Key facts
- The FDA is authorized to hire 2,200 new employees, with hundreds already starting.
- The agency aims to improve consistency in drug application reviews.
- FDA officials are working to minimize staff attrition and improve morale.
- The FDA announced plans to speed early drug development and adopt a flexible approach to cell and gene therapies.
- Patient needs, especially for rare diseases, are a focus in drug reviews.
The U.S. Food and Drug Administration (FDA) is accelerating its hiring efforts, with authorization to bring on 2,200 new employees, as it seeks to enhance consistency in its drug review processes and speed up early drug development. Lowell Zeta, acting chief of staff for the FDA commissioner, announced at the BIO International Convention that hundreds of new hires are already onboarding, following significant staff reductions last year.
These hiring efforts come as the agency aims to address concerns raised by industry leaders like BIO CEO John Crowley, who has called for more consistent review criteria, particularly for rare disease drugs. Former FDA officials had previously warned that job cuts could disrupt the agency's ability to meet review deadlines.
FDA officials, including Karim Mikhail and Michael Davis, expressed optimism about improving staff morale and minimizing attrition. The agency is also implementing a more flexible approach to manufacturing cell and gene therapies and is prioritizing patient needs in its reviews, especially for conditions affecting small patient populations.