Peter Marks Resigns From FDA As HHS Fires 10,000 Employees In Reorganization Effort

Dr. Peter Marks, an FDA official involved in Operation Warp Speed, has resigned from his position as director of the Center for Biologics Evaluation and Research (CBER). Marks started his career at the FDA as deputy director of the CBER in 2012 and has been the director since 2016. CBER is tasked with ensuring biological products, including vaccines, are safe and effective.

News outlets have reported that Dr. Marks was offered the option of resigning or being fired by HHS Secretary Robert F. Kennedy Jr. The Associated Press reports that the information came from a “former FDA official familiar with the discussions” who asked to remain anonymous. Kennedy has said one of his primary goals in running HHS is to root out conflicts of interest and the revolving door between regulators and the companies they are tasked to regulate.

Marks wrote a resignation letter criticizing Kennedy’s approach to public health. He wrote, “As you are aware, I was willing to work to address the Secretary’s concerns regarding vaccine safety and transparency by hearing from the public and implementing a variety of different public meetings and engagements with the National Academy of Sciences, Engineering, and Medicine. However, it has become clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies.”

Multiple media outlets have reported that an HHS official released a statement saying that if Peter Marks “does not want to get behind restoring science to its golden standard and promoting radical transparency, then he has no place at FDA under the strong leadership of Secretary Kennedy.”

Dr. Vinay Prasad wrote a Substack post in response to Marks’ resignation and called him a “mediocre academic.” Prasad also wrote, “Peter Marks was one of the most dangerous, pro-pharma regulators of the 21st century. He is leaving and crafting a narrative that portrays him as a saint. That’s natural. But what is shocking is that the media is so uncritical, and not honest about his actions. The same media that lied about lab leak, masks, and all things covid is lying about Peter Marks.”

Prasad called out the media for lying about Kennedy pressuring Marks to resign without any specific action cited in their reports. Prasad criticized Marks for approving booster shots for 6-month-old children without any randomized data. The United States is still an outlier for the CDC’s recommendation that all healthy children as young as 6 months should get the COVID-19 vaccine despite low risk of mortality and severe outcomes from the virus.

Prasad also pointed out the obstacle the Biden administration faced when trying to mandate the COVID-19 vaccine for OSHA and military members. The vaccines were available via Emergency Use Authorization (EUA) rather than a biologic licensing agreement (BLA). There was some dispute about whether vaccines could be legally mandated with only an EUA.

Marks reportedly pressured Dr. Marion Gruber and Dr. Philip Krause to cut corners and approve the vaccine via BLA. When the two officials refused to bend to the pressure, Marks pressured them to resign. They resigned in 2021. Both Gruber and Krause stated this under oath to the House Judiciary Subcommittee on the Administrative State, Regulatory Reform, and Antitrust.

The press release from June 2024 concluded “The FDA succumbed to the Biden Administration’s pressure to act beyond its authority, which may have long-term impacts on the agency’s ability to confidently serve the American public. This poor policy by the Biden Administration reveals many significant problems related to accountability and good decision-making in the administrative state that warrant legislative reform.”

Dr. Gruber explained some of the tactics Dr. Peter Marks and Janet Woodcock used to pressure her to authorize the vaccine so the Biden administration could move forward with mandates. Gruber said, “They also made the point, as I state here in the email, that they feel that people have a tendency to get a vaccine that is authorized, but they may be hesitant and would be more likely to receive the vaccine if it would be licensed.”

Dr. Gruber also explained that the agency had data suggesting a risk of myocarditis, which requires a postmarketing study before the vaccines could be fully licensed. Gruber confirmed with Chairman Thomas Massie that Dr. Marks pressured her to “compress” this part of the timeline. When Gruber left her position in the FDA, Dr. Marks was appointed by Woodcock to replace her in this role.

When Massie asked Gruber if Dr. Marks and Woodcock had received instruction from outside the FDA to move up the timeline, Attorney Hilary LoCicero advised Gruber to not answer the question as it falls under the scope of a deliberative process within the FDA.

Alongside Marks’ resignation are 10,000 job cuts within HHS that were recently announced. Secretary Kennedy posted on X in response to the job cuts. He wrote, “This is a difficult moment for all of us at HHS. Our hearts go out to those who have lost their jobs. But the reality is clear: what we’ve been doing isn’t working. Despite spending $1.9 trillion in annual costs, Americans are getting sicker every year. In the past four years alone, the agency’s budget has grown by 38% — yet outcomes continue to decline. We must shift course. HHS needs to be recalibrated to emphasize prevention, not just sick care. These changes will not affect Medicare, Medicaid, or other essential health services. This overhaul is about realigning HHS with its core mission: to stop the chronic disease epidemic and Make America Healthy Again. It’s a win-win for taxpayers, and for every American we serve.”