FDA drug chief Tracy Beth Hoeg fired on May 17 2026 creates delays

The FDA is facing a leadership crisis with the firing of Dr. Tracy Beth Hoeg. This is the latest in a series of high-level exits that leave the agency without permanent heads for major departments.
By Newsroom | Health, USA |

The US Food and Drug Administration (FDA) is grappling with significant leadership instability, underscored by the departure of Dr. Tracy Beth Høeg, acting chief of the Center for Drug Evaluation and Research (CDER). Høeg asserts she was fired from her position, adding another layer of complexity to the agency's ongoing executive turnover. Her exit follows closely on the heels of Katherine Szarama, acting vaccines chief, who held the post for mere days.

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The FDA currently lacks permanent leadership at its highest levels, with no permanent commissioner or deputy commissioner in place. This void extends to crucial centers, with no permanent heads for two major departments following recent departures, including that of former Commissioner Dr. Marty Makary earlier this week.

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This wave of departures has created a palpable sense of demoralization among FDA staff, with reports indicating a desire among some to leave the agency. The exodus has resulted in the loss of institutional knowledge and expertise, particularly concerning public health decisions, drug approvals, and emerging medical technologies.

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Michael Davis is now stepping in as the acting director of CDER. Karim Mikhail, formerly CEO of pharmaceutical company Amarin, has taken on temporary leadership of the center.

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Høeg, a sports medicine doctor who previously voiced criticisms regarding COVID-19 shots for children, had served as acting director of CDER for approximately five months. She was also involved in drafting a scientific assessment that the Trump administration used to justify changes to the childhood vaccine schedule. Prior to her acting role, she served as a special assistant to Dr. Makary.

The departures paint a picture of an agency in flux, with analysts observing a potential slowdown in drug approval rates, coupled with an increase in rejections and review delays. This period of turmoil raises questions about the FDA's capacity to effectively navigate public health challenges and regulate the medical landscape.

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Frequently Asked Questions

Q: Why was FDA drug chief Dr. Tracy Beth Hoeg fired on May 17 2026?
Dr. Tracy Beth Hoeg, the acting chief of the Center for Drug Evaluation and Research, stated she was fired today. This move comes during a period of high turnover at the agency following the departure of Commissioner Dr. Marty Makary earlier this week.
Q: Who is replacing Dr. Tracy Beth Hoeg at the FDA CDER?
Michael Davis has been named as the new acting director of the Center for Drug Evaluation and Research. Additionally, Karim Mikhail is taking on temporary leadership responsibilities for the center.
Q: How does the FDA leadership vacuum affect drug approvals for patients?
The lack of permanent leaders is causing concerns about the agency's ability to manage its work. Analysts expect that these changes may lead to slower drug approval rates and more delays in reviewing new medical treatments.
Q: What other leaders have left the FDA recently?
Besides Dr. Tracy Beth Hoeg, the agency recently lost Commissioner Dr. Marty Makary and acting vaccines chief Katherine Szarama. These departures have left the FDA without permanent leadership in several key areas.