Policy and Medicine Compliance Update May 2023 Issue Features: Regulatory Challenges in Diversity in Clinical Trials, Embracing Generative Artificial Intelligence, Novo Nordisk’s Trans-Atlantic Speech Woes, and The Sixth Circuit Tackles the Meaning of Remuneration in Kickback Cases
Policy and Medicine Compliance Update is our monthly compliance publication designed to help compliance professionals go in depth in issues and stay up to date on the latest trends. We encourage you to subscribe to our monthly publication Policy and Medicine Compliance Update.
This month we begin with a detailed examination of diversity in clinical trials. While recent FDA guidance and the new Diversity Action Plans aim to increase participant diversity, existing regulatory challenges will impact the ability to meet the new requirements.
Next, we explore the rapid advancements in generative AI, including chatGPT, and the possible impacts on life sciences. At the April Pharmaceutical Compliance Congress, AI was arguably the hottest topic.
Switching to litigation and enforcement, we examine Novo Nordisk’s recent travails in the U.S. and U.K. involving promotional activities involving its weight loss drugs. Finally, we explore a recent Sixth Circuit case that tacked the definition of remuneration in the context of AKS and FCA cases.
Articles
Regulatory Obstacles to Regulatory Requirements
By David Vulcano, LCSW, MBA, CIP, RAC, and Dr. Seth B. Whitelaw
Increased diversity in clinical trials is an important societal goal. However, achieving this goal has significant regulatory challenges. This article explores those regulatory challenges that will affect meeting the new regulatory requirements. One interesting fact in our research is that according to the data diversity in clinical trials has exponentially increased in the last decade.
Governance & Operations
Embracing Generative Artificial Intelligence
The Race to Reshape the Life Sciences Industry
By Katie Jacyna and Schuyler Tasman
Summary: Beginning in late 2022, generative AI has moved from a science fiction topic to a real tool with the potential to transform the life science industry. Therefore, life science compliance professionals must understand the technology and carefully consider its implications. This article provides a working background on generative AI and its potential uses within the industry.
Litigation & Enforcement
Novo Nordisk’s Trans-Atlantic Speech Woes
By Kirt Kraeuter, Staff Writer
Summary: Novo Nordisk’s recent promotional activities involving its weight loss drugs in the U.S. and U.K. highlight the ongoing challenges inherent in drug promotion. They also provide a reminder that there are significant consequences when a drug manufacturer’s commercial speech is deemed false or misleading.
Addressing the Fundamentals
The Sixth Circuit Tackles the Meaning of Remuneration in Kickback Cases
By Robert N. Wilkey, Esq., Senior Staff Writer
Summary: In March 2023, the Sixth Circuit Court of Appeals addressed the meaning and breadth of remuneration in connection with AKS and FCA claims. The Court placed important constraints on the ability of whistleblowers to pursue claims with questionable evidentiary validity. Moreover, the decision is consistent with other judicial rulings and DOJ policy attempting to limit the scope and reach of AKS and FCA liability.
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