RA/QA News Roll: Late March 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
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This is our biweekly recap of news and industry happenings curated for our paid subscribers. Our goal is to bring you the headline news and the stories, research, and insights that might be harder to find.
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Here are some key items from the past couple of weeks.
💊 = Pharma, biologic, and biotech.
💉 = Medical device, medtech, diagnostics, and digital health.
Mass Firings at FDA 🚨
According to a breaking report in Endpoints News, the FDA is undergoing an unprecedented internal shakeup, with mass firings and forced resignations carried out on Tuesday as part of a larger wave of federal health agency job cuts initiated by the Trump administration.
The report by senior editor Zachary Brennan details chaotic scenes at the FDA’s White Oak campus, where some employees discovered they had been terminated only when their security badges failed to work. Several witnesses told Endpoints that staff were then escorted by security to collect their belongings.
One of the most notable figures affected, Peter Stein, director of the FDA’s Office of New Drugs, told Endpoints he was offered a sudden reassignment to “patient affairs” or termination. Calling the offer “ridiculous,” Stein chose administrative leave instead.
The layoffs are part of a broader plan announced by HHS Secretary Robert F. Kennedy Jr. to cut 3,500 positions — about 19% of the FDA's workforce — with the stated aim of “streamlining” the department for greater efficiency. However, the Endpoints report suggests the cuts are already causing significant disruption, particularly with the loss of experienced leaders in key areas like biologics and cancer drug review.
Earlier this week, Endpoints also reported that Peter Marks, who led the FDA’s Center for Biologics Evaluation and Research and played a critical role in vaccine regulation, had been pushed out. (More on this below.)
Former FDA Commissioner Robert Califf, now a vocal critic of the administration’s efforts, said on LinkedIn this morning, “The FDA as we’ve known it is finished,” expressing deep concern over the impact of these changes.
In addition to individual terminations, entire offices — including the Office of Media Affairs and Office of Communications — have reportedly been gutted. Efforts by Endpoints to contact the FDA for comment were unsuccessful, as many communications staff were among those fired.
The article notes that similar terminations occurred across other federal health agencies, with some senior officials being given the option to relocate to remote locations such as Alaska or Indian Health Services outposts.
Politico’s AgencyIQ cited FDA sources offering deeper insight into today’s cuts in the affected areas of the agency:
CBER has had its leadership gutted. Director Peter Marks resigned in protest after being pressured by HHS Secretary Robert F. Kennedy Jr. and new FDA Commissioner Marty Makary. His replacement, Julie Tierney, has already been placed on administrative leave. Other key leaders were also let go.
CDER’s top drug regulator, Peter Stein, resigned after being offered a demotion. The Office of Medical Policy was largely dismantled.
CDRH has seen over 200 staff affected. Key policy officials and offices like the Division of Industry and Consumer Education, Office of Management, and Office of Women’s Health were eliminated.
Most staff involved in negotiating critical industry user fees (PDUFA, MDUFA) have been laid off, casting doubt on upcoming negotiations.
OCE has been largely unaffected due to its focus on medical product reviews, though two senior leaders have departed.
The entire Office of Media Affairs has been disbanded, disrupting the FDA’s communication with the press and public.
Peter Marks Resigns 🚨
Dr. Peter Marks, the longtime head of the FDA’s Center for Biologics Evaluation and Research, has resigned amid growing tensions with Health and Human Services Secretary Robert F. Kennedy Jr. In his resignation letter, Marks condemned Kennedy for promoting vaccine misinformation and accused him of seeking only “subservient confirmation” of falsehoods rather than engaging in honest scientific dialogue. Marks, who has served as a central figure in vaccine regulation since 2016, said Kennedy’s actions threaten the integrity of public health policy and undermine trust in life-saving vaccines.
Throughout his tenure, Marks was instrumental in guiding the U.S. through the COVID-19 pandemic, leading the FDA’s efforts to authorize the Pfizer-BioNTech and Moderna vaccines under Operation Warp Speed. He expressed a willingness to work with Kennedy on issues of vaccine safety and transparency, but ultimately concluded that the administration’s priorities were not aligned with scientific truth. His departure comes as Kennedy continues to make controversial claims about vaccines, including calling the COVID-19 vaccine the “deadliest ever made” and suggesting that the MMR vaccine causes deaths annually — statements refuted by major medical organizations.
Marks’ resignation highlights the growing concern among health experts about the impact of vaccine misinformation on public health. He pointed to the current measles outbreak, particularly severe in Texas, as a consequence of eroding public trust in vaccines — a disease once eliminated in the U.S. that has now resurged. Citing the deaths of over 100,000 unvaccinated children globally due to measles complications, Marks warned that the rejection of established science puts countless lives at risk. His exit signals a deepening rift between career scientists and political appointees within the federal health system.
