Life Science Compliance Update



August 2018: Life Science Compliance Update

Written by , Posted in August 2018 LSC Update

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SPECIAL SUPPLEMENT: Adapt or Perish: Can Stem Cell Therapies Achieve Their Potential for Delivering Optimal, Cost-Effective Clinical Outcomes in An Evolving Regulatory Framework?
By George Schroeder, M.D. M.S., FACEP.; Seth Whitelaw, J.D., LL.M., S.J.D and Helmut Makosch, M.Sc.

August 2018 Issue Summary

August 2018 LSCU Cover

This month we begin with a comparison of compliance between the FINANCIAL SERVICES and life sciences industry with particular emphasis on the ROLE of the BOARD OF DIRECTORS in directing compliance activities. Next, we shift back to the OPIOID crisis with a follow-on article examining the DEA QUOTA SYSTEM and potential changes. That is followed by a look at the latest TRANSPARENCY ENFORCEMENT action by MINNESOTA against INSYS. In our Updates, Shorts & Briefs section, we continue with TRANSPARENCY and look at the new PROPOSED CHANGES to the NEW JERSEY GIFT BAN.

Moving on to RESEARCH, we start with a run-down of federal and state RIGHT-TO-TRY LAWS and their potential impact on established FDA protocols such as COMPASSIONATE USE. In this issue we also are including a special supplement devoted to the rapidly growing field of STEM CELL THERAPIES and the inevitable conflict with the established regulatory framework.  Finally, and by no means least, come hear our esteemed publisher, TOM SULLIVAN, discuss the TRENDS from four full years of OPEN PAYMENTS DATA at the upcoming 12th ANNUAL FORUM ON TRANSPARENCY AND AGGREGATE SPEND on August 22nd.  If you have never heard Tom speak about Open Payments data before, you are in for a treat!


Where Is the Grass Greener? Banking or Life Science Compliance
By: Jenny McVey, Ph.D.
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Considering both financial services and life science industries typically make it onto the top 10 list of most regulated industries in the U.S., can life science compliance professionals learn something new from banking compliance? This article explores that concept.


Swarming On The Opioid Crisis (Part 2): The DEA’s Quota System And Suspicious Order Monitoring Compliance Come Into Sharp Focus
By Katherine Norris
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This is the second article in the series exploring the major themes emerging from recent efforts to combat the ‘opioid crisis’ and their potential impact on drug manufacturers’ compliance programs. In this article, we explore the pressures facing the DEA to reduce diversion and the possibility of changes to the quota system.


State Laws Have Teeth – Minnesota Takes a Bite Out Of Insys
By Nicodemo Fiorentino
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In 1993, Minnesota became the first state to limit gifts and compensation provided by life science companies to healthcare providers. Now in 2018, with the advent of the Insys case, Minnesota is moving to enforce its statute. Although state law actions have been limited, this case is a reminder the state laws due have teeth requiring vigilance on the part of compliance professionals.


The Year of The State – The Federal Right-To-Try Law Only Creates More Questions
By David Vulcano and John R. Brown
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Following on the heels of more than 40 state legislatures, the U.S. Congress passed a federal right-to-try law giving patients access to unapproved drugs outside of the standard clinical trial and Expanded Access system. Unfortunately, the new federal law only creates more questions, which this article explores.


Ain’t Nobody Happy – New Jersey Attorney General Proposes Changes to Controversial Gift Regulation
By Nicodemo Fiorentino
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In January 2018, a New Jersey regulation that regulates interactions between pharmaceutical manufacturers and prescribers went into effect. Now the Attorney General (“AG”) is proposing new amendments.

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