Dr. Tracy Beth Hoeg will lead the Center for Drug Evaluation and Research.
The doctor who led an investigation into deaths following COVID-19 vaccination is now the Food and Drug Administration’s (FDA) top drug regulator, the agency announced on Dec. 3.
Dr. Tracy Beth Hoeg, who had been a senior adviser to FDA leadership, has been appointed acting director of the FDA’s Center for Drug Evaluation and Research (CDER).
Dr. Richard Pazdur, a longtime FDA official who was head of the center, is retiring, the FDA said this week. Pazdur was appointed in November, after the previous center director resigned after he was accused in a lawsuit of illegally targeting a company by saying its FDA-approved product has “significant toxicity.”
CDER regulates drugs available over-the-counter and via prescriptions, including generic drugs and sunscreens. The center has nearly 5,000 employees; the FDA employs about 18,000 people.
Hoeg has worked in the past with Dr. Vinay Prasad, who heads the FDA’s Center for Biologics Evaluation and Research (CBER), which regulates vaccines and other biological products and has about 1,150 workers; and FDA Commissioner Dr. Marty Makary, including on a 2022 paper that estimated COVID-19 vaccine mandates at universities resulted in more harm than benefit.
After joining the FDA this year, Hoeg undertook an investigation into post-vaccination child deaths and determined that some were caused by a COVID-19 vaccine, Prasad said in a Nov. 28 memorandum. Other FDA staffers independently agreed on at least some of the deaths, he said.
“Dr. Hoeg is the right scientist to fully modernize CDER and finish the job of establishing a culture of cross-center coordination there,” Makary said in a statement. “At CBER, she advanced scientific rigor through her commitment to providing the public with the highest quality of evidence, including our roadmap to reduce and replace animal testing with new technologies.”
Hoeg said in a statement that CDER plays an important role in making sure medicines are safe and effective.
“This is an incredible opportunity to serve my fellow Americans,” she stated. “I am committed to transparency, honesty, and decisions based on rigorous science and ensuring important changes happen efficiently. I am humbled to support the FDA’s work to modernize and strengthen how we evaluate evidence so the public benefits from the best science.”
