Life Science Compliance Update

November

2017

November 2017: Life Science Compliance Update

Written by , Posted in Home page, 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.
Topic tags:

November

2017

Coming Soon to a State or Even City Near You – Part 2 Spend Disclosure & Much More

Written by , Posted in Uncategorized

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.


   or   

Topic tags:

November

2017

Transparency Perhaps a Falling Star in the U.S. But Rising Internationally

Written by , Posted in Uncategorized

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.


   or   


November

2017

The Expanding Frontier Part 3 – PAGs in Light of the Aegerion Cases

Written by , Posted in Uncategorized

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.


   or   

Topic tags:

November

2017

The Expanding Frontier Part 2 – Navigating the Complexity of Patient Advocacy Groups

Written by , Posted in Uncategorized

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.


   or   


November

2017

Increasing the Tension – Expanding Patient Access to Investigational Medical Products

Written by , Posted in Uncategorized

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.


   or   


November

2017

Why it matters – Pharmaceutical compliance, Anti-corruption and Access to Medicine

Written by , Posted in Uncategorized

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.


   or   


October

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.

Click here to purchase this article and the entire October 2017 issue now.

October

2017

Will Your Whistle Be Heard at Home?

Written by , Posted in Uncategorized

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.


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Topic tags:

October

2017

Getting Serious About Fraud – The DOJ Charges 412

Written by , Posted in Uncategorized

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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Topic tags:

October

2017

UPDATE: Round 2 with Ohio’s Drug Sample Verification Requirements

Written by , Posted in Uncategorized

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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October

2017

The Expanding Frontier – Commercial Interactions with Patients and Patient Organizations

Written by , Posted in Uncategorized

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.


or


October

2017

Coming Soon to a State or Even City Near You – Part 1 Pricing Transparency

Written by , Posted in Uncategorized

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.


   or   

Topic tags:

October

2017

October 2017: Life Science Compliance Update

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

The full text of this 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

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.


Feature Article

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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

Arrow

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.
Topic tags:

Arrow

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.

Arrow

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.

Arrow

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.
Topic tags:

Arrow

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.
Topic tags:

October

2017

The Never-Ending Saga of Off-label Promotion

Written by , Posted in Feature article

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.


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