Policy and Medicine Compliance Update March 2022 Issue Features: Global Regulatory Changes, Oregon Rep Licensure, FDA vs 1st Amendment, and DOJ Yates 2.0
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Our theme for this month’s issue is change. We begin with an article from Deloitte on how the pandemic has accelerated both scientific and regulatory collaboration and innovation. The article also explores what this acceleration could help countries prepare for the next inevitable global health crisis.
Continuing with the change theme, we examine the recent developments concerning drug sales representative licensing. Recently, Oregon joined the ranks of D.C., the City of Chicago, and Nevada using licensing to control pharmaceutical sales and marketing activities.
Next, we take a journey back in time to examine the ongoing tension between the FDA’s views on off-label promotion and commercial free speech. Now that a decade has passed since the Caronia decision, we explore what has changed considering the FDA’s August 2021 Final Rule on Intended Uses.
In another respective, we explore the DOJ’s litigation policy on corporate cooperation credit and executive accountability.
Late last year, Deputy Attorney General Lisa Monaco issued an updated policy reinstating the principles of the 2015 Yates Memorandum and going even further.
Finally, we conclude this issue with the latest opioid litigation developments. First, we look at that recent victory by New York State and its implications surrounding public nuisance. We then turn our attention to the recent Native American Tribal settlement with J&J, McKesson, Cardinal Health, and AmerisourceBergen.
Feature
Never the Same Again
Tectonic Shifts in Global Life Sciences Regulations Opens Doors to Future Progress
By Oliver Steck, Paul J. Silver, Bill Greenrose, and Malka Fraiman
Summary: While the pandemic introduced many global challenges in the life sciences industry, it also brought accelerated global scientific and regulatory collaborations and innovations. As the industrial and regulatory landscape continues to evolve, it’s vital for stakeholders to have clarity on the next steps to help them prepare their people and systems for the next global crisis.
Tags: COVID-19, Health Emergencies, China, Japan, EU, WHO, EMA, Collaboration, Disruption, Digital Transformation
Litigation & Enforcement
The Trail Won’t Stop at Oregon
Continuing the Pharmaceutical Representative Licensing Journey
By Nicodemo Fiorentino, Associate Editor
Summary: Oregon now joins the ranks of the District of Columbia, the City of Chicago, and the state of Nevada imposing laws on pharmaceutical manufacturers’ representatives to obtain a license or be registered before conducting certain activities within the respective jurisdiction. This article explores the common theme behind the legislation and the driving forces leading state and local legislators to continue introducing this type of legislation.
TAGS: Sale RepRESENTATIVE, Licensing, Oregon, D.C., Chicago, Nevada, New Mexico, Opioids, Deceptive Marketing, Accountability, Drug Pricing, Transparency
An Ongoing Shipwreck
The FDA Confronts the First Amendment
By Kirt Kraeuter, Staff Writer
Summary: After the Second Circuit’s Caronia judgment in 2012, many foresaw a new day dawning where the FDA would evaluate industry communications based on truthfulness and accuracy. But after a decade, that has yet to happen. Instead, the FDA has hardened its historical position, and compliance professionals are left to calibrate their efforts between the FDA’s historical position and the courts’ more expansive theories under the First Amendment. However, tried-and-true compliance tools can help mitigate the risks and uncertainty.
Tags: First Amendment, Caronia, FDA, Off-label, Misleading, Amarin, Vascular Solutions, FRee speech, commercial speech, supreme court, intended uses
The Yates Memorandum Reborn
By Dr. Seth B. Whitelaw, Editor
Summary: The DOJ’s efforts to hold executives accountable for corporate misdeeds have a long history and mixed results despite numerous policy changes. In late 2021, Deputy Attorney General Lisa Monaco outlined a return to the controversial policy on cooperation credit first articulated by her predecessor, Sally Yates, in 2015. However, returning to an “all or nothing” approach is unlikely to fare better the second time around.
Tags: Cooperation Credit, Individual Accountability, Yates Memo, Monaco Memo, Thompson Memo, Holder Memo, Self-Disclosure, park doctrine
Notching a Win
A Shift in Legal Strategy Results in an Opioid Victory for New York State
By Robert N. Wilkey, Esq., Senior Staff Writer
Summary: At the tail end of last year, New York State secured a victory against Teva Pharmaceuticals USA, Inc., and its affiliates for their role in the opioid epidemic. Although public nuisance was again at the heart of the State’s case, New York focused on other legal theories, including state false claims and basic fraud. It appears that this blueprint may provide other states a path forward to hold opioid manufacturers and distributors accountable.
TAGS: Opioids, new York, teva, public nuisance, false claims, fraud, manufacturers, distributors
Outside the Circle
Native American Tribes Reach an ‘Epic’ Opioid Settlement with J&J & Three Distributors
By Kaitlin Fallon Wildoner, Esq., Senior Staff Writer
Summary: In early 2022, pharmaceutical manufacturer J&J and three distributors, AmerisourceBergen, McKesson, and Cardinal Health, reached a significant multi-million settlement to resolve claims that they fueled the opioid crisis throughout the Tribal Nations.
Tags: Opioids, J&J, McKesson, Cardinal Health, AmerisourceBergen, Cherokee Nation, Opioid MDL, Native Americans
From all of us here (virtually) at Policy & Medicine Compliance Update, we hope all our readers and their families are safe and healthy during these challenging times. We encourage you to subscribe and for your continuing support making us the most comprehensive, up-to-date compliance publication for life science compliance professionals.