Washington D.C. – Tracy Beth Høeg’s first day as acting director of the Trump FDA’s Center for Drug Evaluation and Research (CDER)–the department responsible for reviewing and regulating the safety and effectiveness of Rx and OTC drugs—has already been met with red flags even from colleagues within the department about “her ability to oversee drug regulation without bias”.
Høeg is now the fifth person to lead the agency in a chaotic year defined by mass layoffs, staff revolt, and risky, unfounded policy moves as Donald Trump and HHS Secretary RFK Jr. have put extreme political pressure on the agency to baselessly scrutinize vaccine safety. Early reporting indicates Høeg embraces the Trump-RKF Jr. cavalier approach to critical health issues, where “ political decisions lead, and evidence follows.”
One agency source told CBS News: “Putting Tracy Beth in charge is like dropping an atom bomb,” […] adding that multiple top-level officials are preparing resignations. “It’s an extinction level event. Tracy Beth Høeg has never supervised a drug review, never has conducted a clinical trial. She doesn’t understand laws and regulations.”
“The Trump FDA desperately needs a shot of credibility and stability, but instead the administration is further marginalizing health experts in pursuit of unfounded vaccine skepticism with Tracy Beth Høeg at the helm,” said Kayla Hancock, director of Public Health Watch, a project of Protect Our Care. “According to her colleagues, Høeg is prone to chasing after her own biases in favor of unproven claims, which is the last quality you want in a person tasked with objective oversight of drug regulation. How can someone with a history of trying to undermine access to long-proven safe and effective vaccines be trusted to ensure our families can get the best treatments and health outcomes? So long as Trump and RFK Jr.’s priority is giving official validation to pseudoscience and conspiracy theories, our public health is not one.”
KEY POINTS from STAT News’ profile of Tracy Beth Høeg, ‘FDA staff fear Tracy Beth Høeg will bring bias and instability to embattled drug center’:
On Monday, Høeg will become acting director of the FDA’s Center for Drug Evaluation and Research. It’s a role where dispassionately reviewing complicated scientific evidence about the benefits and harms of medical treatments is paramount. […] But in her nine months as scientific adviser to FDA Commissioner Marty Makary, Høeg’s track record has raised questions about her ability to oversee drug regulation without bias.
Already, Høeg has taken steps to limit access to Covid shots, to cut career staff out of vaccine surveillance research, and to revisit the safety of monoclonal antibodies that protect infants against RSV. She has spoken at length about the risks of certain antidepressants for pregnant people without considering the benefits, and advised the Centers for Disease Control and Prevention to cut down its childhood vaccine schedule. She is seeking radical change, often based on thin evidence.
“She is interpreting reality in a way that supports what she already believes,” said an official in FDA’s drug center who has worked with Høeg.
STAT interviewed more than 15 FDA sources, public health experts, industry players, and colleagues of Høeg, and reviewed clinical data along with Høeg’s blog posts and interviews, to get a sense of how she may lead the drug center. […] Høeg will be the fifth person to direct the center this year as the agency grapples with personnel upheaval.
Staffers, as well as industry and patient stakeholders, desperately want the drug center to be stable again. Based on STAT’s reporting, Høeg may not bring that stability.
Nine agency sources said employees in the drug center are distraught by the choice because of Høeg’s lack of experience and history of overruling career staff. Several have said there could be mass resignations after she takes over. […]
Traditionally, the CDER director position has gone to civil servants with significant regulatory, drug development, and management experience. Høeg does not have any of those qualifications. But she is close with Makary, a bond forged by their mutual skepticism of Covid boosters and other countermeasures, and has quickly become one of the most important people at the agency.
Høeg has become deeply and unusually involved in the review and surveillance of products that she believes might be harmful. Six agency officials told STAT that staff take safety concerns seriously. But they don’t trust Høeg to evaluate data objectively and to apply the same level of scrutiny to all drug products.
Høeg is taking the job after longtime cancer regulator Richard Pazdur decided to retire less than a month into his tenure as CDER director. His decision stemmed from concerns that Makary and other top leaders were meddling with the agency’s scientific process, STAT previously reported.
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Høeg, a sports medicine physician and Ph.D. epidemiologist, was a vocal opponent of Covid-19 pandemic policies, such as masking, school closures, and vaccine mandates. […]
But agency sources told STAT it’s not clear that Høeg recognizes her own bias.
Since Makary appointed Høeg in April, she’s made reshaping vaccine regulation a priority. The move is notable in a health administration led by Kennedy, who has spent two decades harshly criticizing vaccines. […] Høeg has made her opinions, and her connections to critics of the products outside of the agency, known to staff.
“She has this small, but I think meaningful, history so far that has repeatedly sidelined evidence in favor of her own reanalysis or own views with a small circle of like-minded skeptics,” said Katelyn Jetelina, an epidemiologist who specializes in health communications. “Americans deserve better than that.” […]
A STAT opinion piece recently noted that Høeg as a physician has offered unproven stem cell therapies to patients, despite her stated focus on safety. […]
Another product that Høeg wants to revisit is monoclonal antibodies that protect babies against respiratory syncytial virus, or RSV. This review was first reported by Reuters. These products have come under attack by some members of Kennedy’s handpicked vaccine advisory panel and by vaccine critics more generally.
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