The ongoing U.S. federal government shutdown has significantly impacted the FDA’s regulatory functions, particularly halting acceptance of new drug and biologic submissions that require user fees. Despite this, companies continue preparations for upcoming submissions, and some clinical trial applications remain unaffected at present. Trade groups and patient advocacy organizations urge swift resolution to prevent disruptions. Meanwhile, shifts in drug pricing policies, including Pfizer’s agreement under the ‘most favored nation’ framework, introduce pricing reforms with uncertain broader effects on market dynamics and access.