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
HHS Policy Changes, Supreme Court Rulings, and the DOJ-HHS False Claims Act Working Group
In this episode, Alan Minsk, AGG Food & Drug practice chair and Life Sciences co-chair, and Brian Stimson, co-chair of the Healthcare practice and former acting general counsel and principal deputy general counsel of the U.S. Department of Health and Human Services ("HHS"), discuss three recent developments affecting life sciences companies.
Alan and Brian review the HHS policy-making process, including the formal requirements for changing policies that have undergone notice-and-comment rulemaking. They also examine the Supreme Court’s decision in Trump v. CASA, which limits nationwide injunctions and places greater responsibility on companies to take direct action to protect their interests. Finally, they address the newly formed DOJ-HHS False Claims Act Working Group, highlighting its enforcement priorities — such as drug and device pricing and kickbacks — and potential implications for payment suspensions and case dismissals.