Peter Marks Forced to Resign from the FDA
“March 28th, Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research (CBER), resigned after being given the option to leave voluntarily or be fired. His resignation letter revealed his deep-rooted anger against the new administration for wanting to conduct proper safety testing on injectable products.” - Nicholas Hulscher, MPH.
In his resignation letter, Marks stated: “At the FDA, the tireless efforts of staff across the agency resulted in remarkably expediting the development of vaccines against the virus meeting the standards for quality, safety, and effectiveness expected by the American public.”
Marks also exited the FDA with a veiled threat against the American public. In an April 4, 2025, interview on CNN, Marks told his interviewer, “At any given time, there are many, many viruses that could come, things like Ebola and others that could be very dangerous to our country. We had a group that was prepared to deal with those. Additionally, I can’t go into the details, but there are manmade threats that we were prepared to deal with.”
Following publication of Mark’s letter, Vinay Prasad, MD, MPH, Professor in the Department of Epidemiology and Biostatistics at UCSF, had nothing good to say regarding Mark’s role at the FDA:
“He made some of the biggest errors in the 21st century.”
“Without randomized data regarding clinical outcomes, he repeatedly approved COVID boosters for kids as young as 6 months.”
“Without randomized data he approved these boosters for individuals who recently had COVID.”
John Gilmore, executive director of the Autism Action Network, said, “The American people are well-served by Marks’ resignation” citing the “institutional failure to use the highest standards for evaluating the safety and efficacy of products that are injected in almost all American children.”
Rushed BLA Approval for the Pfizer COVID Vaccine Boosters
In 2021, President Biden wanted to mandate COVID-19 vaccines through OSHA, and pressured the military and American companies to do the same. Unfortunately, he was faced with the fact that the vaccines were only under Emergency Use Authorization (EUA) and not a full Biologic Licensing Agreement (BLA).
In order to force mandates on Americans, the Biden Administration, with the help of Dr. Marks, rushed the BLA process for the Pfizer COVID-19 vaccine in less than four months despite warnings from senior FDA scientists.
In August of 2021 Dr. Marks pressured FDA officials, Dr. Marion Gruber and Dr. Phillip Krause to grant the full Biologic Licensing Agreement. Both objected to the Biden administration’s plan to roll out COVID-19 booster shots before conducting trials for safety and efficacy. Subsequently, Marks forced them to resign.
After media publications writing about booster shots and how the booster was necessary for the general population, on October 9, 2021, Drs. Gruber and Krause published an article in the Lancet expressing their difference in opinion. The author’s caution: “Although the idea of further reducing the number of COVID-19 cases by enhancing immunity in vaccinated people is appealing, any decision to do so should be evidence-based and consider the benefits and risks for individuals and society.”
Dr. Gruber thought boosters were necessary only for the elderly and the immunocompromised, but not necessary for the general public. She also had concerns that the shortened BLA process could undermine the credibility of the FDA. The administrative approval process, and that pressing for boosters to the vaccines for the general public, could deepen vaccine hesitancy because it signaled that the first dose of vaccine was not effective.
On June 24, 2024, a House Judiciary Subcommittee released an interim staff report titled, “Politics, Private Interests, and the Biden Administration’s Deviation from Agency Regulations in the COVID-19 Pandemic.”
According to the report, “During the Pfizer BLA review process, the FDA vaccine experts expressed concerns about injuries reported during the Pfizer EUA vaccine post-marketing evaluations, and warned that rushing the BLA review would result in lowering its robust standards, which would undermine public confidence. Testimony and FDA internal communications obtained by the Subcommittee reveal that Acting FDA Commissioner Dr. Janet Woodcock and CBER Director Dr. Peter Marks were influenced by outside pressures to rush the BLA approval, that Dr. Marks promised to deliver a BLA in the four weeks needed to meet the Biden Administration’s deadline (which was necessary step for the Biden Administration to issue vaccination mandates), and he would do so by operating as he did when evaluating the EUA vaccines in Operation Warp Speed.”
Former Acting FDA Commissioner Woodcock says she is disappointed in her involvement as it relates to vaccine-related injury and that the FDA did not do enough to address vaccine-related injuries.
Change is Needed to Restore Trust
A federal agency should act in the interest of public health and it should do so in a way that generates confidence in the result. In order to restore faith and foster confidence in our public health system, the FDA and CDC need men and women of true intellect and integrity who will adhere to strict scientific methods when testing medical products. They must adhere to randomized controlled trials which prove the safety and efficacy of vaccines being sold to the American public.
Changes must be made to restore credibility to the FDA’s once-robust vaccine approval process or future vaccines approved by the FDA may be met with increased skepticism and elevate the potential for higher vaccine hesitancy.
