This Week at FDA: Overton confirmation hearing, animal testing rule, 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, Senators grilled President Trump’s nominee to lead FDA during her confirmation hearing, and the agency published a rule to aimed at reducing animal testing.
On Thursday, the Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing to review White House aide Heidi Overton's qualifications to serve as the next FDA commissioner. President Donald Trump tapped the physician and health policy advisor to lead the agency last month, and she was questioned by lawmakers from both parties about vaccines, the abortion drug mifepristone, and more.
Continuing its efforts to reduce reliance on animal testing, FDA published a direct final rule this week updating terms to clarify that non-animal methods can be used appropriately to test drugs and biologics. The rule replaces terms such as “animal tests” and “animal studies” with broader language: “nonclinical tests” and “nonclinical studies” and added a definition of the terms to its regulations based on language in the 2022 Food and Drug Omnibus Reform Act.
The US District Court for the District of Minnesota issued a permanent injunction against Gold Star Distribution, Inc., a Minnesota-based multi-commodity warehouse operator, and its owner, Bassam Abu Samrah, after FDA inspectors found insanitary conditions at its facilities, where it receives and holds food, drugs, medical devices, and cosmetics for distribution. Investigators found rodent and pest infestations at the facilities, and the company has been ordered to stop operations until it meets federal legal requirements.
Top FDA statisticians, including John Scott, director of the Division of Biostatistics at the Center for Biologics Evaluation and Research (CBER), will virtually discuss FDA's guidance on using Bayesian methodology in clinical trials for developing drugs and biologics on 24 October. The agency noted that the webinar fulfills a commitment under the Prescription Drug User Fee Amendment (PDUFA VII).
External experts on the FDA's Molecular and Clinical Genetics Panel recommended approving Grail's Galleri blood test, intended to detect up to 50 forms of cancer, which, if approved, would be the first multi-cancer blood test for people 50 and over. In a press release, Grail noted that the committee voted seven to two, with one abstention, that the benefits of the test outweigh its risks; they unanimously agreed that it was safe; and voted six to four that it had proven its effectiveness.
FDA announced its Innovative Science and Technology Approaches for New Drugs (ISTAND) program has accepted a letter of intent (LOI) from BioSensics for its wearable sensor-derived digital outcome measure intended to quantify foot drop severity and its impact on gait in adults with Charcot-Marie-Tooth disease type 1A (CMT1A). If the sensor is qualified as a drug development tool (DDT), it could be used in clinical trials to measure foot drop progression as an efficacy outcome.
Drugs & Biologics
FDA will host a hybrid public meeting on 26 October to discuss proposed agency and industry recommendations for reauthorizing the Biosimilar User Fee Act (BsUFA) for fiscal years (FYs) 2028 through 2032. Stakeholders can comment on the upcoming user fee agreement on www.regulations.gov under docket no. FDA-2015-N-3326 through 25 November.
The Small Business and Industry Assistance (SBIA) office in the Center for Drug Evaluation and Research (CDER) is hosting a hybrid workshop on 29 September to provide the latest updates on registration and listing submissions, including current validation rules. FDA said presenters will discuss evolving regulatory requirements and its compliance framework, as well as strategies for complying with drug amount reporting requirements.
Elevar Therapeutics' kinase inhibitor Lyrfigtu (lirafugratinib) was approved to treat adults with previously treated unresectable, locally advanced or metastatic cholangiocarcinoma harboring a fibroblast growth factor receptor 2 (FGFR2) gene fusion or other rearrangement. The agency noted that the drug had received priority review and had been granted breakthrough therapy and orphan drug designations.
Merck's cancer drug Welireg (belzutifan) in combination with Eisai's Lenvima (Lenvatinib) has been approved by FDA to treat adults with advanced renal cell carcinoma with a clear cell component (ccRCC) following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor. While Welireg has a boxed warning for embryo-fetal toxicity, as well as warnings and precautions for anemia and hypoxia, in combination with Lenvima, it also includes a warning for potential cardiac dysfunction.
Par Health has issued a voluntary recall of two lots of its Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 400 mcg/100 mL (4 mcg/mL), intended for hospitals, due to reports of particulate matter identified as cellulose or stopper material. FDA said the particulates have a reasonable probability of causing life-threatening adverse health consequences, such as pulmonary emboli, occlusions of other blood vessels, and inflammation of the vein walls that may cause clotting.
Otsuka ICU Medical has also issued a voluntary recall for one lot of 0.9% sodium chloride injection, USP, 100mL single-pack, intended for individuals, due to a potential mix-up in which the overwrap labeling states it is 0.9% sodium chloride injection, but the actual product inside may be potassium chloride injection, 10 mEq. FDA noted the issue came to light following a customer complaint in which a 10 mEq highly concentrated potassium chloride injection, 100 mL bag, was found inside an overwrap labeled "0.9% sodium chloride injection, USP, 100 mL."
Medtech
The Center for Devices and Radiological Health (CDRH) is hosting a two-day hybrid workshop starting on 2 December to learn how to evaluate the benefit-risk of robotic medical devices with autonomous or remote capabilities. Attendees will be able to discuss terminology and key technical considerations for developing such robots, learn about the agency's views on benefit-risk, and explore potential future policy considerations.
FDA published a webpage this week with resources for sponsors developing artificial intelligence (AI)-enabled devices. The page includes details on how the agency regulates AI in medical devices, a list of authorized AI-enabled medical devices, and guidance, committees, papers, and other resources sponsors may reference.
FDA issued an early alert for certain Abiomed Automated Impella Controllers (AIC) used as the primary user control interface for the Impella Catheters. The agency said that during a company retrospective review of servicing records, it found that some products required hardware, firmware, and software updates to address safety issues that could delay treatment, provide inadequate treatment, and cause other serious issues.
FDA has also issued an early alert for Ventec Life Systems VOCSN ventilator devices made by its subsidiary React Health. The agency noted that React has reached out to customers with corrective recommendations due to concerns that the internal flow transducer (IFT) cable connector on VOCSN ventilator devices may become partially or fully unseated, thereby losing communication with the internal flow transducer board, which could lead to delays in therapy and other adverse events.
