Tracking Major Changes at the FDA: April 18
A leaked HHS budget reveals major FDA cuts, layoffs delay pediatric policy meeting, and biotech firms report review slowdowns.
With the flurry of FDA updates, we’ll be sharing brief, semi-regular news roundups — quick, digestible explainers to keep you on top of the latest developments. Make sure you’re on our paid tier to get each issue in full.
Here’s a brief synthesis of the most recent reporting.
Government oversight and budget cuts
Leaked White House budget plan projects deep FDA cuts — A leaked fiscal year 2026 “passback” document for HHS outlines a $595 million reduction in FDA funding compared to 2024. Big cuts hit human drugs, biologics, and toxicology centers, while medical devices see a minor increase. It remains unclear if these figures account for layoffs already executed or forecast additional ones. See an analysis of this leak on the FDA Matters blog here.
Maryland legislators push for answers on RIF fallout — Maryland lawmakers sent a letter to HHS Secretary Kennedy requesting data on how many Maryland-based FDA staff were impacted by the agency’s recent layoffs and how these cuts may affect vaccine research.
Pediatric policy meeting postponed due to staffing disruptions — FDA announced a delay in its May 2025 pediatric policy meeting, citing the need to regroup following a loss of key staff involved in organizing the event.
Leadership and workforce developments
Lowell Zeta expected to rejoin FDA — A former senior FDA official and Trump transition team advisor, Zeta is expected to return in a senior position, according to BioCentury.
RFK Jr. continues adversarial stance toward FDA and vaccines — STAT News reports that Secretary Kennedy maintains rhetoric from his anti-vaccine advocacy days, calling the FDA a “sock puppet” for industry and promoting unproven treatments.
Former FDA staff profile highlights layoff toll — STAT's Eric Boodman profiles Karen Hollitt, a West Virginia-based FDA reviewer laid off in April, showing the real human impact of recent agency-wide staffing reductions. It’s a moving piece.
Drug development and regulatory disruptions
Delays in FDA drug review functions emerge — The Wall Street Journal reports that biotech firms are now experiencing concrete delays from the FDA, including postponed trial approvals and a lack of feedback. These setbacks are forcing companies to reschedule or slow down clinical development.
Oral GLP-1 drug raises new regulatory hurdles — Eli Lilly’s orforglipron, an oral GLP-1 medication, shows strong efficacy for weight loss and diabetes. However, its format raises new challenges for FDA surveillance due to counterfeit risk and mail-order distribution.