This Week at FDA: HHS proposes drug acceleration initiatives, FDA warns companies about falsifying test data, 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 HHS proposed several big measures to accelerate drug development, FDA warned about third-party testing facilities falsifying drug data, and the agency published several reports on the state of the drug industry and clinical trials.
The big news this week is that the Department of Health and Human Services (HHS) announced "Operation Trailblazer," an initiative that includes a series of measures designed to speed up drug development. For its part, FDA proposed a pilot program where qualified external institutions can collaborate with sponsors to develop and review protocols for first-in-human (FIH) clinical trials intended for investigational new drug (IND) submissions, and several associated draft guidances, including one clarifying when developers can rely on one rigorous, adequate, and well-controlled clinical trial, along with confirmatory evidence, to support drug approvals.
FDA issued general correspondence letters to several Chinese third-party testing facilities for falsifying data and issued a statement that it has noticed an increase in unreliable testing data generated by such entities on behalf of device manufacturers and sponsors. The agency said that copying or falsifying data has led to regulators’ reluctance in relying on the data for marketing authorizations.
The Office of Pharmaceutical Quality published its annual Report on the State of Pharmaceutical Quality, which summarizes the state of pharmaceutical manufacturers, drug products, postmarket quality defects, import alerts, recalls, and warning letters. The report noted that at the end of last year, there were 5,953 pharmaceutical manufacturing sites, of which 57% were domestic. It also noted that the number of drug quality assurance inspections increased from 972 in FY2024 to 1,248 in FY2025, with a significant shift toward more international inspections.
The Center for Drug Evaluation and Research (CDER) also published its annual Drug Trials Snapshots Summary Report, intended to provide healthcare professionals and consumers with information on the demographics of participants in FDA-approved drug clinical trials and where the trials were conducted. The agency noted that it approved 46 novel drugs and biologics last year, including 43% that were first-in-class, and half that were for rare or orphan diseases.
The over-the-counter (OTC) Monograph Drug User Fee Program (OMUFA) arrears and paid facilities lists have been updated by FDA on its website. The agency reminded companies that if they don't pay their annual facility fee within 20 calendar days of the due date, they will be listed on the publicly available arrears list.
Drugs & Biologics
The Center for Biologics Evaluation and Research (CBER) announced it has approved a supplement to Genzyme's Biologics License Application (BLA) for its kidney transplant organ rejection drug Thymoglobulin (anti-thymocyte globulin, Rabbit). The supplement requires the company to update its labeling to include the risk of thrombotic microangiopathy, in which blood clots may form in blood vessels, restricting blood flow and causing organ damage.
Gilead's Trodelvy (sacituzumab govitecan-hziy) was approved by FDA for two indications, including as a first-line treatment for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1 or PD-L1 inhibitor-based therapy. It was also approved in combination with Merck's Keytruda (pembrolizumab) or Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) for the first-line treatment of adults with unresectable locally advanced or metastatic TNBC whose tumors express PD-L1 (CPS ≥ 10) as determined by an FDA-authorized test.
Ionis Pharmaceutical's Tryngolza (olezarsen) in conjunction with diet has been approved by FDA to reduce triglycerides and the risk of acute pancreatitis in adults with severe hypertriglyceridemia. The drug is intended to be injected subcutaneously once a month.
Pfizer's cancer drug Ibrance (palbociclib), in combination with trastuzumab, with or without pertuzumab, and endocrine therapy, has been approved to treat adult patients with HR-positive, HER2-positive locally advanced or metastatic breast cancer following induction treatment. The drug had received breakthrough therapy designation.
Medtech
GE HealthCare issued a class I recall for certain Giraffe and Panda infant resuscitation systems and warmers with a M1091607-R Blender due to concerns that the air-oxygen blender knob shaft on some devices can loosen, affecting oxygen delivery concentration. The issue can cause hypoxia or hyperoxia, and the company has asked users to stop using the systems until the issue is corrected.
Abiomed has updated the use instructions as part of its class I recall for certain automated Impella controllers due to concerns that, under certain circumstances, the devices may be forced to restart due to an internal software error that may delay treatment and increase risk for serious injury or death due to a lack of hemodynamic support. So far, the company says it has received reports of two serious injuries and a death associated with the issue.
FDA announced it was downclassifying a slew of medical devices to class II with special controls. The list includes external lower extremity nerve stimulators for restless legs syndrome, computerized behavioral therapy devices for the treatment of fibromyalgia symptoms, SARS-CoV-2 serology tests, infant supine sleep systems, foam or gel chemical sterilant/high-level disinfectants, breast implant suction retrieval systems, and prognostic tests for diagnosing the development or progression of preeclampsia.
