US FDA Officials Alarmed Over Controversial New Chief Amid Fears of Science-Focused Office Being Politicized.
The Trump administration's elevation of a vaccine skeptic to head the Food and Drug Administration's Center for Drug Evaluation and Research has sent shockwaves among senior agency officials, who warn that it could irreparably damage the agency's reputation as a reliable guardian of America's drug supply.
Acting Director Dr. Tracy Beth Høeg, who previously expressed doubts about COVID-19 vaccines due to rare side effects like myocarditis, is now overseeing an office responsible for ensuring all over-the-counter and prescription drugs are safe and effective.
"I think that has contributed to a loss of trust when people are coerced to take vaccines," Dr. Høeg said in a recent advisory meeting, linking declining public trust in the US healthcare system during the pandemic to vaccine mandates and continued masking.
Her appointment has raised concerns among top officials at the FDA, who fear that she will politicize a science-focused office responsible for America's drug development pipeline. "The agency doesn't want to be seen as a partisan tool," one official said.
Industry insiders warn that companies might view the FDA less favorably and develop new products overseas if they perceive its regulatory environment as unstable.
Dr. Høeg, a sports medicine physician and epidemiologist, has been a vocal advocate for revising childhood vaccination schedules and questioning the effectiveness of certain vaccines. Her views have sparked intense debate among medical experts, with some hailing her commitment to "rigorous science" while others criticize her approach as reckless and uninformed.
The appointment has also reignited concerns about vaccine mandates and trust in the US healthcare system, which were already eroding due to the pandemic. Experts say that Dr. Høeg's views on these issues could further exacerbate public distrust in the agency and its policies.
As a representative on a Centers for Disease Control and Prevention advisory panel handpicked by Health Secretary Robert F. Kennedy Jr., Dr. Høeg has been at the forefront of efforts to revise decades-old guidance on childhood vaccinations.
The American Academy of Pediatrics says that the US vaccine schedule is based on robust evidence and is largely similar across developed countries, with some variance due to factors like disease threats, demographics, and healthcare systems.
Despite her views being at odds with medical consensus, Dr. Høeg acknowledged the effectiveness of certain vaccines in recent comments about a measles outbreak, stating that even unvaccinated children are susceptible to the disease.
In a statement announcing her appointment, Commissioner Marty Makary described her as "the right scientist" for the job, highlighting her commitment to providing high-quality evidence and advancing scientific rigor.
The Trump administration's elevation of a vaccine skeptic to head the Food and Drug Administration's Center for Drug Evaluation and Research has sent shockwaves among senior agency officials, who warn that it could irreparably damage the agency's reputation as a reliable guardian of America's drug supply.
Acting Director Dr. Tracy Beth Høeg, who previously expressed doubts about COVID-19 vaccines due to rare side effects like myocarditis, is now overseeing an office responsible for ensuring all over-the-counter and prescription drugs are safe and effective.
"I think that has contributed to a loss of trust when people are coerced to take vaccines," Dr. Høeg said in a recent advisory meeting, linking declining public trust in the US healthcare system during the pandemic to vaccine mandates and continued masking.
Her appointment has raised concerns among top officials at the FDA, who fear that she will politicize a science-focused office responsible for America's drug development pipeline. "The agency doesn't want to be seen as a partisan tool," one official said.
Industry insiders warn that companies might view the FDA less favorably and develop new products overseas if they perceive its regulatory environment as unstable.
Dr. Høeg, a sports medicine physician and epidemiologist, has been a vocal advocate for revising childhood vaccination schedules and questioning the effectiveness of certain vaccines. Her views have sparked intense debate among medical experts, with some hailing her commitment to "rigorous science" while others criticize her approach as reckless and uninformed.
The appointment has also reignited concerns about vaccine mandates and trust in the US healthcare system, which were already eroding due to the pandemic. Experts say that Dr. Høeg's views on these issues could further exacerbate public distrust in the agency and its policies.
As a representative on a Centers for Disease Control and Prevention advisory panel handpicked by Health Secretary Robert F. Kennedy Jr., Dr. Høeg has been at the forefront of efforts to revise decades-old guidance on childhood vaccinations.
The American Academy of Pediatrics says that the US vaccine schedule is based on robust evidence and is largely similar across developed countries, with some variance due to factors like disease threats, demographics, and healthcare systems.
Despite her views being at odds with medical consensus, Dr. Høeg acknowledged the effectiveness of certain vaccines in recent comments about a measles outbreak, stating that even unvaccinated children are susceptible to the disease.
In a statement announcing her appointment, Commissioner Marty Makary described her as "the right scientist" for the job, highlighting her commitment to providing high-quality evidence and advancing scientific rigor.