{‘She has zero qualifications’: this US scientific community prepares for Dr. Høeg's tenure at the FDA.

While the US undertakes unprecedented adjustments to its vaccination schedules, an unexpected name has surfaced in a surprising turn: Dr. Tracy Beth Høeg, an American of Danish descent sports physician and epidemiologist who first made her name by questioning COVID-19 shots during the global health crisis and has zeroed in on possible deaths following Covid vaccination in her recent position at the Food and Drug Administration.

Planned Changes to Childhood Immunization Program

Agency leaders had intended to reveal radical revisions to the childhood vaccination calendar in December, bringing the US with the Danish immunization schedule, it is understood – a significant shift that would place the US out of alignment with a large portion of the international standard with no evidence for improved outcomes. The planned update has been pushed back until the coming year.

In place of the top vaccines chief, Høeg is set to speak at the gathering. She was newly appointed temporary leader of the FDA’s CDER, the fifth appointee to head the center this year.

Consolidating Power at the Regulatory Body

This interim role may indicate a tighter collaboration between the drug and biologics divisions as Dr. Høeg and Dr. Prasad strengthen their influence at the FDA – and it suggests a renewed priority upon dismantling previously authorized immunizations at the FDA.

Høeg has often pushed for ending some childhood immunization guidelines in the US so as to align more like Denmark, a nation with nationalized medicine and a population about the size of the state of Wisconsin.

So far public appearances, she has continued to focus on immunizations – traditionally the responsibility of Prasad, head of the FDA’s vaccine center – instead of pharmaceutical oversight.

Doubts Over Background

Dr. Høeg has no obvious track record in medication creation, approval processes or leadership, which has been typical for past heads of the Center for Biologics Evaluation and Research. She has served at the FDA as a top consultant to the FDA chief and CBER since earlier this year.

“She doesn’t seem to have the requisite experience” for running the CDER, said Jonathan Howard. “She has not conducted a randomized controlled trial. She is not versed in managing a sizeable institution. She lacks background in industry regulation.”

Past commissioners of CBER would “understand legal statutes and the underlying principles of drug development”, commented a former acting FDA commissioner. “Clearly, she lacks the kind of background that previous people who headed the center have had.”

The drug center has an vast workload at the agency, she pointed out.

“Many people just zeroes in on the new drug program, but the generic drug division approves thousands of off-brand pharmaceuticals. There is also a biologic copycat branch, OTC medication office and other areas, and each of these need to be managed,” she explained. “The thing you neglect, that is the part that I always told people is going to come back to haunt you.”

Furthermore, a major administrative component to the job, which oversees in excess of 5,000 personnel. “It is a huge administrative position, if you do it right,” she concluded.

Official Statement and Controversial Programs

Regarding inquiries about Dr. Høeg's credentials and whether this assignment signifies greater collaboration among regulatory chiefs on vaccines, a spokesperson responded that the “concerns stem from inaccurate assumptions”.

“This background matches the responsibilities of her job,” the representative explained, pointing to the period Dr. Høeg spent advising the FDA commissioner on “drug safety and approval science, including computational safety modeling and immunization monitoring”.

As the temporary head, Høeg assumes responsibility for the agency head's new fast-track approval initiative, a contentious rapid medication authorization process that reportedly troubled her former heads. “By what process are these therapies being chosen for this fast-track system? Who makes the choices?” Dr. Howard said. “There is a lot of lack of transparency happening at the FDA right now.”

Overall, he stated, “the FDA appears to be shifting towards less stringent oversight of most medications, aside from vaccines.”

Established Track Record on Vaccines

Regarding vaccines, Høeg has a more documented, if problematic, track record, some experts observe. She published a study using unconfirmed volunteer-provided data to assess the incidence of myocarditis following Covid vaccination. She consulted for the Florida chief medical officer Dr. Joseph Ladapo, who reportedly have altered data to indicate COVID-19 vaccinations are pose a greater threat than they are.

Included in her “policy goals” for the current administration included revising rules for novel immunizations and halting “non-essential” vaccines, she remarked after the election on a online show. At the FDA, Høeg has reportedly floated the idea of barring adolescent males from obtaining Covid vaccinations.

“She’s an all-around true believer who begins with her conclusions and works backwards to accommodate the science in a very misleading, fraudulent manner,” Dr. Howard said.

Taking Control and a “Push for Payback”

Dr. Høeg became part of fellow skeptics, {like|