This Week at FDA: Trump fires thousands of federal workers, Kennedy sworn in as HHS secretary, and more

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, Robert Kennedy Jr. was sworn in as HHS secretary and the Trump Administration has begun a massive purge of federal workers targeting probationary employees, with more firings expected in the near future.

Spearheaded by the Department of Government Efficiency (DOGE), the Trump Administration has laid off thousands of federal employees across multiple agencies, according to multiple sources. STAT News reported that the administration planned to fire about 5,200 probationary workers within the Department of Health and Human Services (HHS), of which about 1,300 are expected to be from the US Centers for Disease Control and Prevention (CDC).

Focus reached out to HHS about layoffs affecting of probationary workers, including at the Food and Drug Administration (FDA), but the department declined to provide specific details. "HHS is following the Administration’s guidance and taking action to support the President’s broader efforts to restructure and streamline the federal government. This is to ensure that HHS better serves the American people at the highest and most efficient standard,” HHS spokesperson Andrew Nixon told Focus.

Kennedy was confirmed as the new HHS secretary in a 52 to 48 vote down party lines. Former Senate majority leader Mitch McConnell (R-KY), a polio survivor, was the sole Republican who voted against Kennedy’s confirmation because of his views on vaccines.

US District Judge John Bates ordered HHS, CDC, and FDA to restore websites and data that were removed to comply with President Donald Trump's executive order to delete information that includes gender ideology, according to CBS News. The judge granted the temporary restraining order as part of lawsuit proceedings brought against the administration by Doctors for America.

Soon after being sworn in by Supreme Court Justice Neil Gorsuch at the White House, Kennedy told reporters that he planned to institute radical transparency; return NIH, CDC, and FDA to using gold standard science; end corruption and corporate capture; and eliminate people on expert panels who have conflicts of interest.

Later in the day, Kennedy told Fox News' Laura Inghram that he had a generic list of HHS officials that he wanted to fire. He argued that these officials had made bad decisions and shown themselves working for the pharmaceutical industry. During his nomination hearings, Kennedy made similar statements and said he would fire about 600 HHS officials as soon as he became secretary.

Kennedy has criticized perceived links between FDA and the industries it regulates, which could put issues such as product user fees in his crosshairs. Former FDA Commissioner Scott Gottlieb suggested that FDA-regulated industries that have user fee agreements with the agency should consider lobbying to extend the current agreements for another year or two before they start negotiating reauthorization agreements, according to InsideHealthPolicy. He said they could try adding the extensions to the upcoming budget reconciliation bill.

Former FDA Commissioner Robert Califf has returned to Duke Health as a faculty member at the Division of Cardiology. Califf said he intends to use his new position to address medical misinformation and cardiometabolic disease.

Drugs & Biologics

Moderna announced that FDA has placed a hold on its phase 3 trials of its norovirus vaccine, mRNA-1403, after an adverse event in which a participant was diagnosed with Guillain-Barré syndrome. The company said it is investigating the case but does not expect it to impact the study's efficacy readout timeline.

The Center for Biologics Evaluation and Research (CBER) has published information on its Regenerative Medicine Advanced Therapy (RMAT) Designations program. The center's data shows that fiscal year 2024 was a record year for the program as it received 59 RMAT designation requests and granted 43 requests.

FDA posted a digital catalogue containing nearly 1,000 historical monograph drug documents. This includes paper documents collected prior to the passage of the Coronavirus Aid, Relief, and Economic Security (CARES) Act. The law granted FDA the authority to assess and collect fees from regulated industry under the OTC Monograph User Fee Program, or OMUFA. Before OMUFA, the FDA lacked the resources to catalogue and archive approximately 300 boxes of paper documents that contained valuable data to support order requests from the industry.

CDER announced that it had qualified a drug development tool (DDT) that sponsors of alcohol use disorder (AUD) treatments can use to develop their products. The 2-level reduction in the World Health Organization (WHO) risk drinking levels (RDL) of alcohol consumption can be used as a new endpoint to determine if AUD treatments work.

FDA re-issued an alert to healthcare providers about the risk of medication errors from tranexamic acid injections used to treat hemophilia. The agency issued a similar alert in 2020. It said it continues to receive reports of the injections being erroneously administered intrathecally instead of the intended intrathecal (spinal) anesthetic, which could result in severe adverse events, including death.

SpringWorks Therapeutics's Gomekli (mirdametinib), a kinase inhibitor, was approved to treat patients 2 years and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection. The company said FDA had granted it a rare pediatric disease priority review voucher (PRV).

FDA announced the approval of Seagen’s Adcetris (brentuximab vedotin) in combination with lenalidomide and a rituximab to treat adult patients with relapsed or refractory large B-cell lymphoma (LBCL). It is indicated for those patients who have failed two or more lines of systemic therapy and are ineligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or CAR T-cell therapy.

FDA approved the first rapid-acting insulin biosimilar product for treating diabetes. The drug Meriloq (insulin-aspart-szjj) is manufactured by Sanofi-Aventis and is a biosimilar to Novolog (insulin aspart). It is intended to improve glycemic control in diabetes patients.

Medtech

The cosmetics manufacturer Evolus announced that FDA has approved two premarket applications (PMAs) for its Evolysse Form and Evolysse Smooth injectable hyaluronic acid (HA) gels as HA dermal fillers.

FDA announced that Abiomed had revised the instructions for its Impella RP with SmartAssist and Impella RP Flex with SmartAssist heart pumps. The updates include a warning for healthcare providers about a potential risk where the tip of the guidewires may come into contact with the heart pumps during insertion or removal and “may cause serious injury or death” if used without following updated instructions. The agency said the product is not being removed and does not need to be returned.

FDA announced that Sentec and Percussionaire have issued a recall for their VDR4 Phasitron breathing circuit kits. The recall was due to a malfunction of one of its components that may reduce pressure and volume flow and could cause serious injury or death if used.

This Week at FDA: Trump fires thousands of federal workers, Kennedy sworn in as HHS secretary, and more

Related topics

Recommended content

Welcome to the new RAPS Digital Experience