FDA's New Frontier: Drug Pricing Enters the Conversation

In this segment, Kirsten Axelsen, Julie Tierney of Leavitt Partners, and Rachel Turow of Skadden discuss what it means to lead a pharma company through a policy and regulatory environment that shows no sign of returning to stability.

Axelsen argues that companies must accept the U.S. pricing environment has permanently changed and focus on operational efficiency, targeting drug development to populations and disease states where value can be most clearly demonstrated, and gathering evidence earlier in the product lifecycle — even as price caps under the IRA make it harder to show value above a set ceiling. Tierney and Turow then discuss the significance of former FDA Commissioner Makary's more direct engagement with drug pricing, an arena traditionally left to CMS, Congress, and commercial payers, and how growing coordination between FDA and CMS could shape decisions like labeling and endpoint selection that carry downstream reimbursement implications.

Pharma executives and regulatory strategy teams will gain a clearer view of how to plan for a permanently altered pricing environment and a more pricing-engaged FDA.