News of Marks’ resignation from the FDA had a significant impact on the biotech market Monday, with Reuters reporting that the SPDR S&P Biotech ETF closed down 3.9% following the announcement. In response, analysts at Cantor Fitzgerald — the firm formerly led by current Secretary of Commerce Howard Lutnick — issued a public statement calling for HHS Secretary Robert F. Kennedy Jr. to resign, referring to him as an “anti-vax, conspiracy theorist with inadequate training.”
FDA and the New Administration
HHS Secretary Robert F. Kennedy Jr. announced that the department will be terminating approximately 10,000 full-time employees, including 3,500 staff from the FDA — about 18% of the agency's workforce. While some HHS agencies will be consolidated into new entities, the FDA is expected to remain intact. The cuts will largely exempt FDA reviewers and inspectors, focusing instead on administrative personnel and staff in IT, human resources, procurement, external affairs, and policy. In a statement on the social media platform X, Secretary Kennedy acknowledged the cuts would result in a “painful period” for HHS staff but described them as necessary to “do more with less.” He also criticized certain FDA personnel for obstructing his office’s access to adverse event data, stating, “In one case, defiant bureaucrats impeded the secretary’s office from accessing the closely guarded databases that might reveal the dangers of certain drugs and medical interventions.” Additional details are included in an HHS fact sheet.
The U.S. Senate voted 56–44 to confirm Marty Makary as commissioner of the FDA. Makary is expected to join the agency today as Commissioner of Food and Drugs. He was sworn in today.
The top leadership of the FDA’s CBER has been significantly reduced in recent days. CBER Director Peter Marks resigned on Friday in protest after being forced out by HHS Secretary Robert F. Kennedy Jr., with the support of newly confirmed FDA Commissioner Marty Makary. Following Marks’ departure, Julie Tierney was appointed acting director, but a senior source confirmed that as of this morning, she has been placed on administrative leave. Additional CBER leaders, including James Myers, associate director for policy, and Chris Joneckis, director of the Office of Regulatory Operations and a key negotiator on the Prescription Drug User Fee Amendments, are also affected by the reduction in force (RIF).
An executive order signed by President Trump would prohibit collective organizing by FDA staff and employees of other government agencies, citing their roles as essential to national security. A memo from the Office of Personnel Management states that the FDA should “cease the use of pre-decisional involvement of labor unions and employees in agency matters,” and should provide a projected timeline by April 30 to dismantle all labor-management forums, committees, and councils. Reports from FDA staff indicate that labor representatives from the National Treasury Employees Union, which represents FDA staff through Chapter 282, have been informed they no longer represent FDA employees.
Coinciding with the dissolution of the FDA’s union, the Office of Personnel Management has issued a memo outlining changes to performance assessment procedures that would make it easier for the FDA to terminate employees deemed underperforming. Performance Improvement Plans, previously lasting up to 120 days, are now limited to 30 days. In certain cases, staff may also face immediate termination.
The Federal News Network reports that some HHS employees who accepted a voluntary buyout valued at up to $25,000 and eight weeks of leave believe they were misled about the terms of the agreement. HHS is requiring these employees to separate by May 9, which would result in them receiving between three and six weeks of administrative leave, rather than the full eight weeks.
The Washington Post reported that HHS Secretary Robert F. Kennedy Jr. has appointed David Geier to lead a study examining potential links between vaccination and autism. Geier, described by the Post as a “vaccine skeptic who has long promoted false claims about the connection between immunizations and autism,” has co-authored papers with his father, Mark Geier, asserting that vaccines increase the risk of autism — a theory that has been extensively studied and scientifically discredited.
As numerous FDA staff involved in negotiating the Over-the-Counter Monograph Drug User Fee program (OMUFA) were being terminated from the agency, the House Energy and Commerce Committee’s Health Subcommittee convened a hearing to discuss the reauthorization of the OMUFA I program. The timing prompted pointed remarks from some lawmakers. “While we are sitting here having this hearing, our premier research institutions, which are the gem of the entire world, are being dismantled before our very eyes, and we are just sitting here talking about sunscreen,” said Rep. Diana DeGette (D-Colo.) at the start of the hearing.
FDA General
New reporting by Reuters reveals that, as many in industry have feared would happen, FDA layoffs are already slowing the review of medical products. According to the report, some staff have been instructed to double their workload related to new product applications and to defer other responsibilities, including oversight of fellow reviewers and the provision of early feedback on planned product submissions. Additional staff reductions announced today are expected to further impact the review process, as policy experts and legal counsel — who help ensure the consistency of reviews — are among those affected.
