AGG Talks: Government Insight for Life Sciences Leaders Podcast Series
Our podcast series hosts strategic conversations at the center of life sciences, law, and policy. During each episode, AGG’s former government attorneys bring firsthand knowledge and updates from their respective agencies — such as the HHS and DOJ — and examine how the latest regulatory developments and enforcement trends impact life sciences organizations. These insider insights, paired with the practical experience of AGG’s Life Sciences team, offer the life sciences industry a map of the road ahead in today’s regulatory environment.
AGG Talks: Government Insight for Life Sciences Leaders Podcast Series
Patient Assistance Programs and the False Claims Act: Enforcement Trends and Compliance Risks for Life Sciences Companies
In this episode, AGG Life Sciences co-chair Alan Minsk is joined by AGG Healthcare and Life Sciences partner David Blank, former Senior Counsel at the HHS Office of Inspector General ("OIG"), for an in-depth discussion on Patient Assistance Programs ("PAPs"), the False Claims Act ("FCA"), and evolving enforcement priorities impacting life sciences companies.
Drawing on his experience at OIG and advising companies today, David unpacks how DOJ and OIG are approaching market access, patient support, and reimbursement arrangements — including PAPs, sponsored genetic testing, and vendor relationships. He explores enforcement trends, the role of data analytics and whistleblowers, and why state-level enforcement may represent the next major compliance challenge for the industry.
This episode builds on themes David previously addressed during an AGG-hosted webinar, "Line of Cite: FCA Enforcement Risks for Life Sciences Companies in Patient Assistance and Reimbursement Programs," and offers timely insights for companies navigating a rapidly shifting compliance landscape.