The Curious Case of FDA's Dr. Peter Marks

A case study in scientific bureaucrat incompetence and entitlement

Peter Principle (def, Wikipedia): The Peter principle is a concept in management developed by Laurence J. Peter which observes that people in a hierarchy tend to rise to "a level of respective incompetence": employees are promoted based on their success in previous jobs until they reach a level at which they are no longer competent, as skills in one job do not necessarily translate to another.

Why should you care about the curious case of Dr. Peter Marks, MD, PhD? The recently resigned head of the FDA Center for Biologics Evaluation and Research (CBER)? Because Dr. Peter Marks provides an excellent case study of what happens when the government settles for acceptable instead of excellent in scientific administrator (bureaucrat) positions.

It is hard to find experienced, top-tier minds to fill government jobs. The salary is about 2/3 or less of comparable positions in industry, particularly in the pharmaceutical industry. Hardly a good way to raise a family and buy that five-bed colonial in Alexandria, McClain, or Potomac that would clearly demonstrate to your associates how important you really are. The work is generally a mundane daily grind, with mounds of paperwork interspersed by various required personnel and management activities. Lots of risk if the administrator veers away from standardized processes. There is little opportunity for innovation or discovery. Great minds crave independence. This dynamic is amply illustrated by the huge raises typically enjoyed by almost all of those who leave the government to take positions in Pharma- even the intellectual hacks and wannabees.

What a senior job in government does provide is power and status. You make decisions that massively impact on regulated industry profit and policy. Everyone wants your attention for their pet project. The press fawns on you because of the forces that drive “access journalism.”

Those who can, do. Those who can’t, regulate.

I am reminded of two examples of widely repeated wisdom concerning academia. The first example is that those who actively seek to become Department Chairperson are usually seeking power over their peers, and are the ones that should be specifically avoided when selecting a Department Chair or Dean position. The second is that the reason academic politics are so nasty is that there is so little to fight over.

After his initial selection as Deputy Director CBER, Dr. Marks rapidly rose to prominence in the ranks of the FDA, and was rewarded with a plum high-status appointment to the National Academy of Science- not on the basis of his intellect, scientific achievements, mastery of regulatory science or technical excellence- but because he advocated for reduced regulation of the pharmaceutical industry where he had worked prior to his initial FDA appointment.

At that point, why did you decide to switch career paths?

It was a mix of personal and professional reasons, but a driving factor was that, during my time at Brigham and Women's, my spouse and I had two children and I wanted to have more family time.

So, I moved to a position in the pharmaceutical industry for a few years. It turned out to be a very productive period of my career: I was involved in the successful regulatory approval of the first oral iron chelator in the U.S. and helped to set the direction for the regulatory approval of two other products that are now on the market.

The work I did there to bring that drug to market was exciting, but the idealist in me wanted to get back to patient care and public health. So, I returned to academic medicine at Yale University. While I was there, I helped expand the adult leukemia service. Eventually, I served as the first chief clinical officer of the then-new Smilow Cancer Center.

After you returned to academic medicine, why did you decide to move to the public sector?

I enjoyed my job at Yale quite a bit, but during that time I happened to see an advertisement in the New England Journal of Medicine for the position of deputy director of the FDA's Center for Biologics Evaluation and Research (CBER). The job description seemed to match up nicely with my training and experience, so I applied. I didn't expect much to happen, and that's exactly what occurred. I got busy with other work and practically forgot that I had applied.

Then, several months later, I received a letter inviting me for an interview. That process went on for months, which ended with me being offered the position. I began as the deputy director of the CBER in January 2012 and took over as director at the beginning of 2016.

American Society for Hematology, Clinical News

“Pulling Back the Curtain: Peter Marks, MD, PhD”

Just to say, in the pharmaceutical industry “was involved in” and “helped set the direction for” are other ways of saying “I played a modest role in the team that did these things.” There is no evidence that he held a senior appointment during his time in industry, just as he seemed previously to be on a “clinical” track in his academic medicine appointments - rather underwhelming for a MD, PhD. He seems to have “met expectations” through this pre-FDA phase of his career, but certainly did not exceed expectations.

The ultimate expression of Dr. Marks’ lasses-faire regulatory philosophy was “Operation Warp Speed” (OWS), during which both the regulatory and bioethical framework for gene therapy and vaccine product regulation and clinical testing that had been developed over decades of international experience and consensus was metaphorically thrown in the trash can. All based on hype and flawed modeling indicating a 3.4 % case fatality rate (CFR) for SARS-CoV-2 infection, when the true CFR was akin to that of a more severe seasonal influenza outbreak- as demonstrated quite early in the outbreak by current NIH Director Jay Bhattacharya. OWS and the global harms incurred from the various gene therapy-based COVID vaccines that caused patients to produce high levels of the remarkably toxic “spike” protein for prolonged periods all flow directly from the regulatory philosophy and actions of Dr. Peter Marks.

Dr. Marks’ partner in this endeavor was then Assistant Secretary HHS for Pandemic Response (ASPR) Dr. Robert Kadlec, a notorious “deep state” operative with close historic ties to the company that markets the Anthrax vaccine (Emergent Biosolutions), the Defense Intelligence Agency, and Dick Cheney.

