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Given that the US undertakes unprecedented adjustments to its immunization schedules, one figure has emerged in a surprising turn: Høeg, a US-based sports medicine doctor and public health researcher who initially gained attention by questioning COVID-19 vaccinations in the global health crisis and has focused upon alleged fatalities after COVID-19 immunization in her brief tenure at the Food and Drug Administration.

Scheduled Changes to Childhood Immunization Schedule

Agency leaders had intended to announce major revisions to the pediatric immunization program recently, synchronizing the US with Denmark’s vaccine program, it is understood – a major change that would put the US out of step with much of the international standard with insufficient data for benefit. The planned update has been pushed back until the new year.

In place of Vinay Prasad, Høeg is set to address the audience at the gathering. She was newly appointed temporary leader of the FDA’s drug evaluation center, the fifth person to head the center this year.

A Shift at the FDA

This interim role could signify a strengthened alliance between the drug and biologics centers as Høeg and Dr. Prasad strengthen their influence at the regulatory agency – and it points to a greater focus upon rolling back previously authorized vaccines at the FDA.

The new acting director has frequently advocated for discontinuing certain pediatric vaccine recommendations in the US in order to be more similar to Denmark's approach, a country with nationalized medicine and a population approximately the size of the state of Wisconsin.

So far public appearances, she has kept her attention on immunizations – usually the purview of Dr. Prasad, head of the FDA’s Center for Biologics Evaluation and Research (CBER) – rather than pharmaceutical oversight.

Doubts Over Qualifications

Dr. Høeg has little discernible experience in medication creation, regulation or management, which has been standard for past heads of the biologics center. She has been employed at the FDA as a top consultant to the commissioner and CBER since earlier this year.

“It seems she lacks to have any of the qualifications” for leading the drug-regulation department, said Jonathan Howard. “She’s never run a randomized controlled trial. She lacks experience in running a major agency. She is not an expert in drug approvals.”

Previous directors of CBER would “grasp legal statutes and the research of pharmaceutical innovation”, said Dr. Janet Woodcock. “Objectively, she doesn’t have the sort of resume that previous people who ran the center have had.”

CDER has an vast portfolio at the agency, Woodcock emphasized.

“Everybody just pays attention on the novel medication approvals, but the generic program approves a multitude of generic medications. There’s a biologic copycat branch, non-prescription drug unit and more, and every single one have to be managed,” Dr. Woodcock noted. “The thing you neglect, that is the part that I always told people is going to cause problems.”

Additionally, a major leadership element to the role, which supervises over 5,000 personnel. “It is a massive leadership role, if you do it right,” Woodcock said.

Official Statement and Disputed Policies

When asked about inquiries about Høeg’s credentials and whether this assignment indicates increased cooperation among FDA leaders on immunizations, a press secretary stated that the “inquiries are based on inaccurate presumptions”.

“Her experience matches the duties of her position,” the official stated, pointing to the months Dr. Høeg spent guiding the agency head on “drug safety and approval science, including predictive safety algorithms and immunization monitoring”.

In her interim role, Høeg takes over the agency head's recently launched priority voucher program, a disputed expedited drug-approval program that reportedly concerned her predecessors. “By what process are these medications being selected for this fast-track system? Who is making the decisions?” Howard said. “There’s a lot of lack of transparency happening at the regulatory body right now.”

Broadly speaking, he remarked, “the FDA seems to be moving towards laxer regulations of most medications, except for shots.”

Documented Past Work on Vaccines

Concerning immunizations, Dr. Høeg has a more documented, if problematic, track record, critics said. She published a study using non-validated volunteer-provided data to assess the incidence of heart inflammation after Covid immunization. She advised the state of Florida top health official Dr. Joseph Ladapo, who was said to have changed statistics to suggest COVID-19 vaccines are riskier than they are.

Among her “wish list” for the current federal leadership featured altering regulations for new vaccines and discontinuing “optional” vaccines, she said post-election on a audio program. At the FDA, Dr. Høeg has allegedly proposed barring young men from getting Covid vaccinations.

“She’s an complete dogmatist who commences with her conclusions and works backwards to accommodate the science in a highly disingenuous, dishonest way,” Dr. Howard argued.

Consolidating Power and a “Push for Payback”

Høeg aligned with other contrarians, {like|