The legal challenges to the Inflation Reduction Act are now mature. It is critical to assess, at this inflection point, what they have and have not accomplished. As cases move from the District Courts to the Courts of Appeals, key issues are rising to the forefront and setting the stage for potential resolution by the Supreme Court. The litigation has likely already influenced the way that IRA price negotiations are conducted. Government negotiatiors have been relucatant to push too hard for fear of giving litigating companies ammunition. On the other hand, the government negotiators benefit from the slow pace of litigation, which enables them to establish precedents with respect to process and prices while briefing schedules and appeals linger. All of this must be taken into account as investment and business planning decisions are made - decisions that will determine if and when the next generation of biotech therapies will be available to hopeful patients.Panelists will discuss what this means in terms of the constitutional cases (primarily, engaging on the issue of whether particiaption in the Medicare program is voluntary) and what this means in terms of the admistrative challenes to the IRA’s implementing gudielines (the central question being how much leeway the courts will give the Centers for Medicare and Medicaid Services (CMS) to interpret statutory text).