This Week: Federal workforce cuts, Trump buyout offer delayed, and FDA’s RTO

Correction: A previous version of this article stated that FDA staff were told to return on 17 February and not 17 March.

Welcome to another installment of This Week at FDA, your weekly source for updates—big and small—on FDA, drug, and medical device regulation and what we’re reading from around the web. This week, multiple sources reported that the White House is preparing to make significant staff cuts at federal health agencies, the deadline for President Trump’s federal worker buyout was pushed back by a federal judge, and FDA staff were told to return to the office starting later this month.

The Washington Post reported this week that HHS leaders have been told to rank their employees who are in probationary periods to determine which employees are more essential. According to sources, managers are bracing for staff layoffs by employees considered less essential.

The Wall Street Journal also reported that the Trump administration is preparing an executive order to fire thousands of workers at the US Department of Health and Human Services (HHS). The sources say the administration plans to order agencies such as FDA to cut a certain percentage of their workforce and could be issued as soon as next week.

A White House source told Focus, "There is no EO being drafted or prepared to this effect. Neither [the Department of Government Efficiency (DOGE)] nor [the Office of Personnel Management (OPM)] are working on anything similar, either."

As the Trump administration looks to cut the size of FDA, current and former agency officials say the downsizing may cause it to miss prescription drug user fee act (PDUFA) goals, according to BioCentury.

The president has also said his administration will end work-from-home policies and will order federal workers to return to their offices five days a week. Sources who spoke to Focus said FDA employees were told this week they would need to start working from the agency headquarters in White Oak, MD, starting 17 March. Agency staff with managerial oversight have also been told they must return to the office five days a week if they live within 50 miles of their headquarters or duty stations starting 28 February.

Focus contacted HHS and FDA to comment on the directives, but they did not respond by publication time.

A 6 February deadline for federal employees to accept an offer to resign from their jobs by 30 September was delayed until 10 February, after a federal judge paused the offer to allow legal challenges to the Trump Administration's plan to play out in the courts. According to CNN, the administration emailed employees about the pause only hours before it was set to expire.

White House sources said that 65,000 workers have accepted the deferred resignation offer, which accounts for less than 3% of the federal civilian workforce.

The Office of Personnel Management (OPM) sent a memo to federal workers this week defending the legality of its deferred resignation offer, stating that if the government has to backtrack on its commitment after an employee has accepted the offer, "the employee would be entitled to request a rescission of his or her resignation." The memo also stated that nothing in the offer requires congressional approval, which many critics of the move have argued.

OPM also issued a memo asking agency heads to reclassify their chief information officers (CIO), who are part of the Senior Executive Service (SES), as "general" staff rather than "career reserved" staff. Vid Desai is FDA's CIO, and a change in the classification could remove his employment protections and allow the Trump administration to position their pick. The memo comes two weeks after Trump issued an executive order to reclassify SES employees more broadly to give him more power over their employment.

The US Senate Finance Committee voted 14 to 13 down party lines to forward Kennedy Jr.'s nomination to lead the Department of Health and Human Services (HHS) to the Senate floor for a vote. While Republican lawmakers lauded him as a nominee who wants to reform the healthcare system, Democrats warned that his views on vaccines could ultimately hurt Americans.

As the Trump administration has attacked federal diversity, equity, and inclusion efforts, the public health advocacy group the American Public Health Association (APHA) this week raised concerns about a "DEI Watchlist" published by the American Accountability Foundation. CNN reports that the website with the watchlist seems to have been online for a week and includes federal workers, including two officials at FDA.

"The real power often lies with behind-the-scenes bureaucrats who push divisive DEI agendas that undermine merit, fairness, and accountability," the website states. "By uncovering these hidden influencers and their failures, we aim to restore integrity and common sense to our government."

APHA Executive Director Georges Benjamin, said the website was created "to threaten, to intimidate, to scare.”

As the Trump administration goes about scrubbing anything they consider DEI-related from federal websites and other communications, Agency IQ noted that FDA has changed its Form 3500 adverse event reporting form to remove sections that ask about gender identity.

Drugs & biologics

FDA announced it had approved Medexus' cancer drug Grafapex (treosulfan), an alkylating agent, with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT) for patients one-year-old and older with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). The company announced at the end of January that the agency had notified it of the approval and was planning to launch the product in the first half of the year.

Medtech

Misconfigured alert settings, issues with the operating system, and hardware issues may prevent patients who have connected their phones to their diabetes devices from getting crucial alerts. FDA issued a safety alert that it has received reports of patients who may have been harmed or died because of problems with the alert settings on their phones working effectively and provided mitigating steps that users should take.

FDA provided an update on its ongoing evaluation of breast implants, including the potential for breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The agency published a retrospective study of implants between 1 January 2008 and 30 June 2024 and updated its labeling requirements for implants based on what it has learned.

Medline Industries issued a class I recall for its Integrated Arterial Catheters found in Arterial Line Insertion kits after discovering a manufacturing issue that led to excess material in the catheter hub, which could lead to the material detaching and entering the patient's bloodstream. According to FDA, the company has asked users not to use the affected catheters.

FDA issued an early alert for Bard Peripheral Vascular's Rotarex Atherectomy Systems due to concern that certain patient anatomical characteristics, such as vessel size, angulation, tortuosity, degree of calcification, and procedural factors, such as contralateral access, sheath kinking, lack of continuous blood flow, and catheter advancement-related factors, could lead to helix fracture and/or breakage events. The company is a subsidiary of Becton, Dickinson, and Company (BD) and has sent letters to customers potentially affected by the products.

Medtronic Neurosurgery issued a class I recall for certain Becker and Exacta EDMS due to a risk of cracks and/or leaks in device stopcocks. The devices are used to drain cerebrospinal fluid (CSF) from specific parts of the brain and monitor CSF pressure and flow rate from these areas. The devices in question could result in leaks of cerebrospinal fluid, infections, and death.

Baxter has issued a class I recall for its Life2000 Ventilators due to a battery charger problem that triggers battery alarms and renders the devices inoperable. The company told users if their ventilator is working properly, they should keep using it, but they should have alternate means of ventilation or oxygen therapy available.

Jiangsu Jumao X-Care Medical Equipment has issued a class I recall for its TRUAIRE-5 O2 CONCENTRATOR (Model O2C5L) used to provide supplemental oxygen to patients with respiratory disorders after it received reports of devices melting and catching fire during use. The company has asked users to return the affected devices.

This Week: Federal workforce cuts, Trump buyout offer delayed, and FDA’s RTO

Related topics

Recommended content

Welcome to the new RAPS Digital Experience