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 due to the unwavering commitment of public servants at FDA and elsewhere across the government. At 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. The vaccines undoubtedly markedly reduced morbidity and mortality from COVID-19 in the United States and elsewhere.

Dr. Peter Marks letter of resignation, March 28, 2025

As far as I am concerned, it is hard to make the case that President Donald Trump, whose core competencies are in real estate, business development, marketing, and media was responsible for OWS except for the fact that he was overly dependent on and insufficiently skeptical of the scientific administrators advising him - specifically including Drs. Peter Marks and Robert Kadlec.

Dr. Peter Marks, MD, PhD, decided to leave Federal employment after fourteen years at the FDA Center for Biologics Evaluation and Research (CBER), apparently in response to the Secretary of HHS indicating that he had the option of resigning voluntarily or being terminated for cause. Or so corporate press reports. At the time of his resignation, Dr. Marks had served the public as the Director of CBER since 2016 (three years prior to COVID), and before that had served as Deputy Director CBER from 2012-2016 (source).

As is standard HR practice in these types of personnel actions, the Secretary of HHS, Mr. Robert F. Kennedy Jr. (or his office), has declined to comment or verify that this is what transpired. Therefore, we have no information as to what the specific cause for termination would have been. What we do have is a copy of Dr. Marks’ FDA resignation letter dated 28 March (attached below) in which he states:

Over the past 13 years I have done my best to ensure that we efficiently and effectively applied the best available science to benefit public health. 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.

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 breadth of 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 and will do my best to continue to advance public health in the future.

In performing diligence for this essay, I wanted to understand Dr. Marks’ academic background, scientific achievements, and qualifications for running the dominant Western regulatory authority for biologics, vaccines, blood products, as well as cell and gene therapy, and so searched for information regarding key career milestones for Dr. Marks including his CV or Google Scholar listing (Google Scholar is a leading resource for evaluating academic contributions and standing). Nothing. Nada. Like his history has been wiped from the internet. He claims to be trained as a Ph.D. Molecular Biologist (why does this matter you ask? See below), but in searching the federal PubMed database I only find five unremarkable cell biology papers during his PhD training. He claims to be a public health expert, but I can find no evidence of formal training or experience in public health, clinical research, or regulatory affairs prior to his joining the FDA. In his academic career he rose to the level of “Instructor,” which is a remarkably modest rank for an MD. PhD. Basically, I can find no evidence of scientific excellence, leadership or remarkable achievements while investigating the scientific and clinical experience of Dr. Marks.

Why are Dr. Peter Marks’ scientific qualifications and experience important? Why am I focused on nitpicking these nuances? Four main reasons grounded in personal experience:

1. I met with him via zoom on June 03, 2021 to discuss the Pfizer Japanese regulatory submission documents that Dr. Byran Bridle had discovered on a Japanese regulatory affairs server. These documents clearly documented that Pfizer had failed to meet both FDA and worldwide regulatory norms with their non-clinical studies concerning the mRNA COVID vaccine, and yet FDA/CBER/Marks was proceeding with Emergency Use Authorization. My belief at the time was that FDA was acting in good faith, but lacked the specialized experience required to see through the misleading information that Pfizer had submitted (particularly regarding the biodistribution and toxicities of the injected product and resulting genetic transfer). In that meeting, which was also attended by an FDA PR representative, Dr. Marks indicated that he had seen additional data from Pfizer (what is now commonly referred to as the “Pfizer Papers”,) and that there was nothing there that “concerned” him. Furthermore, Dr. Marks asked me - as an expert in the area- to withhold public criticism until he could release the supporting data.

   This was a manipulative ruse and a lie, and I hate being lied to and manipulated. He had no intention of releasing the data to the public, which data eventually required court action for release. Were it not for this like and misdirection, I would have spoken out earlier and more forcefully, but I acted to withhold my criticism out of respect for what I believed was an honest colleague. Furthermore, I remain convinced that Dr. Peter Marks was not then and remains unqualified by training and background to understand the nature and flaws in the non-clinical data submitted by Pfizer in support of this product.

2. Dr. Peter Marks is inexperienced in the specialized domain of gene therapy technologies and products. His PhD may have been in “Molecular Biology”, but there is no indication that we was rigorously trained in modern Molecular Biology - which is one of my specialities. He is also neither experienced nor trained in vaccinology, nor in immunology. His ignorance in these areas became abundantly clear during the COVIDcrisis. This inexperience and ignorance, combined with his apparently average scientific acumen, played a key role in enabling the flawed global leadership of the FDA during the COVID crisis. It is important to understand that, during the COVID crisis, the USA and specifically the US FDA set the standards for global regulatory policy among all NATO, EU, UK-affiliated and five eyes intelligence network allies. The politicization of regulatory policy within all of these nation-states and super-national organizations flowed directly from the flawed analysis and insights of Dr. Peter Marks.

