Inside FDA’s OCMO: Rapid Leadership Turnover, New Appointments, and What to Watch
Since Vinay Prasad, MD, MPH, assumed the FDA’s Chief Medical & Scientific Officer role and broader oversight within the Office of the Chief Medical Officer (OCMO) in mid-2025, multiple senior leaders tied to the prior CMO structure have departed or moved roles. Public reporting and official bios confirm a period of unusually fast churn—and a handful of key additions. Here’s a grounded readout with sources.
What’s confirmed
Vinay (Vinayak) Prasad was elevated to Chief Medical & Scientific Officer and (separately) tapped to lead CBER in 2025; despite a brief July exit, he was listed back in the CMO role by September. U.S. Food and Drug Administration+2Reuters+2
Ann Meeker-O’Connell left the agency; she now appears in industry roles following her tenure as Director, Office of Clinical Policy. Milken Institute
Sandra (Sandy) Retzky is no longer serving as Director of the Office of Orphan Products Development and has been reassigned within FDA, per recent trade reporting and law-firm summaries. biospace.com+1
Mallika Mundkur, MD, MPH is serving as Deputy Chief Medical Officer under OCMO. healthpolicy.duke.edu
Scott Steele, PhD—previously acting CBER director—has been reported to shift into public health preparedness leadership within OCMO. STAT
James Bertram remains Director, Office of Combination Products (OCP). dia2025globalannualmeeting.sched.com+1
Still evolving / mixed signals
Dionna Green, MD was documented as Director, Office of Pediatric Therapeutics through mid-2025; subsequent status isn’t yet clearly recorded on FDA’s site, though some public profiles suggest changes this fall. Monitor FDA org pages for updates. U.S. Food and Drug Administration+1
Why it matters
OCMO sits at the crossroads of FDA’s clinical policy, scientific integrity, rare-disease strategy, pediatric oversight, and public-health preparedness. Concentrated leadership changes can ripple into how cross-cutting policies are written, how reviews are coordinated across centers, and how disputes are escalated and resolved. Recent investigative reporting also describes internal friction tied to management style and staffing moves, underscoring the stakes for recruitment and retention. STAT
Read-through for sponsors & developers
Expect variability in interfaces. With director-level handoffs, align early on points of contact and decision pathways—especially for combination products, pediatrics, and orphan strategy.
Over-document scientific rationale. Leadership transitions can slow consensus; make your uncertainty analyses, benefit–risk logic, and post-market commitments ultra-explicit.
Track preparedness policy. If Steele’s remit within OCMO expands, anticipate renewed attention to emergency-use frameworks, shortage mitigation, and cross-center incident response. STAT
Monitor guidance calendars. Shifts in OCMO and center leadership often precede edits to clinical policy, evidence standards, and advisory committee practices.
Bottom line
OCMO is being rewritten in real time. Some exits (Meeker-O’Connell, Retzky) are confirmed; others remain in flux. New leaders (Mundkur, Steele) are stepping into influential portfolios. For program teams, the play is simple: confirm org maps before key meetings, pre-wire scientific positions, and assume extra review time while lines of authority settle.
Sources: FDA organization pages and bios; Reuters and The Guardian coverage of Prasad’s July departure/reinstatement; STAT reporting on staffing moves; Biospace and law-firm summaries on OOPD leadership changes; DIA speaker bios and FDA meeting materials for role confirmations. U.S. Food and Drug Administration+8U.S. Food and Drug Administration+8U.S. Food and Drug Administration+8
