Former FDA Commissioner Scott Gottlieb expressed significant concerns regarding recent changes to U.S. public health policy during an interview on CBS’s “Face the Nation” on December 7, 2025. The discussion centered on a controversial decision by the Centers for Disease Control and Prevention (CDC) to delay the administration of the Hepatitis B vaccine for newborns from within 24 hours of birth to two months old. This policy shift, approved by the CDC’s Advisory Committee on Immunization Practices (ACIP) with an 8-3 vote, has raised alarms among pediatric health experts.
In his dialogue with host Margaret Brennan, Gottlieb highlighted the implications of this decision for newborns. He explained that while children over five years old have a 95% chance of clearing a Hepatitis B infection, the situation is markedly different for infants. He noted that approximately 90% of newborns who contract the virus during delivery will develop a chronic infection. This chronic infection increases the risk of severe health issues, including liver disease and cancer, with a potential mortality rate of 25%.
Gottlieb underscored the importance of the birth dose, stating it is almost 99% effective in preventing chronic infection. He emphasized that the CDC’s rationale for the delay—suggesting that Hepatitis B is primarily transmitted through sexual contact or dirty needles—is misleading. Gottlieb pointed out that many mothers are not tested for the virus during pregnancy, and the tests can yield false negative results.
The former commissioner expressed concern over the composition of the ACIP, suggesting that many members are anti-vaccine activists. According to Gottlieb, this shift in the committee’s makeup has led to decisions that compromise the integrity of public health recommendations. He warned that this could have lasting impacts, as numerous states rely on ACIP guidelines for their own vaccination policies.
In a broader context, Gottlieb addressed the implications of recent regulatory changes within the FDA, where a new requirement for vaccine approval has emerged. He noted that the FDA now mandates one specific study to secure approval for vaccines, a move that could hinder the development of future vaccines. This policy change has caused a notable sell-off in biotech stocks, reflecting investor concerns about the future of vaccine innovation.
Gottlieb criticized the FDA’s decision to move away from established practices that allow for the approval of vaccines based on antibody response, known as immuno-bridging studies. He argued that this approach is essential for timely updates to vaccines, particularly as viral strains evolve.
In light of these developments, 12 former FDA commissioners have voiced their concerns over the changes, citing potential risks to public health. The FDA’s recent memo, which suggested a link between certain deaths and the COVID-19 vaccine, has intensified scrutiny of the agency’s current leadership and policies. Gottlieb emphasized the need for transparency and thorough investigation of vaccine safety data, advocating for public access to the case-level analyses that inform these critical decisions.
As the conversation around vaccination policy continues to evolve, Gottlieb’s insights underscore the complex interplay between public health, regulatory practices, and the need for scientific integrity in decision-making. The impact of these policies on future generations remains a pressing concern for healthcare professionals and families alike.
