By Deena Beasley
June 24 (Reuters) – The U.S. Food and Drug Administration, which cut more than 3,000 employees last year, has been authorized to hire 2,200 people, Lowell Zeta, acting chief of staff for the FDA commissioner, said on Tuesday at the BIO International Convention in San Diego.
The cuts were part of efforts by Health Secretary Robert F. Kennedy Jr. to reshape federal public health agencies.
Former FDA officials warned last year that the job reductions could disrupt the agency’s ability to review applications for new medicines. Some staffers said they were struggling to meet deadlines mandated by Congress due to the layoffs.
“We are going to bring back 2,200, to start,” Zeta said. He said around 600 new employees are in the process of onboarding and a couple hundred have started their new jobs.
The hiring spree comes as the agency said it will use a more flexible approach to manufacturing of cell and gene therapies and announced a new plan to speed early drug development. The FDA has also agreed to reassess several drugs for rare diseases that it had previously declined to approve.
“Our execution has changed a bit,” Zeta said.
Former FDA Commissioner Marty Makary resigned from the post in May after weeks of clashing with top White House and health advisers and drawing scrutiny for a series of controversial agency decisions.
“We are seeing very significant numbers applying,” said Karim Mikhail, acting director of the FDA’s Center for Biologics Evaluation and Research. He said the agency is also taking actions meant to stop current employees from leaving their jobs.
“There is a lot of effort to minimize attrition,” he said. In some cases, Mikhail said, staff are being temporarily transferred from one department to another where the workload may be higher.
Michael Davis, acting director at the FDA’s Center for Drug Evaluation and Research, said staff morale has been improving.
“I do feel that things are moving in the right direction,” he said. “Attrition is down to the historic rate.”
Davis and the other FDA officials said more work is being done to include patient needs in the drug review process, particularly for conditions with very small patient populations.
“Rare disease is an unmet need,” Zeta said. “I think that is a big focus.”
(Reporting by Deena Beasley; Editing by Andrea Ricci )
Comments