This Week at FDA: FDA layoffs, resignations, 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, the Trump Administration fired thousands of probationary workers at federal health agencies, including FDA, and the head of FDA's food program and a top official from its biologics center have resigned.

Mass layoffs hit FDA last weekend, as an unknown number of probationary were fired as part of the Trump Administration’s effort to shrink the federal government. While the administration has not provided any specifics on the scope of the reductions, the round of firings, which affected thousands of staff across several federal health agencies, targeted probationary workers with fewer employment protections.

Some tallies of the layoffs have emerged since the weekend, with Reuters reporting that a White House spokesman confirmed that more than 1,000 FDA employees were laid off across the agency, at least 180 of which were being paid, at least in part, via user fees collected under the Medical Device User Fee Amendments (MDUFA V). The medtech lobby group AdvaMed has written to the Department of Health and Human Services (HHS), calling on it to reverse the firings, arguing that the layoffs would harm both industry and patients.

Jim Jones, FDA’s deputy commissioner for foods, resigned in protest after 89 members of his center were fired, saying that despite the administration's talk of improving the well-being of Americans, the firings had "decimated" the agency's ability to evaluate food nutrition and chemical safety. He told STAT News that it was "very troublesome" that the newly appointed HHS Secretary Robert Kennedy Jr. thinks of FDA employees as corrupt. During his confirmation hearing, Kennedy repeatedly said he had a list of 600 HHS officials that he planned on firing as soon as he was appointed head of the department.

AgencyIQ and Endpoints News have both reported that Celia Witten, a deputy director at the Center for Biologics Evaluation and Research (CBER), has also left the agency.

Earlier in the week, HHS Secretary Robert Kennedy Jr. held a meet-and-greet with HHS staff where he told workers he plans to "investigate" whether the timing of childhood vaccinations and anti-depression medications are "possible factors" contributing to chronic diseases, according to ABC News. He reportedly told staff that no topics would be off limits and urged them to keep an open mind.

Politico reported that Kennedy plans to axe external experts who he deems have conflicts of interest with industry and sit on advisory committees advising the federal government on vaccines and other health topics. Sources said he will likely start by targeting the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP), which makes recommendations about vaccine policy.

ACIP was scheduled to meet between 26 and 28 February to discuss several vaccines, including meningococcal, influenza, and Human Papillomavirus (HPV) vaccines, but the meeting was postponed this week. A notice on the committee's website says it was postponed "to accommodate public comment in advance of the meeting."

Drugs & biologics

CBER’s Office of Therapeutic Products (OTP) will host a virtual public workshop on 25 February. This week, it updated the agenda for that meeting, where it plans to bring stakeholders together to discuss how to generate scientific evidence for developing cell therapies and tissue-based products.

FDA removed semaglutide injection products from its drug shortages list, stating it has confirmed with manufacturers that they have enough product availability and manufacturing capacity to meet consumer needs. The agency said it would not go after compounders who manufactured the drug while it was in shortage. However, it said it may take actions for other violations, such as if the compounded drug is substandard or unsafe.

Fierce Pharma reported that Pfizer has decided to stop the global development and commercialization of its hemophilia gene therapy Beqvez (fidanacogene elaparvovec-dzkt) for several reasons, including a lack of interest from patients and physicians. According to Fierce, no patients have received the commercial version of the gene therapy since it was approved last year.

Mirum Pharmaceuticals' drug Ctexli (chenodiol) has been approved to treat adults with cerebrotendinous xanthomatosis (CTX), a rare lipid storage disease. Before approval, FDA granted the drug priority review, fast track, and orphan drug designations.

ICU Medical has issued a recall for lots of its potassium chloride injections, 20 mEq and 10 mEg, due to a manufacturing error that led to mislabeling. The company has received customer complaints about the error and has issued the recall to prevent adverse events that could lead to fatal overdosing.

BD (Becton, Dickinson and Company) has issued a worldwide recall for one lot of its ChloraPrep Clear 1 mL Applicators after discovering fungal contamination under certain environmental conditions that allow the growth of the fungus Aspergillus penicillioides. The product is used to prepare surgical sites before procedures and could inadvertently cause fungal infections in patients.

Medtech

The Harmed Americans for Reform in Medical-Device Safety Corp. (HARMS) has filed a citizen petition asking FDA to review newly published studies on the use of robotic surgery for mastectomy operations to treat breast cancer. The group argued the agency should publish new guidance and update its safety communications, stating that there is a lack of evidence supporting the use of robotic surgery in mastectomy operations.

FDA published a warning letter that it had issued Robbins Instruments on 21 January for selling its Dermo-Jet Needleless Injectors without proper marketing clearance or approval and for violating quality system regulations (QSR) and medical device registration and listing violation. The company was told to cease commercial distribution of the products immediately.

FDA announced it has extended the expiration dates for certain COVID-19 tests, including Wondfo USA's WELLlife COVID-19 / Influenza A&B Home Test. The agency also noted that US households are eligible to receive four free COVID-19 tests from the government.

This Week at FDA: FDA layoffs, resignations, and more

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