🔗 Share this article

Given that the United States proceeds with sweeping revisions to its immunization guidelines, an unexpected name has emerged somewhat surprisingly: Høeg, a Danish American sports medicine doctor and epidemiologist who first made her name by questioning coronavirus vaccines throughout the pandemic and has concentrated on alleged fatalities after COVID-19 vaccination in her short time at the Food and Drug Administration.

Proposed Overhauls to Pediatric Vaccine Schedule

Agency leaders were set to announce sweeping revisions to the childhood vaccine schedule in December, synchronizing the US with the Danish immunization schedule, according to reports – a substantial departure that would put the US out of alignment with much of the international standard with no evidence for public health gain. This reveal has been delayed until the coming year.

Rather than the top vaccines chief, Tracy Beth Høeg is listed to address the audience at the event. She was just designated temporary leader of the FDA’s Center for Drug Evaluation and Research (CDER), the fifth person to lead the center this year.

Consolidating Power at the Regulatory Body

The acting appointment may indicate a strengthened alliance between the pharmaceutical and vaccine divisions as Høeg and Dr. Prasad solidify control at the FDA – and it points to a increased emphasis upon dismantling already-approved immunizations at the FDA.

Høeg has repeatedly called for halting some pediatric vaccine recommendations in the US in order to be more in line with Denmark's approach, a country with nationalized medicine and a population about the size of Wisconsin’s.

In her initial statements, she has kept her attention on immunizations – typically the domain of Prasad, director of the FDA’s CBER – rather than pharmaceutical oversight.

Concerns Over Qualifications

Høeg has little discernible experience in drug development, regulation or management, which has been standard for former leaders of the CBER. She has served at the FDA as a top consultant to the FDA chief and the vaccine center since earlier this year.

“It seems she lacks to have any of the qualifications” for overseeing the drug-regulation department, stated a neurologist and psychiatrist. “She’s never run a randomized controlled trial. She has no expertise in running a major agency. She lacks background in drug approvals.”

Former heads of CBER would “grasp laws and regulations and the underlying principles of pharmaceutical innovation”, said Janet Woodcock. “Clearly, she lacks the sort of resume that prior appointees who led CBER have had.”

This division has an enormous workload at the agency, she pointed out.

“Everybody just pays attention on the novel medication approvals, but the generic drug division approves a multitude of off-brand pharmaceuticals. There is also a biologic copycat branch, over-the-counter program and more, and every single one must be managed,” she noted. “The area you neglect, that’s the thing that I always told people is going to come back to haunt you.”

There is also, a significant management element to the role, which manages over 5,000 staff members. “It’s a huge management job, if you do it right,” Woodcock said.

Official Statement and Contentious Initiatives

Regarding inquiries about Dr. Høeg's credentials and whether this selection indicates more teamwork among regulatory chiefs on immunizations, a press secretary said that the “inquiries rely on flawed presumptions”.

“Her resume is consistent with the responsibilities of her role,” the official said, pointing to the months Dr. Høeg spent counseling the FDA commissioner on “medication safety and regulatory science, including computational safety modeling and vaccine surveillance”.

As the temporary head, Dr. Høeg inherits the commissioner’s controversial expedited review system, a disputed rapid therapy clearance system that apparently troubled her preceding directors. “How are these therapies being chosen for this expedited pathway? Who makes the decisions?” Howard questioned. “There is a lot of lack of transparency going on at the agency right now.”

Overall, he said, “the FDA seems to be moving towards more relaxed rules of pharmaceuticals, except for shots.”

Documented Past Work on Immunizations

Regarding immunizations, Høeg has a more established, if troubling, past, some experts have noted. She authored a analysis using unconfirmed crowd-sourced reports to assess the rate of myocarditis after COVID-19 immunization. She consulted for the state of Florida surgeon general Joseph Ladapo, who reportedly have changed statistics to indicate COVID-19 vaccines are more dangerous than they are.

Part of her “wish list” for the current administration included altering regulations for new vaccines and discontinuing “unnecessary” immunizations, she said after the election on a online show. At the agency, Dr. Høeg has allegedly floated the idea of barring teenage boys from getting Covid vaccines.

“She is an complete dogmatist who commences with her conclusions and tailors the evidence to accommodate the evidence in a very misleading, untruthful way,” Howard argued.

Gaining Influence and a “Push for Payback”

Dr. Høeg joined fellow dissenters, {like|