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STAT+: FDA chief pushes back on senators’ criticism, says Covid booster trials should take ‘roughly a year’
Makary told senators that staffing cuts haven't slowed down the FDA's core mission.
WASHINGTON — Lawmakers grilled Food and Drug Administration Commissioner Marty Makary on the agency’s new Covid-19 vaccine framework, the accidental firings of infant formula scientists, and the pace of regulatory approval for rare disease drugs at a Senate budget hearing on Thursday.
Makary responded at times with frustration, refuting lawmakers’ reports of slow-downs at the agency and quibbling with them over his and health secretary Robert F. Kennedy Jr.’s past, incorrect statements that the HHS layoffs did not impact scientists. Kennedy cut roughly 20,000 employees, including 3,500 workers in the FDA.
The hearing was supposed to focus on the Trump administration’s 2026 budget request, but instead covered a wide range of other FDA issues currently in the political spotlight. The FDA’s budget was not mentioned in the president’s preliminary spending package, though Makary noted in his opening remarks that the agency is requesting $6.8 billion for the upcoming year, with $3.6 billion coming from industry user fees.
