Peter Marks, the US FDA’s top official for vaccines and cell and gene therapies, has resigned. A survivor of the first Trump administration, when his office faced intense pressure to fast-track COVID vaccine approvals, Marks reportedly clashed with new Health and Human Services Secretary Robert F. Kennedy Jr. and his anti-vaccine stance. His departure has sparked concern across the pharma industry and comes amid broader upheaval in the nation’s health agencies. With more than 10,000 job cuts looming, the FDA’s role as the world’s gold-standard regulator and the US’s position as the first market for innovative therapies appear more fragile than ever.
Head-to-Head with Vaccine Skepticism
In an exclusive PhamaBoardroom interview in 2020, Peter Marks stressed the need to “follow the science.” This maxim seems particularly fitting after the director of the FDA’s Center for Biologics Evaluation and Research (CBER) quit under pressure, his views clearly in opposition to the new health secretary under the Trump administration, Robert F. Kennedy Jr. In his resignation statement, Marks protested to the United States’ current “unprecedented assault on scientific truth” and pointed out that Kennedy is actively encouraging misinformation about FDA-approved vaccines.
The agency veteran has played an important role in the safety evaluations and approvals of vaccines, as well as biologics such as cell and gene therapies. As head of the CBER, where he started in 2016, Marks took part in the creation of Operation Warp Speed, under which the federal government worked with the biopharma industry to step up the development of COVID-19 vaccines. Marks also gained notoriety and has been depicted as “industry friendly” due to his support for the agency’s accelerated approval pathway for rare diseases.
Trump’s health secretary Kennedy, sworn in in February, is known for his vaccine skepticism. In reaction to an ongoing measles outbreak in the US, he has downplayed the value of vaccines and promoted the use of vitamin A to fight the disease. In his letter, Marks mentioned the deadly toll of measles in view of the health secretary’s only half-hearted advice on the need for immunization.
Part of a Bigger Shakeup
Marks’ exit is the latest in a string of high-level departures from the agency, including Center for Drug Evaluation and Research (CDER) director Patrizia Cavazzoni and Chief Counsel Hilary Perkins, who have both departed from the FDA this year.
Recently confirmed incoming FDA commissioner Marty Makary is taking the reins of an agency that is also reeling from the cuts imposed by Elon Musk’s Department of Government Efficiency (DOGE), the removal of over 1,000 probationary workers in February, and efforts to rehire some of them.
And the upheaval within the agency is not over yet. Kennedy has announced the elimination of 10,000 jobs within the nation’s health agencies, including the FDA, from which 3,500 positions will be cut. These mass firings as well as forced resignations and reassignments have apparently already begun.
Falling Share Prices and Concern over Instability
As the measles outbreak persists in Texas and other US states, many experts are uneasy about the direction public health is taking under Kennedy. “Measles is a preventable disease. And really, the way to deal with a measles outbreak is to vaccinate people against measles,” said Adam Ratner, a member of the infectious disease committee of the American Academy of Pediatrics.
But beyond the debate around the use of vaccines, some see Marks’ exit from one of the world’s most respected regulatory agencies as a red light for science and evidence-based decision making as a whole. According to former FDA Commissioner Robert Califf, the matters Marks identifies “should be frightening to anyone committed to the importance of evidence to guide policies and patient decisions.” Califf further stated that he hoped the current situation would “intensify the communication across academia, industry and government to bolster the importance of science and evidence.”
The market is also reflecting the news. Shares of vaccine and gene therapy makers like Pfizer and Moderna have taken a blow, as worry within the biopharma industry grows. “It’s no secret that biotech has been under immense pressure recently, this unfortunate update does nothing to reassure investors or provide relief,” said BMO Capital Markets analyst Evan Seigerman.
“We are deeply concerned that the loss of experienced leadership at the FDA will erode scientific standards and broadly impact the development of new, transformative therapies to fight diseases for the American people,” said the Biotechnology Innovation Organization’s (BIO) chief executive John Crowley.
In a statement issued by the Alliance for Regenerative Medicine (ARM), the cell and gene therapy advocacy group expressed its concern about the risk of not maintaining the regulatory progress achieved in recent years. “We strongly encourage leaders to build on recent reform and modernization efforts.”
The lack of stability within the country’s health authorities adds to other causes for alarm for the life sciences sector such as Trump’s extreme tariff hikes that may affect supply chains and prices.
“There is a lot of noise coming out of the US,” said Marks at the height of the pandemic when anti-vax attitudes took hold in the country. “But when it comes to the FDA, it is patently clear that we are here to follow science to bring benefit to this country and, when possible, to bring benefit to the entire globe. That is only going to happen if we continue to dedicate ourselves to objectively working through the evidence.”
Echoing these sentiments in his resignation statement, he wrote: “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.”
