BioCentury
ARTICLE | Regulation

It’s official: FDA says its cuts are delaying drug regulation 

Layoffs, lack of access to journals slow response to Vanda CRL appeal, FDA says

April 23, 2025 7:31 PM UTC

Evidence of the toll that firings, layoffs, and cost-cutting are taking on FDA operations is shifting from informal warnings from former agency leaders, anonymous comments from reviewers and concerns expressed by biotech executives to formal, public statements.

Given the severity of the cuts and the morale problems triggered by the ways they were carried out, the agency may be forced to triage its workload for the foreseeable future. It is likely to prioritize meeting user fee goals, a strategy that would slow and reduce the quality of activities that drug developers have come to take for granted, such as advice on development programs and meeting deadlines for meetings and administrative actions...