Position
Statement on the resignation of Dr. Peter Marks
Dr. Peter Marks is a US hematologist and oncologist who served as Director of the Center for Biologics Evaluation and Research (CBER) within the US Food and Drug Administration (FDA) since 2016. In this role, he was responsible for ensuring the efficacy and safety of biological products, including vaccines, blood products and gene therapies.
As a member of the International Sounding Board (ISB) of the National Strategy for Gene- and Cell-Based Therapies (GCT), he contributes his substantial experience and expertise in the regulatory field as well as his international perspective to the further development of the strategy. The National Strategy is an overarching initiative to strengthen the entire field of GCT for Germany, which is currently moderated and coordinated by the Berlin Institute of Health at Charité (BIH).
On March 28, 2025, Dr. Marks submitted his resignation from his position at the FDA after being given the choice of either resigning or being fired by U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. In his resignation letter, Dr. Marks criticized the Secretary's dissemination of misinformation about vaccines and emphasized the dangers to public health of undermining confidence in established vaccines.
His resignation has already caused uncertainty in the biotech-industry. John Crowley, President and CEO of the Biotechnology Innovation Organization (BIO), the world's largest biotechnology industry advocacy group, expressed concern about the loss of experienced leadership at the FDA and the potential impact on scientific standards and the development of new therapies.
Key accomplishments and achievements of Dr. Peter Marks at the FDA
Operation Warp Speed: Dr. Marks played a critical role in the development and implementation of “Operation Warp Speed,” a U.S. government initiative to accelerate the development, manufacturing and distribution of COVID-19 vaccines during President Donald Trump's first term.
Approval of gene therapies: Under his leadership, the CBER approved 22 gene therapies, enabling significant advances in the treatment of various genetic diseases.
Promoting Scientific Integrity: Dr. Marks consistently advocated for transparency and scientific rigor in drug approval and emphasized the importance of evidence-based decisions to protect public health.
Dr. Marks has demonstrated exceptional leadership and unwavering integrity during his time at the FDA. His uncompromising commitment to scientific evidence, especially at a time of growing misinformation and public uncertainty, has been a reliable compass for responsible public health policy. Whether it was the rapid but safe approval of COVID-19 vaccines or the promotion of innovative therapies such as gene therapies - his work was always guided by the goal of sustainably improving the lives of patients.
We would like to thank Dr. Marks for his outstanding commitment and tireless work in the service of public health and hope that he will continue to be available as an expert for the National Strategy for Gene- and Cell-Based Therapies.