Tracking Major Changes at the FDA: April 25
The agency faces database setbacks, leadership changes, and legal challenges as staff cuts reshape regulation and enforcement.
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.
FDA leadership, administration, and policy changes
FDA’s drug labeling database missing updates post-layoffs — After the April 1 RIF at the FDA, the Drugs@FDA database is now “neglected due to DOGE-directed layoffs,” with recent drug entries missing vital labeling information such as indications, contraindications, dosing, and side effects. The lack of transparency is drawing criticism from healthcare professionals and researchers.
HHS to restore FOIA offices and launch public records website — Following outcry over transparency after deep staffing cuts, HHS Secretary Robert F. Kennedy Jr. announced that all Freedom of Information Act offices will be restored, and a new website will be launched to post former FOIA requests and responses for public access.
CDER ombuds office “unavailable” following RIF — The Center for Drug Evaluation and Research’s Ombuds office, which mediates industry complaints, is currently offline as a direct result of the April 1 layoffs.
RFK Jr. to testify before Senate on HHS staff cuts — HHS Secretary Robert F. Kennedy Jr. is scheduled to testify before the Senate HELP Committee in mid-May about the agency’s recent significant workforce reductions.
New FDA leadership roles filled — Lowell Zeta named as deputy commissioner for strategic initiatives, Craig Taylor as acting chief information officer, and Timothy Schell as acting director of CVM. Heidi Rebello is no longer listed at the agency.