Recent job cuts and regulatory changes at the US Food and Drug Administration (FDA) are delaying medical device approvals and raising fears of similar delays to drug approvals. If these delays persist, pharmaceutical companies may prioritise other markets or focus drug development outside the US, particularly since China has streamlined its approval process. Amid the flurry of staff changes at healthcare agencies, the Department of Health and Human Services (HHS) plans to lay off 10,000 people, at least eight senior Centers for Disease Control and Prevention (CDC) officials have resigned, and the US Senate has confirmed Mark Makary as FDA commissioner.
As a part of the Trump administration’s efforts for workforce optimisation, led by the Department of Government Efficiency (DOGE), the HHS announced on 27 March 2025 that it will cut 10,000 employees across the FDA, CDC and National Institutes of Health (NIH). To streamline and centralise administrative operations, the FDA will lay off 3,500 employees. These changes will not affect drug reviewers or inspectors, the HHS has stated. The Administration for Strategic Preparedness and Response (ASPR) will be moved under the CDC to better co-ordinate epidemic and outbreak responses, and the CDC workforce will be reduced by 2,400 employees. To consolidate procurement, human resources and communications across NIH, the agency plans to fire 1,200 employees.
Sacking younger employees may limit innovation
Mass dismissals began before the 27 March 2025 announcement. Over the weekend of 15 February, 1,000 FDA employees were fired. The following weekend, around 300 of those fired employees were asked to return. Some of those affected by the firing and rehiring were employees paid partially by user fees (payments by companies submitting drug or device applications, such as Prescription Drug User Fee Act [PDUFA] fees), probationary employees in their first one to two years of service, and employees who had recently moved into new positions. Thus, departments focusing on innovations such as AI have been greatly affected, since those employees have been recently hired to address new technologies.
Firing recent hires might also decrease the number of younger employees with more modern technical skills and fresh ideas. Targeting these groups could delay much-needed innovations that could help speed up the FDA’s review and approval process.
In addition to the FDA cuts, the Trump administration laid off CDC employees on 15 February – initially, this was planned to affect 1,300 probationary employees, which is one-tenth of the CDC’s workforce, but this number was reduced to between 700 and 750, according to the Associated Press. Two weeks later, the CDC rehired 180 of the fired workers. On 25 March, the heads of five departments left the CDC, following three other high-level resignations in previous weeks. In total, almost one-third of the CDC’s high-level officials have recently left.
The Trump administration also terminated 1,165 jobs at the NIH in mid-February, down from a planned 1,500, according to Reuters. Because the CDC and NIH typically work closely with pharma companies, laying off these experts and specialists could negatively affect research and development (R&D) for new products, delaying innovation.
On top of this, US House Republicans have suggested reducing the CDC’s budget by 20% and solely funding infectious disease work to prepare for the next pandemic. This could cost lives and damage the economy by diverting focus from opioid abuse, maternal health, mental health, cancer screenings and smoking cessation. It is not clear which proposals to restructure the CDC will be implemented, as other Republican lawmakers in Congress have voiced support for the CDC’s non-infectious disease programmes.
In terms of other cuts to HHS organizations, head of the Advanced Research Projects Agency for Health (ARPA-H) Renee Wegrzyn was fired by the Trump administration on 14 February. ARPA-H fast-tracks medical discoveries that are not typically funded by traditional sources or companies. This cut could affect R&D funding for manufacturing technologies that can lower costs, streamline production and mitigate supply chain risk by predicting demand, optimising inventory levels and identifying potential problems.
Makary confirmed as FDA head
On 25 March, the Senate voted to appoint Mark Makary, who plans to review the FDA layoffs led by the Trump administration, as FDA commissioner. According to Endpoint News, Makary is “a big believer that we need to figure out a way to get [drugs] approved quicker without cutting corners in the scientific review.” The nomination of Makary, a professor of surgery and public health, has stirred up some controversy among pharmaceutical leaders, as it is thought he may lack the expertise to be an efficient leader of the FDA. However, some in the industry are relieved that he is a medical professional who advocates for evidence-based healthcare, unlike some of Trump’s other divisive agency picks, of whose nominations the words ‘like throwing a match into a powder keg’ have been used. The Senate also confirmed Jay Bhattacharya as head of NIH.
Less than an hour before his Senate hearing, the Trump administration withdrew its nomination of David Weldon to lead the CDC, due to not having enough Republican support for his confirmation. On 24 March, the White House nominated Susan Monarez, the current acting director for the CDC, to become its permanent director. With a background in infectious disease research and biosecurity from her role as deputy director of ARPA-H, Monarez’s nomination has raised some concerns amongst CDC employees, since she has not been highly visible as a leader at the agency.
The push for reducing funding and the workforce at the FDA comes partly from US Secretary of Health and Human Services Robert F Kennedy Jr, who wishes to end industry user fees, which support almost half of the FDA’s $7.2 billion budget for the fiscal year 2025. The FDA User Fee Reauthorization Act is renewed once every five years, and the current deal expires in 2027. A reduction in PDUFA fees, and their generic counterparts, GDUFA, would reduce available funds for reviewers’ salaries. With the changes in the NIH, Kennedy also hopes to redirect its research focus to more holistic approaches to health.
DEI and recruitment
Another change within the FDA that could affect clinical supply chains is the targeting of diversity, equity and inclusion (DEI) initiatives. At the beginning of 2025, the FDA removed from its website a draft guidance on improving diversity in patient recruitment for clinical trials. The document related to the 2022 Food and Drug Omnibus Reform Act (FDORA) passed under the Biden administration, which requires sponsors to submit a diversity action plan for each Phase 3 clinical trial of a new drug. The clash between FDORA and the policies of US President Donald Trump, which limit or forbid federal funding for private companies with DEI initiatives, leaves pharma companies in uncertainty. “The implications of this action [the FDA’s removal of the draft guidance] are not yet known,” stated the pharmaceutical company Verve Therapeutics (Boston, MA) in its annual report filed to the Securities and Exchange Commission in February 2025.
