I Wish I Knew What I Know Now: Conversations With AGG on FDA Issues
Claim This Podcastby Arnall Golden Gregory LLP
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Podcast Overview
<p>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 <a href="https://www.agg.com/services/life-sciences/">Life Sciences</a> team, offer the life sciences industry a map of the road ahead in today’s regulatory environment.</p>
Language
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Publishing Since
10/1/2020
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Recent Episodes
January 14, 2026
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 sup...
November 14, 2025
How Medicare Regulations Could Affect Access to Gender-Affirming Care: Implications for Life Sciences Companies
In this episode, AGG Life Sciences co-chair Alan Minsk and Healthcare partner Andrew Tsui examine how the Centers for Medicare & Medicaid Services ("CMS") may apply the Medicare Conditions of Participation ("COPs") to emerging areas of healthcare, including gender-affirming care — and what those developments could mean for pharmaceutical companies and drug manufacturers. They discuss how updates to COPs can impact operational requirements for healthcare providers and influence compliance...
October 7, 2025
DOJ’s Shifting Enforcement: CPB Disbanding, Counterfeit Drug Focus, and Gender-Affirming Care Investigations
In this episode, Alan Minsk, AGG Food & Drug practice chair and Life Sciences co-chair, and Gabe Scannapieco, Litigation and Healthcare partner and Life Sciences co-chair, unpack recent shifts at the U.S. Department of Justice that could reshape regulatory risk for life sciences organizations. They discuss the disbanding of DOJ’s Consumer Protection Branch ("CPB") and what the loss of centralized oversight could mean for coordinated investigations i...
13 total episodes available
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- What is I Wish I Knew What I Know Now: Conversations With AGG on FDA Issues?
<p>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 <a href="https://www.agg.com/services/life-sciences/">Life Sciences</a> team, offer the life sciences industry a map of the road ahead in today’s regulatory environment.</p> - How often does this podcast release new episodes?
This podcast updates daily.
- Where can I listen to this podcast?
This podcast is available on 4 platforms including Apple Podcasts, Spotify, and more. You can also use the RSS feed directly.
- Does this podcast accept guests?
Yes, this podcast regularly features guests.
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