Biopharmaceutical companies are now subject to over a half dozen federal drug price regulation programs, including the impending implementation of Medicare “negotiated pricing” pursuant to the Inflation Reduction Act.  Taken as a whole, these programs create significant gross-to-net pressures and regulatory exposure, and complicate pricing strategy and administration, for manufacturers.  While the economic importance of federal programs and the ethical imperatives to maintain patient access to therapies continue to be compelling, this program explores the potential for alternative distribution and pricing models if government program burdens become unsustainable and a company opted not to participate in them.  After a brief overview of current government pricing programs and their interactions and impacts, the session will provide an overview of the legal mechanics and consequences of terminating government program participation, emerging direct-to-consumer cash pricing models, potential modifications to patient assistance programs to ensure appropriate access, and effects on contracting and pricing.

This is Part 7 of a eleven-part series. Part 1, The New EU Product Liability Directive: A Game-Changer for Biopharma, Medtech, and Digital Health Companies, is taking place on November 3, 2025, Part 2, Life Sciences Early-Stage Dealmaking: Trends and Diligence Strategy, is taking place on November 3, 2025, Part 3, Navigating the Evolving Frontier of Women’s Health and Fertility Treatments, is taking place on November 4, 2025, Part 4, From Pharma to Produce: California’s Evolving Tort Terrain, is taking place on November 4, Part 5, AI and Life Sciences: A Collision Course, is taking place on November 4, Part 6, Recent Developments in Vaccine Product Liability Litigation, is taking place on November 5, Part 8, AI and Ethics: Navigating and Challenging Improper Use in Legal Proceedings, is taking place on November 6, Part 9, Hot Topics in Fraud and Abuse for Medical Device Manufacturers, is taking place on November 6, Part 10, Toxic Tort Litigation in the Life Sciences and Consumer Health Industry: Key Cases and Emerging Trends, is taking place on November 7, Part 11, Something New Under the Sun? Novel Preemption Topics, is taking place on November 7.

CLE Information: This webinar is presumptively approved for 1.0 CLE credit in California, Connecticut, Illinois, New Jersey, New York, Pennsylvania, Texas and West Virginia. Applications for CLE credit will be filed in Colorado, Delaware, Florida, Georgia, Ohio, and Virginia. Attendees who are licensed in other jurisdictions will receive a uniform certificate of attendance but Reed Smith only provides credit for the states listed. Please allow 4-6 weeks after the program to receive a certificate of attendance.