FDA launches hiring push to rebuild after staffing cuts

FDA officials used a town hall at the Biotechnology Innovation Organization’s annual meeting in San Diego to say the agency had been authorized to hire 2,200 people, a first step in rebuilding after last year’s staffing cuts. Lowell Zeta, acting chief of staff for FDA Commissioner Marty Makary, said the agency was already moving on the hiring push. “We are going to bring back 2,200, to start,” Zeta said.

The scale of the rebuild reflects how much capacity the agency lost. The FDA cut more than 3,000 employees last year as part of Health Secretary Robert F. Kennedy Jr.’s effort to reshape federal public health agencies, and former FDA officials warned those reductions could slow reviews of new medicine applications and make it harder to meet congressional deadlines. Zeta said about 600 of the new hires were already in onboarding and a couple hundred had already started work, a sign that the recovery has begun but is still far from complete.

The hiring plan was paired with a broader effort to steady the agency’s day-to-day operations. FDA officials said they were also taking steps to minimize attrition, including temporarily moving staff from lower-workload areas into higher-demand departments. Acting Center for Biologics Evaluation and Research director Karim Mikhail said the agency was seeing “very significant numbers applying,” while acting Center for Drug Evaluation and Research director Michael Davis said morale was improving and attrition had fallen to a historic rate.

The town hall, which listed staffing, center priorities and key initiatives among its topics, also reflected a second policy shift: the FDA is trying to ease some manufacturing requirements for cell and gene therapies while keeping quality standards in place. On Jan. 11, the agency said it was sharing information about a more flexible approach to chemistry, manufacturing and control requirements for those products, including greater flexibility in development, commercial specifications and process validation. The FDA said the Center for Biologics Evaluation and Research has approved close to 50 cell and gene therapies over the last decade, underscoring why the staffing shortage matters for patients with serious or life-threatening conditions and for developers trying to move complex products through review.

For drug makers, investors and patients, the question is not simply whether the FDA can add headcount, but whether it can rebuild the inspection, food safety and drug review muscle that was lost. The agency now has to turn hiring approvals into trained staff, settled teams and faster oversight before the backlog and the complexity of modern biologics outpace the recovery.