FDA Drug Czar Richard Pazdur Resigns Weeks After Taking Charge — Fueling Biotech Panic
The U.S. Food and Drug Administration — the federal agency charged with approving drugs and vaccines — is in the midst of a fresh leadership shake-up just as it faces a major public-health reckoning. According to STAT, FDA veteran Richard Pazdur has filed retirement papers, effective at the end of the month, only weeks after accepting the job as head of the agency’s drug-evaluation office.
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Pazdur had been tapped in November to lead the Center for Drug Evaluation and Research (CDER) at the urging of FDA Commissioner Marty Makary — a move widely welcomed by biotech firms, patient-advocacy groups and industry analysts who hoped his experience would bring stability during a time of upheaval. Instead, his resignation compounds what many view as regulatory instability, following a year marked by multiple high-profile exits.
The timing is particularly fraught given parallel shifts in vaccine policy. The agency’s vaccine-advisory panel, the Advisory Committee on Immunization Practices (ACIP), is scheduled this week to vote on whether to scrap or delay the long-endorsed birth-dose recommendation for the Hepatitis B vaccine — administered within 24 hours of birth.
That recommendation, in place since 1991, is credited with driving U.S. childhood hepatitis B infections to near elimination. An independent evaluation by the Vaccine Integrity Project concluded that delaying the birth dose “would increase the number of infections that could have been prevented.”
The suggested changes come as part of broader rethinking of U.S. immunization policy — and at a moment when the FDA’s drug-review arm is losing seasoned leadership. The dual developments have stirred concern among industry, public-health experts and patient advocates about growing unpredictability in regulatory and vaccine policy.
What happens next could reshape both the pace of drug approvals and the future of America’s childhood vaccine schedule. FDA and ACIP decisions expected this week are likely to trigger fresh scrutiny over whether science or politics will guide U.S. health policy.