FDA FY ’27 Budget Proposes Broad New Authorities and Reforms Across Food, Drugs and Medical Devices

The Food and Drug Administration (FDA)’s FY 2027 budget proposal, which is the first fully developed under Commissioner Marty Makary’s tenure, includes a wide-ranging collection of legislative proposals that aim to expand the agency’s authorities across nearly every major product area it regulates, including drugs, biologics, food and medical devices. While most of the budget requests funding to carry out programs within FDA’s existing mandate, these proposals are requests for Congress to legislatively alter existing programs or create new authority in statute. In this alert, we provide a high-level overview of the new authorities FDA is seeking from Congress.