3. When confronted by objections to his analysis and decisions by his two top vaccine subject matter experts concerning authorization of the genetic vaccine “booster” shots (Drs. Philip Krause and Marion Gruber), Dr. Peter Marks overruled them. Apparently, due to his sense of ownership of OWS and a certain obstinance and oppositional defiance, which is reflected in comments made in his resignation letter.

Turning to a recent essay from “A Midwestern Doctor” which succinctly summarizes this turn of events:

One of the most important whistleblowers to come forward was Philip Krause, who had worked in the FDA for 30 years. This was because Krause along with his direct superior Marian Gruber, had been the most senior FDA officials in charge of America’s vaccines, and at the end of August 2021, in the middle of arguably the FDA’s most critical vaccine assessment in history, they abruptly resigned (which was a seismic enough event the mainstream media covered it and even mentioned it being due to political pressure from White House for the COVID boosters). Following this, Krause and Gruber published an article in the Lancet. Krause also published a series of editorials (e.g., this one, this one, this one in the Washington Post) arguing against the current booster program.

Following this, he testified in front of Congress about how the COVID vaccines were handled.

See the following for details of that testimony-

The entire March 02, 2025 substack essay titled “Why Did The FDA Greenlight The COVID Vaccines? Recent whistleblower testimonies have revealed the anatomy of corruption within the FDA” is directly relevant to this current discussion concerning the incompetence of Dr. Peter Marks.

Why Did The FDA Greenlight The COVID Vaccines?

4. Finally, there is the issue of the DNA fragment contamination and adulteration of virtually all of the current “mRNA”-based COVID gene therapy products. Why do I put “mRNA” in quotes? Because these products to not actually employ mRNA - as anyone well trained in molecular biology would readily recognize- but rather employ a heavily modified synthetic mRNA analog more properly referred to as “pseudo-mRNA”. It is this modification that changes short lived mRNA molecules into material that can be used to produce protein but is not actually mRNA- for which Kariko and Weissman were recognized by the Nobel Prize committee for making the COVID gene therapy technology-based vaccines possible. As Dr. Kevin McKernan and so many other actual molecular biologists all over the world have documented, the current manufacturing process used to produce these COVID gene therapy-based products yields material that is contaminated - adulterated- with levels of DNA fragments (and sequences) that are neither acceptable nor disclosed to patients and their physicians. Under normal circumstances and under unbiased regulatory oversight, this adulteration issue should have been discovered long before these products were administered to humans. Furthermore, upon discovery by McKernan and others, the FDA should have immediately launched an investigation and withdrawn these products from the market due to this adulteration. Instead, Dr. Peter Marks, in close coordination with vaccine industry academic apologist and FDA Vaccine advisory board member Dr. Paul Offit launched an absurd media campaign to deny that the delivery formulations used for the pseudo-mRNA would also deliver the contaminating DNA fragments into patient’s cells.

   This action was criminal, in my opinion, and should be both investigated and prosecuted to the extent supported by current federal law. Dr. Peter Marks was not pardoned by outgoing President Biden.

   For further details, please see the following substack essays:

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This history of Dr. Peter Marks and his actions during the COVID crisis illustrate the potential consequences of allowing bureaucrat-scientists to set public policy. Dr. Marks could have provided substantial and productive long term contributions at the FDA. But he was never suited for the position of Director of CBER. He lacked the experience, training, intellect and temperament for the job. Throughout his career, he repeatedly failed upward, providing a classic example of the ironically named “Peter Principle”. Towards the end of his career as a public servant, he ran out of the FDA two highly qualified and experienced vaccine regulatory experts, both of whom have acted with integrity since that notable decision to leave - in particular Dr. Philip Krause.

Yes, the history of Dr. Peter Marks provides an excellent case study of what happens when the government settles for acceptable instead of excellent in scientific administrator (bureaucrat) positions. But beyond that, this particular example also illustrates a problem that has underpins the incompetency and chronic failure of the entire HHS enterprise to fulfill its primary mission- to protect and improve the health of American citizens. To repurpose and realign the HHS enterprise and bureaucratic infrastructure with the task of Making America Healthy Again will require aggressive reorganization and job cuts to eliminate redundant personnel and eliminate those who have been promoted to "a level of respective incompetence." This will disrupt families, cause personal trauma, and some of the good ones will unnecessarily be “made redundant”. This is the nature of organizational restructuring. The general guidance during this type of restructuring is that you should cut more deeply than you really need to, and then immediately begin hiring that aligns more closely to the new priorities and structure.

This is how you run a large business enterprise, and this is what needs doing at HHS. So spare me the tears and the angry backlash of privileged scientist-administrators like Dr. Marks and his ilk. He can take this as an opportunity to re-evaluate his actions, or he can just become another Pharma shill and double his salary. All of this reminds me of the curious case of Dr. Rick Bright - formerly Director of BARDA, who jumped to a nice position with the Rockefeller after departing HHS in a huff because he was reassigned to solve the problem of faulty COVID testing.

But for the rest of us, we have been damaged by the actions and inactions of Dr. Peter Marks. Global regulatory science, clinical research, and medical ethics have been damaged by his actions. And his emotional outbursts, attacks and defamation of the Secretary of HHS together with his whining self importance puts me in no mood to forgive these crimes against humanity and my profession.

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