Life Science Compliance Update



May 2017: Life Science Compliance Update

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

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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.



Whack a Mole – Pricing Bills Keep Popping Up Everywhere
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.

Global Issues


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



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

Compliance Operations


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

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.



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

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.


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

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