FDA Commissioner Marty Makary resigned on May 12, 2026, and FDA Deputy Commissioner for Food Kyle Diamantas was named acting commissioner. Reuters reported that Makary's departure followed weeks of pressure and clashes with White House and HHS officials, as well as scrutiny over controversial agency decisions.
The leadership change left the FDA without a permanent commissioner during intense debate over drug approvals, vaccines, tobacco products, and agency independence. Disputes have involved potentially lifesaving therapies, rare disease and cancer approvals, vaccine oversight, and broader concerns about political pressure on scientific agencies.
What advocates should watch
FDA leadership affects the pace and predictability of drug and device reviews, patient engagement, safety decisions, and regulatory transparency. Watch whether acting leadership stabilizes review standards, protects patient-centered evidence processes, and maintains clear communication with patient communities during high-stakes approval decisions.
Related: Reuters report, FDA leadership page.
Pending decisions to calendar
Leadership transitions can delay guidance, advisory committee schedules, and response letters. Advocates with open PDUFA dates should confirm whether sponsors received extension letters and whether patient listening sessions are rescheduled.
Request written confirmation of any changes to review standards that affect expanded access or compassionate-use programs.
Guides on patientadvocates.io
For step-by-step help, start with our Informed consent guide or browse related topics including Goals of care, Denied prescriptions.