Policy & Medicine Compliance Update
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Important Message from the Editor
Since this is the final issue of the Policy & Medicine Compliance Update, I want to thank our staff of writers, our designer, and our Editorial Board members for their unwavering dedication, support, and passionate commitment to making the Update the most comprehensive, up-to-date compliance publication for life science compliance professionals.
I also want to thank all our readers and subscribers because, without you, none of this would have been possible. If you liked our publication or have suggestions on how we could have done things better, I would love to hear from you. My email is below.
February 2024 Issue
Since this is the final issue of the Policy & Medicine Compliance Update, I want to thank our staff of writers, our designer, and our Editorial Board members for their unwavering dedication, support, and passionate commitment to making the Update the most comprehensive, up-to-date compliance publication for life science compliance professionals.
I also want to thank all our readers and subscribers because, without you, none of this would have been possible. If you liked our publication or have suggestions on how we could have done things better, I would love to hear from you. My email is below.
For our last issue, we begin our coverage with the latest Helio Health Group survey of Patient Support Services and Patient Assistance Programs. The survey highlights trends in reduced funding for such programs and a corresponding decrease in compliance safeguards.
Next, we continue with the 2023 year-in-review of life science compliance developments. 2023 showcased significant updates to regulations and guidance by multiple agencies on topics ranging from effective compliance programs to promotional messaging and mergers and acquisitions.
For our final article, we examine the importance of third-party oversight and the risks associated with operating globally. Specifically, we highlight FCPA enforcement and the increased emphasis on money laundering and sanctions enforcement.
FEATURE
Helio’s Seventh Annual Patient Services Compliance Survey
Surprising Developments in 2023
By Rachel Wright and Minna Bak
Summary: The landscape of Patient Support Services and Patient Assistance Programs has noticeably changed, revealing an increase in risk. The latest Helio Health Group survey highlights these trends and reveals the pressures that are reducing funding for patient assistance programs and a corresponding decrease in compliance safeguards.
Tags: Patient Support Services, Patient Assistance Programs, Copays, Independent Charities, Call Recording, Virtual Monitoring, Live Monitoring, DOJ, Auditing, BioTek reMEDsys, Ultragenyx, HCPs, HHS-OIG
Year-IN-REVIEW
2023 Life Science Compliance Year-in-Review: Part 2
The Changing Dialog
By Dr. Seth B. Whitelaw
Summary: As expected, 2023 was a busy year for compliance professionals, and 2024 looks to bring more of the same. 2023 brought significant updates to regulations and guidance from multiple agencies on topics ranging from effective compliance programs to promotional messaging and mergers and acquisitions.
Tags: DOJ, Supreme Court, CMS, HHS-OIG, FDA, FTC, General Compliance Program Guidance, Bankruptcy, False Claims, Health Breach Notification, Privacy, Orange Book, Open Payments, LDTs, Scientific Information, Direct-to-Consumer Advertising, Mergers and Acquisitions, Purdue Pharma, Rite Aid
Governance & Operations
Across the Seas
Third-Party Oversight and the Risks of Doing Business Globally
By Kirt Kraeuter, Staff Writer
Summary: Recent statements from the Department of Justice provide ample evidence that the downward trend in overseas corruption enforcement is likely to reverse. Despite 2023 remaining near historic lows for Foreign Corrupt Practice Act (“FCPA”) enforcement activity, all signs point to increased FCPA enforcement and an increased focus on money laundering and sanctions enforcement. Compliance programs must have robust and effective third-party oversight to address all three areas.
Tags: Third Parties, Bribery, Corruption, ABAC, Due Diligence, Sanctions, Export Controls, National Security, DOJ, OFAC, Lifecycle Management, Russia, Iran, China
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]
Minna Bak: Ms. Bak is a Director with Helio Health Group.
Kirt Kraeuter: Besides being a staff writer for the Policy & Medicine Compliance Update and providing compliance advisory services, Mr. Kraeuter is an Executive Director, ERC Advisory, Policy & Learning for Novartis. He was also a Senior Director of Corporate Compliance at Moderna.
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.
Rachel Wright: Ms. Wright is a Manager and In House Counsel with Helio Health Group.
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.