Tracy Beth Høeg, a Danish American sports physician and epidemiologist, has been appointed as the acting director of the U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER). Høeg is known for her skepticism regarding COVID-19 vaccines and has focused on potential adverse effects associated with vaccination during her tenure. The FDA is reportedly planning significant changes to its childhood vaccination schedule, aligning it more closely with Denmark's, which may diverge from global practices without clear evidence of benefits.

Høeg's appointment follows a series of leadership changes at the FDA, with her being the fifth individual to lead CDER this year. Her collaboration with Vinay Prasad, the director of the FDA’s Center for Biologics Evaluation and Research (CBER), suggests a potential shift towards a more integrated approach between drug and vaccine regulation. Critics have raised concerns about Høeg's lack of experience in drug development and regulatory management, which contrasts with the backgrounds of previous directors.

Former FDA officials have expressed doubts about Høeg's qualifications, noting that she has not led large organizations or conducted randomized controlled trials. The FDA oversees a vast array of drug approvals, including generics and biosimilars, which require substantial regulatory expertise. Høeg's focus on vaccines, rather than broader drug regulation, has drawn scrutiny, particularly as the agency appears to be moving towards less stringent regulations for drugs while maintaining a more cautious approach to vaccines.

Høeg's past work includes advising the Florida surgeon general, who has been criticized for altering data related to vaccine safety. She has publicly questioned the safety of certain vaccines and has proposed changes to vaccination recommendations that could impact public health outcomes. This has raised alarms among health professionals, who emphasize the importance of evidence-based practices in vaccination.

The differences between the U.S. and Denmark's healthcare systems are significant, with Denmark providing universal health coverage and comprehensive prenatal care, which contrasts sharply with the U.S. system. Critics argue that Høeg's proposals may not adequately consider these disparities, potentially leading to increased health risks in the U.S. population.

Concerns about transparency and the decision-making process at the FDA have also been highlighted, with former commissioners warning that recent changes lack the rigorous scientific debate that has historically characterized vaccine regulation. This shift could undermine public trust in the FDA and its ability to ensure the safety and efficacy of vaccines and drugs.