The Post-Makary FDA Pivot: Reversals, Resubmissions, and a Return to Advisory Committees
The U.S. Food and Drug Administration (FDA) is undergoing a profound operational and regulatory shift as it works to stabilize its workforce and mend relationships with the biopharma industry. Following the spring 2026 exits of former Commissioner Marty Makary and Center for Biologics Evaluation and Research (CBER) Director Vinay Prasad, an interim leadership team is executing a massive rebuilding plan and adopting a highly collaborative, career-staff-empowered approach to regulatory reviews.
Rebuilding the Workforce After "DOGE Cuts"
At the BIO International Convention in San Diego, the FDA's acting leadership announced a major hiring initiative to recover from the intense attrition of 2025, which saw the agency lose more than 3,000 employees due to Department of Government Efficiency (DOGE) job cuts and incentivized early retirements.
According to Acting Chief of Staff and Deputy Commissioner Lowell Zeta, the FDA has been authorized to hire 2,200 people. As of late June 2026, the agency has already secured 600 new hires—with several hundred currently in onboarding clearance—and is actively recruiting for the remaining 1,600 positions.
The interim leadership is heavily focused on employee retention and restoring staff morale. Karim Mikhail, the new Acting Director of CBER, and Michael Davis, the Acting Director of the Center for Drug Evaluation and Research (CDER), are leading efforts to support and empower career reviewers. Mikhail has instituted informal meetings with departing staff to address dissatisfaction, while Davis reported that CDER’s attrition rates have successfully dropped back to historical norms.
Replimune's RP1 Receives Urgent Review After Two Rejections
The shift in leadership has had an immediate impact on the regulatory path for Replimune’s oncolytic immunotherapy RP1 (vusolimogene oderparepvec), which is being evaluated in combination with Bristol Myers Squibb’s Opdivo (nivolumab) for advanced melanoma.
RP1 was previously rejected twice under the Makary-Prasad administration. The first complete response letter (CRL) was issued in July 2025, and a second rejection followed in April 2026, with the FDA citing insufficient evidence of effectiveness. Following a "collaborative dialogue" with the new acting leadership, Replimune submitted a third Biologics License Application (BLA) resubmission.
On June 26, 2026, the FDA formally accepted the resubmission, designating it as a complete Class 1 response. The agency is treating the application as an "urgent matter," setting a PDUFA target action date of August 2, 2026, and scheduling an advisory committee meeting for late July 2026. This rapid turnaround is viewed by industry analysts as a key indicator of the FDA's renewed regulatory flexibility and desire to steady itself after a tumultuous year.
Capricor's Deramiocel Advisory Committee Scheduled
The FDA's renewed reliance on expert panels is also highlighted by the upcoming review of Capricor Therapeutics' BLA for deramiocel, an allogeneic cardiosphere-derived cell therapy for cardiomyopathy in Duchenne muscular dystrophy (DMD). The FDA's Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) is scheduled to meet on July 29, 2026, to review the application.
This high-stakes review proceeds even as Capricor is embroiled in a major legal dispute with its U.S. commercialization partner, NS Pharma, over commercial contract pricing flaws that Capricor claims would make reimbursement economically impracticable under Medicare and Medicaid (see Capricor Sues Partner NS Pharma Over Deramiocel Commercialization Pricing Flaws).