FDA's New Leader: A Controversial Shift in Vaccine and Drug Regulation

The US Food and Drug Administration (FDA) has recently appointed Tracy Beth Høeg as the acting director of the Center for Drug Evaluation and Research (CDER). This move has sparked debate, as Høeg's background is primarily in sports medicine and epidemiology, with no apparent experience in drug development, regulation, or management. Høeg's appointment comes at a time when the FDA is considering significant changes to the childhood vaccine schedule, aligning it more closely with Denmark's immunization program. This shift has raised eyebrows, as Denmark's vaccine schedule is quite different from that of the US, and the evidence supporting these changes is not clear. Critics argue that Høeg lacks the necessary qualifications for her new role. Jonathan Howard, a neurologist and psychiatrist, has pointed out that Høeg has never run a randomized controlled trial or led a large organization. Janet Woodcock, a former acting FDA commissioner, echoed these concerns, stating that Høeg does not have the background typical of past CDER directors. Despite these criticisms, Emily Hilliard, press secretary for the Department of Health and Human Services, defended Høeg's appointment. She stated that Høeg's background aligns with the responsibilities of her role, citing her work as a senior adviser to the FDA commissioner on drug safety and regulatory science. Høeg's track record on vaccines is also a point of contention. She has published studies using unconfirmed crowd-sourced reports to determine the rate of heart inflammation after Covid vaccination. She has also advised officials who have altered data to suggest that Covid vaccines are more dangerous than they are.The FDA's new priority voucher program, which allows for one-day drug approvals, has also come under scrutiny. Critics question how drugs are chosen for this program and who makes these decisions. Howard has suggested that the FDA seems to be moving towards laxer regulations for all drugs, except for vaccines. In the pandemic, Høeg and other contrarians sharply criticized the handling of Covid vaccination. They have been given high-profile positions in the Trump administration, leading some to suggest that they are consolidating power and seeking revenge for their perceived lack of recognition during the pandemic. The differences between the US and Denmark's healthcare systems and disease patterns are also significant. Denmark does not routinely vaccinate against several diseases that the US does, leading to tens of thousands of vaccine-preventable diseases each year in Denmark. The US has different disease patterns and risks, making it difficult to directly compare the two countries' vaccination schedules. Høeg has also cast doubt on the evidence behind hepatitis B vaccination, stating that officials in the second Trump administration have a low level of confidence in the benefits of these vaccines outweighing the risks. She has also questioned the safety of aluminum adjuvants in vaccines and the practice of giving multiple vaccines concurrently. In December, 12 former FDA commissioners penned a warning in the New England Journal of Medicine about the lack of transparency in announcing new changes to vaccine regulations. They argued that the current process is not generally a scientific one of open debate, which could lead to a lack of trust in the system over time.