This Week at FDA: Lawmakers look to fund FDA, HHS’ shutdown RIF, 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 lawmakers are working to pass a potential “minibus” budget bill to fund FDA and HHS admitted to accidentally laying off more staff than it meant to amid the ongoing government shutdown.

While Senate Republican leaders are trying to pressure Democrats to help them pass a full-year spending bill more than two weeks into a government shutdown, Politico reports that they are also trying to move forward on a "minibus" package with their House counterparts that would fund several key agencies, including FDA. Before the shutdown, the Senate had passed three funding bills, including an agriculture-FDA funding bill, and was making progress with colleagues on the House side to resolve their differences.

NOTUS reported that during the government shutdown last week, the Department of Health and Human Services (HHS) accidentally sent reduction-in-force notices to twice as many employees as intended. Thomas Nagy Jr., HHS Deputy Assistant Secretary for Human Resources, admitted that due to "data discrepancies and processing errors," 1,760 employees received notices that they had been fired, instead of the 982 employees that the emails were intended for.

STAT News reported on the unusual course of events that George Tidmarsh, director of the Center for Drug Evaluation and Research (CDER), took to ask his scientific staff to consider leucovorin as a treatment for autism. The center staff pushed back against the idea and Tidmarsh eventually compromised to ask GlaxoSmithKline (GSK), the original drug manufacturer, to submit an application to treat cerebral folate deficiency; a rare neurological disorder that often has similar symptoms to autism.

A Kaiser Family Foundation and Washington Post survey found that four-in-10 American parents supported the Make America Healthy Again (MAHA) movement, and support of HHS Secretary Robert Kennedy Jr.'s movement is closely correlated with their political identification. However, only about half of those identified as MAHA said they trust Kennedy to provide reliable vaccine information.

Drugs & biologics

The Center for Biologics Evaluation and Research (CBER) published a standard operating policy and procedure (SOPP) for staff on where to find lists of disqualified and restricted clinical investigators, debarred researchers, and companies that are under the application integrity policy available on the agency's website. It also instructs its staff to review the Public Health Service (PHS) list of people who have been debarred or suspended by the Department of Health and Human Services (DHHS) Office of Research Integrity.

CBER also approved Stanford Blood Center's biologics licensing application (BLA) for convalescent plasma from patients who have recovered from COVID-19 as a safe and effective treatment for the disease when sufficiently high titers are used in patients with immunosuppressive disease or receiving immunosuppressive therapies. The agency said the risks associated with using COVID-19 convalescent plasma (CCP) are comparable to conventional plasma.

FDA published a final guidance that provides technical recommendations on handling data sets in clinical trials when determining efficacy in new drug applications (NDAs) and biologics license applications (BLAs) for acute leukemia drugs. The agency emphasized that the recommendations in the guidance are intended to complement and not supplant the clinical development program and efficacy endpoint recommendations in disease-specific guidances.

The agency also published a Form 483 given to Hetero Labs Limited following a September 2025 inspection of its Andhra Pradesh active pharmaceutical ingredient facility listing six observations related quality control, documentation, and recordkeeping.

Medtech

FDA issued a safety communication for radiofrequency (RF) microneedling devices, which are used to locally apply heat under the skin in dermatologic and aesthetic procedures to treat wrinkles, among other applications. The agency said it has received reports of people getting burned, scarred, losing fat, getting disfigured, getting nerve damage, and receiving surgery to treat their injuries.

Roche's Elecsys pTau181 test, developed in collaboration with Eli Lilly, has been cleared by FDA as the only blood-based biomarker (BBM) test intended to allow an initial assessment for Alzheimer’s disease and other causes of cognitive decline in a primary-care setting. The test measures phosphorylated Tau (pTau) 181 protein in plasma, a key biomarker for Alzheimer’s, including amyloid plaque and tau aggregate pathology, and is intended to help with initial diagnoses of patients ages 55 and older who show signs of cognitive decline.

This Week at FDA: Lawmakers look to fund FDA, HHS’ shutdown RIF, and more

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