month’s issue, the FDA issued a slew of last-minute Obama Administration guidances. Overlooked among all the guidances was a Final Rule regarding tobacco products and their regulation. Several Industry groups banded together and submitted a Citizen’s Petition to the FDA, requesting a stay of the rule. This article outlines the regulation, the petition, and the FDA’s response.

May

2017

COMMENTS

0

Fighting Back – Pharma Objects to FDA’s Last Minute Obama-Era Guidances

Written by , Posted in Enforcement

Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update

As we noted in last month’s issue, the FDA issued a slew of last-minute Obama Administration guidances. Overlooked among all the guidances was a Final Rule regarding tobacco products and their regulation. Several Industry groups banded together and submitted a Citizen’s Petition to the FDA, requesting a stay of the rule. This article outlines the regulation, the petition, and the FDA’s response.

May

2017

COMMENTS

0

A Port in Any Storm – Adding New Safe Harbors to the Anti-Kickback Statute

Written by , Posted in Enforcement

Robert N. Wilkey, Esq., Staff Writer for Life Science Compliance Update

On December 7, 2016, the HHS Office of the Inspector General (“OIG”) approved new safe harbors to the federal anti-kickback statute (“AKS”) and amendments to the civil monetary penalty (“CMP”) rules, including recognizing new statutory exceptions, seeking to alleviate blanket prohibitions, and regulatory measures to promote access to care. In doing so, the OIG is ushering in a new era for compliance and providing life science companies some refuge from the regulatory storm.

May

2017

COMMENTS

0

Improving Outcomes – Analyzing a Compliance Training Curriculum to Reduce Risk

Written by , Posted in Compliance Operations

Lauren Barnett, Senior Compliance Content Specialist and Sean Murphy, Product and Marketing Manager, PharmaCertifyTM by NXLevel Solutions

Life sciences compliance departments are under constant pressure to roll out updated and comprehensive training that addresses a growing milieu of subject matter, from off-label promotion, HIPAA, and data security, to anti-bribery laws around the globe. The rush to cover all the topics across all the potential audiences can lead to a convoluted curriculum, with gaps or redundancies in terms of which audiences receive what training. Building a curriculum that appropriately addresses the company’s unique risks is an important first step, but a regularly-scheduled analysis of all content, and audiences and delivery methods, is critical to ensure on-going effectiveness against risk.

May

2017

COMMENTS

0

The Financial Risk of Waiting – 340B, Duplicate Discounts and Diversion

Written by , Posted in Pricing

Clay Willis, Life Science Director and Chris Cobourn, Managing Director, Huron Life Sciences

The purpose of this article is give manufacturers some initial background on the topics and some tools that could be considered. The review methodology described has been proven to help manufacturers and has been the starting point for developing an on-going monitoring.

May

2017

COMMENTS

0

Changing the Rules Again: The MedTech Europe Code & Third-Party Educational Support

Written by , Posted in Global Issues

Jenny McVey, Life Sciences Manager, Mark Scallon, Life Sciences Partner, FRA

Although the new code of conduct for member medical device and in-vitro diagnostic companies operating in the European marketplace has come into force the first day of this year, a grace period has been granted before new principles become effective. This article reviews the changes medical device and in-vitro diagnostic companies should consider implementing.

May

2017

COMMENTS

0

Whack a Mole – Pricing Bills Keep Popping Up Everywhere

Written by , Posted in Feature Article

Nicodemo (Nico) Fiorentino, Esq., Manager, Research & Compliance, for G&M Health LLC

Over the last several years, the pharmaceutical industry has seen a steady increase in state legislation targeting the cost of prescription drugs. Although the cost prescription of drugs account for a small fraction of healthcare costs within the United States, the industry cannot escape being the number one target. The 2017 legislative session makes it clear that pharmaceutical manufacturers remain surrounded on all fronts. This article examines those states that succeeded in 2016, legislation that has been introduced in 2017, and the rough road ahead.

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