HHS Names Karim Mikhail as CBER Director, Michael Davis as CDER Director in Broader FDA Leadership Shake-Up

The U.S. Department of Health and Human Services announced the selection of four senior FDA leaders: Jared Seehafer as the agency's first Deputy Commissioner for Technology and Artificial Intelligence; Michael Davis, M.D., Ph.D., as Director of the Center for Drug Evaluation and Research (CDER); Karim Mikhail, B.Pharm, MSc, as Director of the Center for Biologics Evaluation and Research (CBER); and Bret Koplow, Ph.D., J.D., as Director of the Center for Tobacco Products (CTP).¹ Three of the four — Davis, Mikhail, and Koplow — had been serving in acting capacities and are now moving into the same roles permanently.² HHS Secretary Robert F. Kennedy Jr. said, "We are building an FDA that moves faster, demands excellence, and delivers results for the American people. These leaders will drive the reforms needed to confront our nation's most serious health challenges and strengthen American leadership in medical innovation."¹ FDA Acting Commissioner Kyle Diamantas, J.D., said, "These selections are not just about filling leadership roles — they signal the direction we are heading. These leaders will help us attract and retain best-in-class talent while building the workforce and infrastructure needed to accelerate innovative across all FDA centers."¹

What does this mean for biologics regulation specifically?

Mikhail had been serving as CBER's acting director before this selection made his role permanent.¹ As CBER Director, he will lead the center responsible for regulating biological products — including vaccines, blood and blood products, and cellular and gene therapies — with a stated focus on modernizing regulatory frameworks to accelerate drug development, including for rare diseases, and strengthening vaccine safety surveillance.¹ Mikhail joined FDA in 2025 as a senior advisor in the Office of the Commissioner and spent more than two decades at Merck before that, according to his official FDA biography.³

CBER's directorship has been especially turbulent over the past 18 months. Peter Marks resigned as CBER director in late March 2025, effective April 5, citing what he called an "unprecedented assault on scientific truth."⁴ Vinay Prasad was appointed to succeed him in May 2025, then resigned in July 2025 amid criticism of his regulatory approach to Sarepta Therapeutics' gene therapy for Duchenne muscular dystrophy, before returning to the role roughly two weeks later at FDA's request.⁵ Prasad left the position for a second time in April 2026; Katherine Szarama then served briefly as acting director before Mikhail assumed the role in May 2026.⁶ In a June 2026 town hall with FDA staff, Mikhail addressed the disruption directly, telling employees, "I am with you on planet Earth. I understand very well what everybody is going through."⁷

What's changing in drug review leadership?

Davis had served as CDER's acting director, and previously as its deputy center director for about a year, before this selection.¹ He has held leadership positions within CDER's Office of New Drugs and led multidisciplinary teams responsible for drug review and the development of regulatory science and policy.¹ As CDER Director, Davis is expected to focus on three areas: increasing patient access to safe and affordable medicines, advancing the science of drug development and evaluation, and strengthening the domestic and global drug supply chain.¹

CDER has also seen repeated leadership changes since Patrizia Cavazzoni's resignation in January 2025.⁸ Tracy Beth Høeg served as acting CDER director from December 2025 until she was fired on May 16, 2026, days after Makary's resignation; Davis, then deputy director, immediately assumed acting leadership of the center.⁸

What are the two newly created or lower-profile roles?

Seehafer's position is newly created; as FDA's first Deputy Commissioner for Technology and Artificial Intelligence, he will serve as the agency's senior leader for technology, software, and AI, establishing FDA-wide strategy in those areas.¹ HHS described the role as reflecting a commitment to accelerating reliable AI innovation and modernizing federal technology infrastructure across the agency.¹ Koplow, who has served at FDA since 2011 in senior legal, policy, and leadership roles including Senior Counselor to the FDA Commissioner, was selected to lead CTP after serving as the center's acting director; his stated priorities include promoting access to less harmful alternatives for adult smokers alongside protecting minors from tobacco and nicotine products.¹

Why does the broader context matter?

These selections follow a period of significant instability at the top of the agency more broadly. Marty Makary resigned as FDA Commissioner in May 2026 after roughly 14 months in the role, following reported internal disputes over drug approval decisions and COVID-19 vaccine policy; Diamantas, previously Deputy Commissioner for Food, has served as acting commissioner since.⁹ With permanent CBER and CDER directors now confirmed, two of the agency's most consequential product centers move from acting to settled leadership.

What happens next?

HHS nominated Heidi Overton for permanent FDA Commissioner in late August 2026; her confirmation remains pending.² Once confirmed, a permanent commissioner would complete the agency's leadership transition following Makary's departure.

References

1. U.S. Department of Health and Human Services. HHS Announces Key Leadership Selections at FDA to Promote Innovation, Reform, and National Health Priorities. Press release. Published September 8, 2026. Accessed September 8, 2026.
2. FDA Names Permanent Leaders for CDER, CBER. STAT. Published September 8, 2026. Accessed September 8, 2026.
3. Karim Mikhail. FDA.gov. Accessed September 8, 2026.
4. Haigney S. FDA CBER Director Peter Marks Resigns. BioPharm International. Published March 21, 2025. Accessed September 8, 2026.
5. Haigney S. FDA Appoints New Director of CBER; Prasad Returns to Head FDA's CBER. BioPharm International. Published May 7, 2025. Accessed September 8, 2026.
6. Szarama Departs CBER; Karim Mikhail Named Acting Director. AABB. Published May 20, 2026. Accessed September 8, 2026.
7. Lawrence L. FDA CBER Chief Has a Simple Goal: Return Biologics Center to Normal. STAT. Published July 15, 2026. Accessed September 8, 2026.
8. Erman M. FDA Drug Center Head Fired After Commissioner's Exit, Replaced by Davis. Reuters, via U.S. News & World Report. Published May 16, 2026. Accessed September 8, 2026.
9. Haigney S. Martin A. Makary Becomes New FDA Commissioner. BioPharm International. Published April 1, 2025. Accessed September 8, 2026.