The FDA’s next multi-year prescription drug user fee framework is under review at the White House for 2028 through 2032, according to sources. The development follows broader political scrutiny of drug pricing and access mechanisms, and it comes as the FDA and biopharma community negotiate the operational cadence for review capacity and policy priorities. Separately, industry leaders at the Pricing and Contracting USA event cited CMS’s “open door” approach to pharmaceutical engagement around Most Favored Nation (MFN), and the CMS Innovation Center’s “Generous” model application deadline extension for manufacturers. Taken together, the updates point to a near-term focus on how pricing policy and regulatory review capacity intersect—especially for companies preparing global portfolios and government-contract strategies.