🔗 Share this article

As America undertakes sweeping revisions to its vaccination guidelines, a particular individual appears unexpectedly: Høeg, an American of Danish descent sports medicine doctor and epidemiologist who first made her name by expressing skepticism about COVID-19 shots in the global health crisis and has zeroed in on possible fatalities following COVID-19 immunization in her short tenure at the FDA.

Proposed Shifts to Pediatric Vaccine Program

Agency leaders had intended to announce major revisions to the pediatric vaccination calendar recently, synchronizing the US with Denmark’s vaccine program, according to reports – a substantial departure that would put the US at odds with much of the international standard with insufficient data for benefit. The announcement has been pushed back until the coming year.

Instead of the director of the vaccine center, Høeg is scheduled to address the audience at the gathering. She was recently named temporary leader of the FDA’s Center for Drug Evaluation and Research (CDER), the fifth appointee to run the center this calendar year.

Consolidating Power at the Agency

Høeg's temporary position may indicate a tighter collaboration between the pharmaceutical and vaccine centers as Dr. Høeg and Dr. Prasad consolidate power at the FDA – and it suggests a renewed priority upon reevaluating previously authorized immunizations at the FDA.

Dr. Høeg has often pushed for discontinuing some pediatric shot schedules in the US to become more similar to Denmark's approach, a country with nationalized medicine and a population about the population of Wisconsin’s.

So far comments, she has continued to focus on vaccines – typically the responsibility of Dr. Prasad, chief of the FDA’s vaccine center – instead of medication approval.

Questions Over Qualifications

Høeg has little discernible background in drug development, approval processes or management, which has been customary for former heads of the Center for Biologics Evaluation and Research. She has worked at the FDA as a key advisor to the FDA chief and CBER since earlier this year.

“She appears not to have any of the qualifications” for leading the CDER, stated a neurologist and psychiatrist. “She’s never run a randomized controlled trial. She has no expertise in running a sizeable institution. She is not an expert in industry regulation.”

Past directors of CBER would “grasp legal statutes and the underlying principles of pharmaceutical innovation”, noted Dr. Janet Woodcock. “Frankly, she lacks the kind of background that prior appointees who ran CBER have had.”

This division has an enormous portfolio at the agency, she emphasized.

“Everybody just zeroes in on the novel medication approvals, but the off-patent medication office clears a multitude of off-brand pharmaceuticals. There is also a biologic copycat branch, non-prescription drug unit and other areas, and all of those must be managed,” she noted. “The area you overlook, that is precisely what that I always told people is going to bite you.”

There is also, a major management element to the job, which supervises over 5,000 personnel. “It is a enormous management job, if you perform it correctly,” Woodcock added.

Response and Disputed Programs

In response to questions about Høeg’s credentials and whether this selection indicates greater collaboration among FDA leaders on vaccines, a representative stated that the “questions are based on inaccurate presumptions”.

“This background matches the responsibilities of her job,” the official explained, citing the period Dr. Høeg spent counseling the agency head on “medication safety and approval science, including predictive safety algorithms and vaccine surveillance”.

As the temporary head, Dr. Høeg assumes responsibility for the agency head's controversial priority voucher program, a controversial rapid medication authorization process that apparently worried her preceding directors. “By what process are these medications being selected for this voucher program? Who makes the calls?” Howard asked. “There’s a lot of lack of transparency happening at the agency right now.”

Broadly speaking, he said, “the FDA appears to be shifting towards laxer rules of most medications, with the exception of vaccines.”

Public Track Record on Immunizations

With immunizations, Dr. Høeg has a more established, if troubling, past, some experts have noted. She authored a analysis using non-validated volunteer-provided data to estimate the rate of heart inflammation after Covid immunization. She advised the state of Florida surgeon general Joseph Ladapo, who was said to have modified findings to suggest Covid vaccines are riskier than they are.

Part of her “policy goals” for the incoming administration featured changing rules for novel immunizations and ending “unnecessary” immunizations, she remarked post-election on a podcast. At the FDA, Høeg has allegedly suggested barring teenage boys from obtaining Covid vaccinations.

“She is an all-around ideologue who begins with her conclusions and tailors the evidence to accommodate the science in a extremely disingenuous, fraudulent fashion,” Dr. Howard said.

Consolidating Power and a “Revenge Tour”

Høeg became part of other contrarians, {like|