Amid an unprecedented period of turmoil at the Food and Drug Administration, Commissioner Marty Makary has tapped yet another person to lead the powerful Center for Drug Evaluation and Research.
The FDA on Wednesday said Tracey Beth Høeg, a sports medicine specialist and COVID vaccine skeptic, will serve as acting director at CDER following the retirement of the current head, Richard Pazdur. Pazdur, a longtime veteran of the agency who had been hailed as a stabilizing force, stepped down just weeks after being tapped as director.
Høeg, who completed her residency in physical medicine and rehabilitation at the University of California, Davis, in 2018, joined the FDA earlier this year as a senior adviser to Makary. She had been critical of U.S. school closures during the COVID-19 pandemic and co-authored a paper that posited vaccine booster mandates were harmful to young adults.
At the FDA, she reportedly was working to change the labeling for COVID vaccines to say that the risks outweighed the benefits for males between the ages of 12 and 24. Her elevation to acting director of CDER comes as government officials under longtime anti-vaccine activist Health and Human Services Secretary Robert F. Kennedy Jr. are increasingly trying to limit the use of COVID inoculations.
The head of the FDA division that oversees vaccines, Vinay Prasad, recently sent a memo to staff tying COVID vaccines to the deaths of 10 children, citing staff “attribution” and investigative work done by Høeg and others, without providing evidence to back up that assertion. He vowed stricter rules, drawing condemnation from 12 former FDA commissioners nominated by presidents of both parties.
Høeg will become the fifth person this year to lead CDER, a division that previously had been run by only a handful of experienced veterans since its inception in 1987. The last person to hold the job for several years, Patrizia Cavazzoni, stepped down ahead of the incoming Trump administration. The acting director that followed her, Jacqueline Corrigan-Curry, departed months later. Makary named George Tidmarsh as permanent director in July but he was gone by early November amid controversy.
The turnover in the division, which oversees most new drug applications and everything from over-the-counter pills to sunscreen, has left the industry reeling. “We need organizational strength and stability at the agency,” John Crowley, the head of the Biotechnology Innovation Organization trade group, said in a statement after Pazdur’s retirement announcement. “It is time to right this ship.”
Pazdur was a 26-year veteran of the FDA who won plaudits from the industry and Wall Street as a thoughtful leader who spearheaded key initiatives such as streamlining approvals of cancer drugs. Pazdur reportedly initially turned the CDER job down and later opted for a speedy exit amid tensions with Makary and concerns about plans to give certain companies fast-pass reviews.
The chaos at CDER is emblematic of issues throughout the FDA under the second Trump administration. The agency has faced Kennedy’s mass layoffs, the resignations of key officials and reports of a toxic environment under Prasad. Prasad himself quit weeks after being named as head of the Center for Biologics Evaluation and Research and then took the job again in August.
Meanwhile, there are indications that Kennedy is unhappy with Makary’s leadership on vaccines and personnel matters. Kennedy met with Pazdur on Wednesday, suggesting that he is taking the employment drama at the FDA seriously, Axios reported. An HHS official told Axios the meeting was set up so that Kennedy could thank Pazdur for his service.
