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January 2024 Issue
January 2024
IMPORTANT MESSAGE FROM THE EDITOR:
The New Year is traditionally a time of change. This year is particularly true for the Policy & Medicine Compliance Update. The publication had a good run but will cease publication after February 2024. Thus, February 2024 will be our last issue.
Being the editor over the past eight years has been a great honor. I want to thank our writers, contributors, and Editorial Board members for their passionate commitment to making the Update the most comprehensive, up-to-date compliance publication for life science compliance professionals. I also want to thank our loyal subscribers for their unwavering support. Without you, none of this would have been possible.
Policy & Medicine will still offer news and updates on compliance issues at www.policymed.com. For any subscription-related questions, please contact Tom Sullivan at tsullivan@clinicaloptions.com.
For our next to last issue, we begin our coverage this month with Part 1 of a two-part review of important life science compliance developments in the past year. This part examines key developments in judicial review and enforcement standards under the FCA and the AKS.
Next, we explore the issue of whether a pharmaceutical company and its owners can shield themselves from civil liability for the harms alleged to have been from the sale of prescription opioids. The U.S. Supreme Court recently heard oral arguments in a case involving Purdue Pharma’s bankruptcy plan and the potential release of the Sackler family from ongoing civil lawsuits.
The remainder of this issue is devoted to two governance and operations topics. First, we review the need for a well-documented Third-Party Due Diligence program focusing on Anti-Bribery/Anticorruption issues. We also examine the role of compliance in that program. Finally, we explore the evolving role of Medical Affairs and MSLs in light of market demands and regulatory restrictions.
Articles
FEATURE
2023 Life Science Compliance Year-in-Review: Part 1
Evolving False Claims Act Enforcement Standards & New Opioid-Like MDL Dominate the Headlines
By Dr. Seth B. Whitelaw and Katherine Norris
Summary: At the outset of 2023, we anticipated a hastened pace of developments in the life sciences industry as the world emerged from the COVID-era in earnest. It was, as expected, a busy year for compliance professionals marked by significant developments in the broader legal environment shaping current and future enforcement of the False Claims Act and Anti-Kickback Statute and the contemporary authorities of the administrative state. 2023 also brought significant updates to regulations and guidance from multiple agencies on topics ranging from effective compliance programs to promotional messaging, drug pricing, mergers, and acquisitions. With an onslaught of judicial standards and regulatory guidance in a state of marked evolution, the 2023 developments have the potential for a major impact on compliance program operations now and into the future.
Tags: Kickbacks, False Claims, Supreme Court, DOJ, Knowledge Standard, Whistleblowers, Intervention, Drug Pricing, Insulin, Remuneration, Patient Assistance, Pfizer, Pharmaceutical Coalition for Patient Access, Medicaid, Medicare, Identity Theft, Chevron Doctrine, Opioids
Litigation & Enforcement
Shields Up
The Sackler Family Attempts to Avoid Opioid Civil Liability Via Bankruptcy Heads to the Supreme Court
By Robert N. Wilkey, Esq., Senior Staff Writer
Summary: The issue of whether a pharmaceutical company and its owners can shield themselves from civil liability for the harms alleged to have been from the sale of prescription opioids is before the U.S. Supreme Court. The Supreme Court’s decision will likely set a long-term precedent for life science companies regarding whether bankruptcy can be a viable liability shield from civil lawsuits.
Tags: Opioids, Supreme Court, Bankruptcy, Liability Releases, Purdue Pharma, Sacklers, OxyContin, U.S. Trustee, DOJ, Mass Tort
Governance & Operations
All Parties Are Not Created Equal
Managing High-Risk Third Parties
By Mark Pearson, Mary Dimple Thomas, and Paul Silver
Summary: Bribery and corruption are among the most prevalent issues that result in regulatory scrutiny, enforcement actions, and reputational damage. Therefore, having a specific, tailored, and well-documented Third-Party Due Diligence program focusing on Anti-Bribery/Anticorruption issues, overseen by the corporate compliance function, is becoming increasingly common. This article applies to those organizations looking to establish an ABAC TPDD program for the first time and those wishing to refresh their approach.
Tags: Third Parties, Bribery, Corruption, ABAC, Due Diligence
The Information Crossroads
The Evolving Role of Medical Affairs in Life Sciences
By Kirt Kraeuter, Staff Writer
Summary: A recent study identified Medical Science Liaisons as the most important resource for life sciences companies to convey information to healthcare professionals. This article explores the potential implications for Medical Affairs in light of current market demands and regulatory restrictions.
Tags: Medical Affairs, MSLs, Scientific Information, Scientific Exchange, SIUU, TAP, Allergan, AstraZeneca, Sereno Laboratories, FDA, DOJ, false claims, kickbacks, CIAs, PhRMA, HEOR, RWD, PIE Act
About THE Authors & Contributors[1]
Kirt Kraeuter: Besides being a staff writer for the Policy & Medicine Compliance Update and providing compliance advisory services, Mr. Kraeuter is the former Senior Director of Corporate Compliance at Moderna.
Katherine Norris: Ms. Norris, MPA, is Senior Managing Director of Ankura Consulting Group’s Healthcare and Life Sciences Compliance, Dispute, and Economics Practice. She is also a Policy & Medicine Compliance Update Editorial Board member.
Mark Pearson, Mary Dimple Thomas, and Paul Silver: Mr. Pearson is a Principal with Deloitte Financial Advisory Services LLP. Ms. Thomas is a Deloitte Financial Advisory Services India Private Limited Managing Director. Mr. Silver is a Principal with Deloitte & Touche LLP and a Policy & Medicine Compliance Update Editorial Board Member.
Dr. Seth B. Whitelaw: Dr. Whitelaw is a Senior Fellow and Adjunct Professor of Life Science Compliance at Mitchell Hamline School of Law, President & CEO of Whitelaw Compliance Group, LLC, and the Editor of the Policy & Medicine Compliance Update.
Robert Wilkey: Mr. Wilkey is the Principal Attorney at Wilkey Legal Consultants, LLC, and focuses on complex civil litigation and legal consultation involving class action matters within the pharmaceutical, medical device, environmental, and consumer protection fields. He is also a senior staff writer with the Policy and Medicine Compliance Update.
Dr. Seth B. Whitelaw
Editor
sbwhitelaw@whitelawcompliance.com
[1] The views expressed in the articles are solely those of the authors and do not reflect those of the authors’ current or former employers and clients.