In a moment that will undoubtedly reverberate across the biomedical and regulatory community, Dr. Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research (CBER), has announced his resignation, effective April 5, 2025. Dr. Marks' departure is not just the exit of a respected leader; it is a profound statement about the current state of scientific integrity within one of the world's most trusted regulatory bodies.

A Legacy of Scientific Excellence and Public Service

Dr. Marks has served the FDA and the American public with unwavering dedication. Throughout his tenure, he has been at the forefront of key public health advancements, including enhancing the safety of the nation's blood supply, advancing cell and gene therapy, and guiding the nation through public health crises like COVID-19 and the mpox epidemic.

Most notably, Dr. Marks was instrumental in the rapid development and approval of COVID-19 vaccines under Operation Warp Speed. His leadership ensured that the vaccines met the rigorous safety and efficacy standards that the public has come to expect from the FDA. Under his guidance, the FDA approved 22 gene therapies, marking a new era in precision medicine and treatment for rare diseases.

A Resignation Rooted in Principle

In his resignation letter, Dr. Marks explicitly addresses his growing concern over political interference and the erosion of scientific integrity at the FDA. He notes that the agency, long regarded as the global gold standard in regulatory science, is now under threat from forces prioritizing obedience over truth.

Dr. Marks candidly states that efforts to address vaccine safety concerns have been hindered not by a lack of data or public engagement, but by a political agenda that demands subservience rather than transparency. His final words in the letter highlight the distressing shift from science-led policy to politically driven narratives, warning that this threatens not just public health in the United States but also the country's leadership in global health innovation.

A Call to Action

The resignation of Dr. Marks is a wake-up call for policymakers, the scientific community, and the public. The FDA's credibility hinges on its commitment to evidence-based decision-making, free from political interference. The implications of compromising this integrity are vast, affecting everything from public trust in vaccines to the global leadership role of the U.S. in medical innovation.

Those within the scientific and medical communities are urged to heed Dr. Marks' message. It is crucial to advocate for a regulatory environment where data, transparency, and scientific truth guide public health policies.

Moving Forward

As Dr. Marks leaves his post, the FDA and the broader medical community face a critical juncture. Upholding the principles of rigorous scientific evaluation and transparent communication is essential to maintaining public trust and safeguarding health advances.

Dr. Marks' resignation is not just an end but a call to preserve the values that underpin the FDA's mission. The scientific community must continue to strive for truth, integrity, and the unwavering commitment to public health that Dr. Marks has exemplified throughout his career.

 

 

Full Resignation Letter

Dear Dr. Brenner,

It is with a heavy heart that I have decided to resign from FDA and retire from federal service as Director of the Center for Biologics Evaluation and Research effective April 5, 2025. I leave behind a staff of professionals who are undoubtedly the most devoted to protecting and promoting the public health of any group of people that I have encountered during my four decades working in the public and private sectors. I have always done my best to advocate for their well-being and I would ask that you do the same during this very difficult time during which their critical importance to the safety and security of our nation may be underappreciated.

Over the past years I have been involved in enhancing the safety of our nation’s blood supply, in advancing the field of cell and gene therapy, and in responding to public health emergencies. In the last of these, during the COVID-19 pandemic I had the privilege of watching the vision that I conceived for Operation Warp Speed in March 2020 in collaboration with Dr. Robert Kadlec become a reality under the leadership of HHS Secretary Azar and President Trump. At FDA, the tireless efforts of staff across the agency resulted in expediting the development of vaccines against the virus, meeting the standards for quality, safety, and effectiveness expected by the American public. The vaccines undoubtedly reduced morbidity and mortality from COVID-19 in the United States and elsewhere.

Efforts currently being advanced by some on the adverse health effects of vaccination are concerning. The history of the potential individual and societal benefits of vaccination is as old as our great nation. Undermining confidence in well-established vaccines that have met the high standards for quality, safety, and effectiveness that have been in place for decades at FDA is irresponsible, detrimental to public health, and a clear danger to our nation’s health, safety, and security.

In the years following the pandemic, we have applied the same commitment to public health priorities to the development of cell and gene therapies. My hope is that during the coming years, the unprecedented assault on scientific truth that has adversely impacted public health in our nation comes to an end so that the citizens of our country can fully benefit from the advances in medical science. Though I will regret not being able to be part of future work at the FDA, I am truly grateful to have had the opportunity to work with such a remarkable group of individuals as the staff at FDA.

Sincerely,

Peter Marks, MD, PhD