RA/QA News Roll: Mid March 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
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.
FDA and the New Administration
The Trump administration is preparing to significantly reduce the workforce of the Department of HHS, according to a report by POLITICO. An official announcement regarding the cuts is expected soon. The reported workforce reductions are expected to affect agencies across the department. Despite a deadline to submit its reduction plan to the White House by last week, HHS has not yet publicly disclosed its strategy for implementing these cuts.
Marty Makary, President Donald Trump’s nominee for FDA commissioner, has cleared a key hurdle in the confirmation process. The Senate Health, Education, Labor, and Pensions Committee approved his nomination in a 14-9 vote, with two Democrats joining Republicans in support. A notable development in the process involved Sen. Josh Hawley (R-Mo.), who had reportedly been prepared to withhold his vote unless the FDA’s chief counsel, Hilary Perkins, resigned. Perkins stepped down early Thursday morning, effective immediately, resolving Hawley’s concerns. Makary’s nomination now moves to the full Senate for a final confirmation vote. However, with the Senate in recess all next week, the vote will not take place immediately.
U.S. District Judge James Bredar has ordered the Trump administration to reinstate workers who were fired from 18 federal agencies, including the Department of Health and Human Services, which oversees the FDA. According to POLITICO reporters Kyle Cheney and Josh Gerstein, the judge determined that the administration used “false allegations of ‘performance’ issues as a pretext to justify the large-scale firings and ignore legally mandated procedures for slimming the workforce.” In response, former President Donald Trump has asked the Supreme Court to restrict judges' authority to issue nationwide injunctions or restraining orders in such cases.
A new Office of Personnel Management (OPM) memo recommends that all federal agencies, including the FDA, reclassify their chief human capital officer (CHCO) positions from "career reserved Senior Executive Service (SES)" to "SES general." This change would allow for greater flexibility in appointing individuals aligned with the administration’s political and policy priorities to agency HR leadership roles. A search of the FDA’s website does not show a position titled CHCO, though the agency does employ Tania Tse as director of the Office of Human Capital Management, a role that may function similarly.
FDA General
Doug Kelly, deputy center director for science at the FDA’s CDRH, announced his departure from the agency. Kelly, who joined CDRH during the pandemic, played a key role in recruiting many of the center’s senior leaders.Kelly was one of three deputy center directors reporting to CDRH Director Michelle Tarver. Finding a replacement from outside the FDA may prove challenging, given the specialized expertise required for the role. 💉
The FDA has updated its Learning and Education to ADvance and Empower Rare Disease Drug Developers (LEADER 3D) program webpage to include two new case studies on rare disease drug approvals. The case studies highlight Xepozyme and Nulibry, two drugs that followed different approval pathways. Nulibry was approved as a treatment for molybdenum cofactor deficiency type A using a single adequate and well-controlled clinical trial combined with confirmatory evidence. Xepozyme, approved for acid sphingomyelinase deficiency, utilized a clinical dose-escalation strategy to support its application. The FDA typically presents such information in Summary Basis of Approval documents, which focus on individual applications. By publishing these case studies, the agency aims to share successful regulatory strategies used in rare disease drug development. According to the FDA, the new resources are designed to illustrate "approaches used by several sponsors when designing and conducting their rare disease drug development programs." 💊
The FDA canceled its externally facing advisory committee meeting for recommending the next seasonal influenza vaccine, but the agency confirmed it held a closed-door meeting with government experts from the FDA, CDC, and Department of Defense to help determine the flu virus strains for the upcoming season. According to an FDA statement, the meeting included 10 FDA staff members, including Center for Biologics Evaluation and Research Director Peter Marks and top vaccine officials Jerry Weir and David Kaslow. The agency did not announce the meeting in advance or make it public, and no explanation has been provided for the lack of transparency. Following the meeting, the FDA recommended that seasonal flu vaccines contain two flu A strains and one flu B strain, with different strain selections for egg-based versus cell- or recombinant-based vaccines. The FDA has since posted the meeting agenda and presentation slides on its public website. The strains endorsed by the agency align with those recommended by the WHO. 💊
The CDRH maintains the electronic submissions template and resource (eSTAR), the required format for most medical device submissions. In February 2025, the agency released an update to eSTAR, incorporating new content on artificial intelligence and machine learning, updates to terminology to align with Trump administration executive orders, and information on future updates to the system. 💉
HHS announced that Hilary Perkins, a former Justice Department attorney, will become the FDA’s new top attorney. Meanwhile, Robert Foster, who joined the FDA as chief counsel earlier this month, will move into an elevated role at HHS as deputy general counsel and chief counsel for food, research, and drugs. His new position will oversee the FDA’s general counsel. The personnel changes come as HHS restructures its Office of the General Counsel, reducing its 10 regional offices to just four as part of a broader reorganization.
The Make America Healthy Again Commission, established by a recent executive order, held its first meeting, according to The New York Times. The closed-door session did not disclose its agenda or list of attendees.
The FDA has posted its first batch of updates to its executive calendar of public meetings since early January, providing the first public insight into the activities of Acting FDA Commissioner Sara Brenner. According to the newly released calendar, Brenner has not held any significant public events since assuming the role. The most active FDA executives in recent months have been CDRH Director Michelle Tarver and CBER Director Peter Marks. Tarver has met with several medical device companies, including Oura Ring, NexEos Bio, Perseus Strategies, Philips, Medtronic, Chemours, and the Medical Device Innovation Consortium. Meanwhile, Marks’ calendar reflects only a few public speaking engagements.
The FDA announced the appointment of Jim Traficant as its new chief of staff, marking a departure from past practice as he joins the agency without prior FDA experience. Traditionally, chiefs of staff have been hired from within the agency to leverage their familiarity with internal processes and personnel. Traficant replaces Elizabeth Jungman, who previously served as associate director for policy at CDER. Jungman remains listed under that title in CDER’s staff directory, suggesting she may return to that role.
The FDA has updated its guidance webpage outlining expectations for pharmaceutical compounders producing versions of GLP-1 drugs, including semaglutide and tirzepatide. Given the ongoing litigation surrounding this issue, the agency is expected to update the webpage frequently in the coming weeks. A key deadline approaches on March 19, when outsourcing facilities will be required to cease compounding tirzepatide in compliance with regulatory directives. 💊
Governing
Legislation known as the Increasing Transparency in Generic Drug Applications Act has been reintroduced in Congress. If passed, the bill would require the FDA to enhance transparency and information-sharing regarding the "sameness" of ingredients in prospective generic drugs compared to their reference products. The measure aims to improve clarity in the generic drug approval process and facilitate smoother regulatory review. 💊
The Biotechnology Innovation Organization (BIO) is advocating for legislators to reauthorize the Rare Pediatric Disease Priority Review Voucher (PRV) program as part of the Give Kids a Chance Act. The program provides priority review vouchers to companies developing treatments for rare pediatric diseases, incentivizing investment in therapies for conditions with limited treatment options. 💊