Life Science Compliance Update

October

2017

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

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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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October

2017

Will Your Whistle Be Heard at Home?

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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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October

2017

Getting Serious About Fraud – The DOJ Charges 412

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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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October

2017

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

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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

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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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October

2017

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

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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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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.


Feature Article

Arrow

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.

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.

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.

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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