A federal court in Texas yesterday struck down the FDA’s final rule on Laboratory Developed Tests (LDTs), dealing a significant blow to the agency’s longstanding effort to regulate LDTs under the same framework used for other diagnostics. The court remanded the regulation to HHS Secretary Robert F. Kennedy Jr., who is expected to withdraw the rule. 💉
Paul Kluetz and Marc Theoret, both deputy center directors at the FDA’s Oncology Center of Excellence, plan to depart the agency soon. Their exit marks a significant loss for the FDA’s oncology drug division and leaves Rick Pazdur, the center’s director, without his longtime deputies who played key roles in shaping oncology policy. Theoret, for instance, was closely involved in Project Optimus, the center’s dose optimization initiative. It remains unclear whether their departures signal that the Oncology Center of Excellence could be significantly affected by upcoming layoffs. 💊
The FDA has published the fiscal year 2025 facility fee amounts under the Over-the-Counter Monograph User Fee Program (OMUFA), reflecting a nearly 10% increase over the 2024 rates. Since the program’s inception, facility fees have nearly doubled — an important development in the context of the ongoing OMUFA reauthorization process.💊
The FDA has scheduled a joint meeting of its Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee for May 5. The committees will review data from two completed studies on extended-release and long-acting opioids, focusing on the risks of misuse, abuse, addiction, and overdose. The meeting was originally planned for February and marks a resumption of advisory committee scheduling. 💊
The FDA today released an updated technical specifications document, Version 6.0, to support companies utilizing specific submission standards. This is the first update since October 2024 and primarily includes language revisions to several standards. 💊
The FDA has released a series of new videos aimed at explaining the challenges involved in rare disease drug development. The videos cover topics such as regulatory considerations for designing rare disease clinical trials, the selection of endpoints in rare disease drug development, the use of natural history data, and other related subjects. 💊
Hilary Perkins, the FDA’s most recent chief counsel, resigned from her position just two days after her appointment following concerns raised by Sen. Josh Hawley (R-Mo.) regarding her past involvement in the FDA’s actions on mifepristone. Perkins has now published an op-ed in The Wall Street Journal disputing Hawley’s claims and detailing how she was asked to serve as chief counsel by incoming FDA Commissioner Marty Makary. In the piece, Perkins describes efforts to defend her reputation and suggests she may seek reinstatement. She previously addressed the matter in interviews with The New York Times. “Instead of pushing out a ‘Biden abortion lawyer,’ he forced out an experienced conservative pro-life attorney who supports the Trump administration,” she wrote. “Nothing I did as a career attorney negates who I am or what I believe. I simply followed my oath to defend the legality of the government’s actions.”
The FDA has launched a new webpage dedicated to pulse oximeters, a medical device that has previously raised regulatory concerns over potential inaccuracies in readings for individuals with darker skin pigmentation. The release of the webpage follows the close of the public comment period on the FDA’s draft guidance for pulse oximeters, which ended on March 10. 💉
The FDA has issued an update to its data submissions standards catalog, which lists standards recognized by the Center for Biologics Evaluation and Research, the Center for Drug Evaluation and Research, the Center for Devices and Radiological Health, and other FDA centers. According to the change log, the updates are primarily editorial, with a few clarifications related to the support start dates for two Study Data Tabulation Model (SDTM) standards and the requirement start dates for two additional SDTM standards. 💊
The Association for the Advancement of Medical Instrumentation (AAMI) announced that the FDA has recognized one of its key new sterilization standards, AAMI TIR106:2024: Microbiological methods – Understanding and use of product bioburden data. In addition, the FDA has recognized updated versions of three other sterilization standards. 💊
The FDA’s Electronic Submission Gateway (ESG) NextGen is set to launch on April 14. In preparation, the agency has released two new guides that provide detailed information on how the updated system operates. One guide focuses on ESG NextGen’s application programming interface (API), which enables companies to develop tools for submitting regulatory information to the FDA. The second guide covers the Applicability Statement 2 (AS2), a protocol that also facilitates easier submission of information to the ESG.
The House Oversight and Investigations Subcommittee of the Energy and Commerce Committee held a hearing today focused on cybersecurity vulnerabilities in legacy medical devices. In a joint statement, Committee Chair Brett Guthrie (R-Ky.) and Subcommittee Chair Gary Palmer (R-Ala.) emphasized the importance of addressing cyber threats, stating, “It is imperative we defend against cyber threats to protect patients and safeguard our national security.” The hearing will examine concerns related to vulnerabilities in legacy medical devices, their potential impact on patient safety and healthcare operations, and strategies to improve cyber resilience. 💉
Governing
Republican lawmakers are seeking to limit the ability of federal judges to issue nationwide injunctions against the federal government, citing FDA-related cases as part of their justification. A fact sheet from the Senate Committee on the Judiciary highlights a 2023 case in which a district judge in Texas suspended FDA approval of the abortion drug mifepristone nationwide. The proposed changes are part of the Judicial Relief Clarification Act, introduced today by Committee Chair Chuck Grassley (R-Iowa). According to Grassley, the legislation would require parties seeking nationwide relief to file a class action lawsuit. It would also amend the Administrative Procedure Act and the Declaratory Judgment Act to restrict courts' decisions to the parties before them and make temporary restraining orders (TROs) immediately appealable.
Rep. Ted Lieu (D-Calif.) has reintroduced the DEVICE Act, legislation that would require medical device manufacturers to provide written notice to the FDA regarding any changes to device reprocessing instructions. The bill was also introduced during the previous session of Congress. 💉