“Utterly Unqualified”: Embattled FDA Taps Vaccine Opponent For Top Drug Regulator Position
Dr. Tracy Beth Høeg is a familiar name on the medical fringes.
Topping off weeks of reported chaos and staffing shakeups, the Food and Drug Administration has named a prominent opponent of COVID-19 vaccines as its latest top drug regulator, drawing backlash from the scientific and medical communities.
On Wednesday, the FDA announced that Dr. Tracy Beth Høeg had been appointed to head the Center for Drug Evaluation and Research, which regulates prescription and over-the-counter drugs in the United States.
A sports medicine physician and epidemiologist who rose to political prominence amid the pandemic opposing viral mitigation measures, Høeg previously served as a special assistant to FDA Commissioner Dr. Marty Makary, an ally and fellow COVID contrarian. She also represented the FDA at meetings of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices where she questioned vaccines.
“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.
Høeg is the fifth person to head up CDER this year and the fourth of the Trump administration. Her predecessor, Dr. Richard Pazdur, a longtime agency veteran, announced his retirement on Tuesday after just weeks on the job. Pazdur had been appointed last month after Dr. George Tidmarsh, who came on in July, resigned under pressure amid a lawsuit alleging that he attempted to use his position to extort a former business associate.
Makary’s FDA has become infamous for personnel turmoil. Most senior staff have left or have been pushed out. Over the summer, Dr. Vinay Prasad, the director of the Center for Biologics Evaluation and Research and ally of Høeg and Makary, was unceremoniously fired and rehired.
The last few weeks, in particular, have seen a mix of dramatic and dire headlines about the FDA—from leadership scandals and power struggles to claims of political pressure on staffers; from accusations of “make-a-deal” drug review processes to external concerns about internal instability threatening innovation.
On Friday, public health experts were rattled by a leaked FDA memo written by Prasad containing proposed changes to the FDA’s vaccine approval process and claiming that the COVID-19 vaccines killed ten U.S. children without providing data. The supposed vaccine-induced deaths were reportedly identified by Høeg from an unverified database. The memo drew sharp criticism from a dozen former agency commissioners.
Now, just five days after the memo leak, the vaccine skeptic on whose work it was based is the nation’s top drug regulator. Høeg’s promotion has launched a fresh wave of public criticism at the FDA during an already turbulent time.
Dr. David Gorski, a surgical oncologist who runs the Science-Based Medicine blog and is a scientific advisor to the Accountability Journalism Institute, which runs Important Context, said he had grave concerns about her “lack of qualifications” for the critical role, which he said “will further degrade CDER and endanger Americans.”
“Dr. Tracy Beth Høeg is utterly unqualified to lead CDER,” Gorski told Important Context. “She has none of the deep experience in clinical trial design and management for drugs that this job requires, nor does she have deep regulatory experience.”
Virologist Angela Rasmussen, PhD, another AJI scientific advisor, offered a similarly dismal take on the FDA’s new hire, speculating that the agency’s leadership “must be either desperate or intent on ensuring FDA’s total destruction” to put Høeg, who she called a “completely unqualified and inexperienced anti-vaccine medical skeptic,” atop CDER.
Høeg does not have a background typical of CDER directors. She has no history in drug development and limited experience in government regulation. Her path to the top of a critical center inside of the FDA began with the COVID-19 pandemic, when Høeg emerged as a prominent contrarian voice on Twitter, gaining popularity with the political Right as it sought to restore economic normalcy.
Høeg became known for her focus on the supposed unintended consequences of mitigating the virus, particularly the costs for children, and won key allies—and collaborators—on the medical fringes like Makary and Prasad. When Makary was appointed head of the FDA, it was predictable that Høeg would join him in some capacity.
Despite her COVID-era work, Høeg’s resumė has overwhelmingly been focused on physical medicine and rehabilitation. When the pandemic hit, she had just gone into private practice in sports medicine in California, selling non-FDA approved platelet rich plasma injections, after completing fellowship training in 2019. Høeg had earned a PhD in epidemiology in Denmark in 2015, but her research focus had been ophthalmology.
A Wordpress blog she published about her personal life around that time advertised her “scientific interest in vision loss, vision loss during exercise, exercise, running during pregnancy, MAF training as well as nutrition and health for athletes.” She and her husband also ran a subscription coaching business for high endurance athletes. The website included her academic publications, all of which dealt with physical medicine.
As Important Context previously reported, her first COVID-related publication in PubMed came in January 2021.
“This seems like a bad idea,” remarked Colette Delawalla, CEO of the science advocacy group Stand Up for Science, regarding Høeg’s ascension. “Maybe we should be sure our political appointees overseeing life or death policy decisions have the qualifications for the work they have been appointed to do.”
It is unclear what changes may come to CDER under Høeg. Weeks before her appointment, the Trump administration announced that Tylenol taken during pregnancy was a potential cause of autism. The link was unproven, but President Trump still publicly discouraged pregnant people from taking the drug, which is one of their only options for fever reduction. Public backlash saw Health and Human Services Secretary Robert Kennedy walk back the claim.
In her new role, Høeg will be in a position to impose new regulatory requirements on drug manufacturers. Høeg has also continued serving as the FDA representative at ACIP, having participated in Thursday’s meeting about the hepatitis B vaccine.