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.