Peter Marks resigns as FDA Biologics Director amid health sector changes

USA—Dr. Peter Marks, the director of the Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER), has submitted his resignation, effective April 5, 2025.

This decision comes amid significant changes within the U.S. health sector, led by Health Secretary Robert F. Kennedy Jr.

 In his resignation letter to Acting FDA Commissioner Sara Brenner, Marks expressed his concerns about the undermining of scientific integrity and vaccine confidence, which he believes poses a serious threat to public health.

Marks has been a pivotal figure at the FDA since 2016, overseeing the regulation of vaccines, allergenic products, blood products, and cellular, tissue, and gene therapies.

 His leadership was instrumental during the COVID-19 pandemic, where he played a crucial role in the rapid development and approval of COVID-19 vaccines through Operation Warp Speed.

Despite his efforts to address Kennedy’s concerns regarding vaccine safety and transparency through public forums and collaborations with the National Academies of Sciences, Engineering, and Medicine, Marks felt that his approach did not align with the Secretary’s vision.

In his letter, Marks criticized Kennedy’s stance on vaccines, stating that the Secretary seeks not truth and transparency but rather affirmation of misinformation.

This criticism highlights the tension between Marks’ commitment to scientific evidence and Kennedy’s skepticism about vaccines.

Marks also noted the dangers of undermining confidence in well-established public health measures, citing the recent measles outbreak in Texas as an example of what happens when trust in vaccines is eroded.

The resignation of Dr. Marks has significant implications for the biotech industry and the rare disease community.

His departure is seen as unsettling, as it may impact the development of new therapies and the stability of regulatory processes.

 The Parent Project Muscular Dystrophy (PPMD) expressed deep disappointment, acknowledging Marks’ dedication to the rare disease community and his efforts to ensure patient voices were heard in regulatory decisions.

Meanwhile, Health Secretary Kennedy has been focusing on addressing the measles outbreak, emphasizing the distribution of vaccines and other treatments, such as vitamin A.

Despite these efforts, his approach to vaccines remains controversial, with critics arguing that it undermines public health by spreading misinformation.

In addition to Marks’ resignation, the Department of Health and Human Services (HHS) is undergoing a broader restructuring, including plans to lay off thousands of employees and close several agencies.

 Kennedy has framed this overhaul as a move to reduce bureaucracy and improve efficiency, aiming to “Make America Healthy Again.”

However, these changes have raised concerns among lawmakers and industry stakeholders about the potential impact on scientific standards and public health initiatives.

The involvement of new FDA Commissioner Marty Makary in Marks’ ouster has further complicated the situation.

Makary, who was recently confirmed by the Senate, signed off on Marks’ removal shortly after his private swearing-in ceremony.

This decision has sent a strong signal about the direction of vaccine policy under Kennedy’s leadership, sparking anxiety among scientists and researchers.

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