This Week at FDA: Pregnancy exposure registries, PRV fee rates, 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, FDA said it wants to conduct research into perceived barriers to enrolling women in pregnancy exposure registries, the agency announced priority review voucher fees for the next fiscal year, and it named permanent leaders to three of its product centers.

FDA issued a request for feedback on a proposed Pregnancy Exposure Registry Enrollment Project to survey healthcare providers about perceived barriers to patient enrollment in pregnancy exposure registries. The agency said many registries fail to adequately enroll pregnant women to understand the safety and potential toxicity of prescription products, and the survey is intended to address that. The agency said it plans to collect 400 completed surveys from primary care providers, consulting physicians, and pharmacists to gather insights on their awareness of pregnancy exposure registries, their experience with them, their perceived barriers to patient enrollment, and what they think could be done to improve participation.

On Wednesday, FDA announced the fee rate for priority review vouchers for the fiscal year 2027 for applications that are intended for drugs and biological products to treat tropical diseases, rare pediatric diseases, or for its material threat medical countermeasure (MCM) priority review voucher. All priority review vouchers will be $1,798,596, in addition to their Prescription Drug User Fee Amendments (PDUFA) fees.

Earlier this week, FDA announced that Michael Davis will lead the Center for Drug Evaluation and Research (CDER), Karim Mikhail will lead the Center for Biologics Evaluation and Research (CBER), and Bret Koplow will lead the Center for Tobacco Products (CTP). All three had been leading their respective centers in an acting capacity until Tuesday’s announcement. The agency also announced that Jared Seehafer will serve as its first deputy commissioner for technology and artificial intelligence.

FDA issued a temporary guidance on compounding neonatal starter PN that went into effect immediately after children's hospitals raised concerns about a potential shortage after two outsourcing facilities that made the products began to shut down. The agency said the guidance is intended to help address potential supply gaps and support hospitals in maintaining access to the products while longer-term solutions are identified.

Politico reported that during an FDA and Reagan-Udall Foundation for the FDA meeting on opioids, Wilson Compton, deputy director for the National Institute of Drug Abuse, expressed enthusiasm for the Trump administration's focus on psychedelic therapies and their potential as alternatives to opioids to treat addiction and pain. The discussion with regulators and other experts was intended to inform a December congressionally mandated report on evaluating the public health effects of opioids.

The Reagan-Udall Foundation for the FDA and FDA are also co-hosting a hybrid meeting on 16 October to discuss where the patient voice is needed in the rare disease product development timeline, its impact, and opportunities for patients to engage in the product development process. The aim is to develop recommendations for medical product manufacturers and regulators.

External experts on the Vaccines and Related Biological Products Advisory Committee (VRBPAC) are scheduled to meet on 1 October to discuss strain selection for influenza virus vaccines for the 2027 Southern Hemisphere influenza season and provide recommendations. As usual, FDA said it would publicly provide background material for the meeting two days before the meeting.

FDA published updated over-the-counter (OTC) Monograph Drug User Fee Program (OMUFA) arrears and paid facilities list on its website. The list includes facilities that have not satisfied their fee requirements.

Former FDA Chief Counsel Mark Raza has joined the law firm Hogan Lovells Cadwalader as a senior counsel in its Pharmaceuticals and Biotechnology practice at its Washington DC office. A 35-year veteran of the agency, Raza joins several former FDA staffers who have recently been hired by the law firm, including Melissa Mendoza, former director of FDA’s Office of Compliance and Biologics Quality at CBER, and Elizabeth Jungman, former head of CDER’s Office of Regulatory Policy and former chief of staff to the FDA commissioner.

Drugs & Biologics

Pharming's drug Joenja (leniolisib) was approved as the first treatment for activated phosphoinositide 3-kinase delta syndrome (APDS) in children 4-11 years who weigh at least 27 kg. The drug had already been approved in 2023 for children 12 years and older with the same disease.

Bayer's cancer kinase inhibitor Hyrnuo (sevabertinib) was granted accelerated approval to treat adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations based on an FDA-authorized test. FDA notes the approval extends the current accelerated approval indication for the drug to treat adults with the disease who have received prior systemic therapy.

Reuters reported that FDA has extended the review of Exelixis' experimental colorectal cancer drug ‌zanzalintinib in combination with Roche's immunotherapy Tecentriq to treat a subset of adults with metastatic colorectal cancer by three months and will provide an answer to the company by 3 March 2027. According to the company's filing, it provided regulators with updated safety and efficacy data that was considered a major amendment.

Medtech

Medical Action Industries' correction for certain epidural kits with Spectra Medical Devices' lidocaine ampules made by Huons has been classified as a Class I recall by FDA. Medical Action said the sterility of the flush solution may be compromised, exposing patients to microorganisms, endotoxins, and/or foreign matter.

FDA classified several devices as Class II products with special controls, including extravascular support devices for arteriovenous fistula for vascular access; mechanical deviation devices for esophageal protection during cardiac ablation procedures; temperature regulation devices for esophageal protection during cardiac ablation procedures; anti-tumor necrosis factor alpha monoclonal antibody test systems for inflammatory bowel disease; cooperative powered surgical assist devices for ear, nose, and throat surgery; implanted tibial electrical urinary continence devices; whole room microbial reduction devices; vaginal hydrogel packing systems; and cardiovascular machine learning-based notification software. The devices all come with mitigation requirements, including clinical and non-clinical performance testing, biocompatibility testing, sterilization validation, labeling requirements, and more.