Ouster of Peter Marks & Mass FDA Layoffs Have Biotech Sector Bracing for Regulatory Disruptions
Thousands of FDA workers lost their jobs this week. The most prominent was Peter Marks, director of the agency’s Center for Biologics Evaluation and Research (CBER). While this position has been described as the FDA’s top vaccine official, it became much more under Marks.
Marks was appointed leader of CBER in 2016 and his tenure came alongside the emergence of new therapeutic modalities, such as cell and gene therapies. To some, he was a champion of new ways to treat diseases, particularly rare ones. In a note sent to investors after Marks’s resignation, Leerink Partners described him as a strong advocate of scientifically proven vaccines and treatments to prevent and cure disease. The loss of Marks could affect the ability of companies to get reliable regulatory guidance for the development of novel biologic medicines.
“We note that emerging therapeutic modalities — and especially cell & gene therapies — are particularly exposed to FDA disruption risks, given the need for support of science-based novel product development, and their inclusion under CBER authority,” the Leerink analysts said.
Under Marks’s tenure, the FDA exercised a “regulatory flexibility” that invited some criticism. Flexibility was cited in the 2022 approval of Relyvrio, an Amylyx Pharmaceuticals drug for amyotrophic lateral sclerosis that only had Phase 2 data, and in Elevidys, a Sarepta Therapeutics gene therapy for Duchenne muscular dystrophy that failed its Phase 3 test.
To the extent most Americans know of Marks, it might be his role as one of the top officials on Operation Warp Speed, the government initiative to collaborate with industry on the development of Covid-19 vaccines. Marks’s resignation letter offers a staunch defense of vaccines broadly, delivering a jab at Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, who has a long history as a vaccine skeptic. Marks said, “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.”
Here’s a rundown of key FDA developments of the past week along with some upcoming events to watch for:
Tuesday, March 25: The Senate confirms Martin Makary to be commissioner of the FDA, succeeding Robert Califf. The vote was 56 to 44.
Thursday, March 27: The Department of Health and Human Services announced a restructuring aimed at saving $1.8 billion annually. Some of the savings will come from job cuts. The department said its 82,000 workforce will be slashed by 20,000 full-time employees.
HHS is comprised of 28 divisions. The Trump administration said many of them are redundant. A new HHS structure will consolidate the department into 15 divisions. The combination of five agencies will lead to the creation of a new one, the Administration for Healthy America. HHS’s 10 regional offices will be cut down to five. HHS also announced job cuts to agencies under its umbrella. The FDA will downsize by 3,500 employees, “with a focus on streamlining operations and centralizing administrative functions,” HHS said. “This reduction will not affect drug, medical device, or food reviewers, nor will it impact inspectors.”
While the stated goals of the HHS reorganization are efficiency and taxpayer savings, some of the cuts positions are funded by fees paid by industry, so cutting them does not save taxpayers any money, STAT News reported.
Friday, March 28: Makary was sworn in as the new FDA commissioner and was briefed on the plan to push out the CBER leader, multiple sources told The Pink Sheet. The timing is important because it means Makary could have stopped the Marks ouster but did not. It was a private swearing-in, Politico reported. While the decision to remove Marks was Kennedy’s, he did so with Makary’s consent, sources told Politico.
Marks apparently was unaware Makary had taken over. His March 28 resignation letter was addressed to Sara Brenner, the acting commissioner. The letter noted that inoculation and vaccination reduced morbidity and mortality throughout American history, going back as far as the American Revolutionary War. Marks also said the undermining of well-established vaccines “is irresponsible, detrimental to public health, and a clear danger to our nation’s health, safety, and security.” Marks said his resignation will be effective April 5.
Saturday, March 29: News of Marks’ ouster starts rippling across the biotech industry. The Biotechnology Innovation Organization (BIO), released a statement from President and CEO John Crowley, who voiced concern that losing experience and scientific rigor at the top of the agency “will erode scientific standards and broadly impact the development of new, transformative therapies to fight diseases for the American people.”
Monday, March 31: In a note sent to investors, analysts at William Blair said the departure of Marks creates a significant near-term overhang for small and mid-cap biotech companies, particularly those in vaccines, gene therapy and gene editing, and cell therapy. While it’s unclear who will succeed Marks, the firm added there is “clearly a risk that the candidate’s views will be in line with Secretary Kennedy on vaccines.”
Senators Patty Murray of Washington, Rosa DeLauro of Connecticut, and Tammy Baldwin of Wisconsin, sent Kennedy a March 31 letter condemning the restructuring plans. “The stunning lack of transparency surrounding these changes leaves us deeply concerned about what the administration is hiding,” they wrote. “Moreover, several actions taken or proposed by the Administration appear to violate federal law.”
Tuesday, April 1: Emailed layoff notifications start reaching inboxes of thousands of federal workers overnight and early in the morning. Some employees did not realize they were let go until they found out they could no longer gain entrance to FDA offices. The job losses were not limited to the rank and file. Key agency leaders were also pushed out. Peter Stein, director of the Center for Drug Evaluation and Research’s Office of New Drugs, told STAT News he quit after being offered an alternate position. Former FDA Commissioner Robert Califf lamented the cuts in an April 1 LinkedIn post.
“The FDA as we’ve known it is finished, with most of the leaders with institutional knowledge and a deep understanding of product development and safety no longer employed,” Califf wrote. “I believe that history will see this a huge mistake. I will be glad if I’m proven wrong, but even then there is no good reason to treat people this way. It will be interesting to hear from the new leadership how they plan to put ‘Humpty Dumpty’ back together again.”
What’s Next?
April 10: The HHS reorganization has prompted a hearing before the Senate Committee on Health, Education, Labor and Pensions. Sen. Bill Cassidy, chairman of the committee, and Sen. Bernie Sanders, ranking member, sent Kennedy a letter asking him to testify in a hearing scheduled for April 10. The April 1 letter noted that during his confirmation hearings, Kennedy committed to appear before the committee to provide updates each quarter.
April 15 and 16: The CDC Advisory Committee on Immunization Practices (ACIP) will meet. This meeting was originally scheduled for February, but was cancelled after Kennedy assumed leadership of HHS. The department said the meeting was postponed to accommodate public comment in advance. Industry will be paying attention to the rescheduled meeting for signs of how vaccines will be handled under Kennedy’s leadership. The agenda includes Jynneos’s mpox vaccine, Moderna’s Covid-19 vaccine, respiratory syncytial virus vaccines from GSK and Moderna, and AstraZeneca’s nasal spray influenza vaccine FluMist.
Photo: Getty Images, Sarah Silbiger
