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# More FDA Turmoil: Drug, Biologics Leaders Removed
- URL: https://www.fdaweb.com/more-fda-turmoil-drug-biologics-leaders-removed/
- Published: 2026-05-18T12:00:00.000Z
- Updated: 2026-09-14T13:39:23.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5161163

FDA has replaced the acting leaders of CDER and CBER following the resignation of former commissioner **Marty Makary**, deepening a period of leadership instability that industry observers say could complicate regulatory decision-making for pharmaceutical companies.

**Tracy Beth Hoeg**, who had been serving as CDER acting director, said on social media that she had been fired. **Katherine Szarama**, the acting head of CBER, is leaving the leadership role but will remain at the agency.

CDER deputy director **Michael Davis** has been named acting head of the drug center, while **Karim Mikhail** will lead CBER on an interim basis. Mikhail joined FDA in 2025 as a senior advisor in the Office of the Commissioner, where he led U.S. competitiveness reforms, spanning multiple disciplines from accelerating early clinical development to on-shoring of biopharmaceutical manufacturing. He came to the agency with over two decades of leadership experience in leading both large pharmaceutical companies and small biotechnology startups across therapy areas including cardio-metabolism, respiratory, immunology, neuroscience, oncology, women's health, and anti-infectives.

Administration officials have indicated that a permanent nominee for FDA commissioner could be announced within weeks, though Senate confirmation could take months.

The rapid turnover has fueled concerns within the pharmaceutical and biotechnology industries about continuity at the agency during a period of heightened scrutiny over drug approvals, vaccines and accelerated review programs.

CDER has run through multiple acting directors since early last year, an unusually high level of leadership churn for one of the FDA’s most influential centers. Industry analysts warn that repeated management changes can affect review priorities, enforcement approaches and the pace of regulatory decisions.

The instability has been especially pronounced within CBER, which oversees vaccines, gene therapies and blood products. Over the past year, several senior officials have rotated through leadership positions, including former center director **Vinay Prasad**, whose tenure was marked by public controversy and repeated departures and returns to the agency.

While career scientists and reviewers provide operational continuity inside the FDA, pharmaceutical companies often rely heavily on stable senior leadership to interpret regulatory priorities and maintain predictable review standards.