This Week at FDA: Speedy drug review bonuses, Makary defends Prasad, 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 reportedly offered drug reviewers bonuses to speed regulatory decisions, the FDA commissioner defended the head of the biologics center, and a second product has been approved under the commissioner's new voucher program.

Several outlets, including the Associated Press, reported that FDA plans to start offering bonuses to its drug reviewers who finish their work ahead of schedule. FDA Commissioner Marty Makary described the bonus payment initiative as a pilot program during a staff meeting and stated that the first bonuses would be sent out starting in August.

Makary also defended Vinay Prasad, director of the Center for Biologics Evaluation and Research (CBER), on CNBC's Squawk Box after being asked by co-host Becky Quick about a recent editorial piece in the Wall Street Journal. The article argued that while Makary was trying to speed rare disease treatments to market, Prasad was undermining those efforts.

“There has been sort of this effort to put a Fatwa on Vinay Prasad by one or two media outlets as if he's the one making these decisions,” he said.

Co-host Joe Kernen asked why Prasad was working in the Trump administration, given his past statements supporting Sen. Bernie Sanders (I-VT), a democratic socialist.

“That's part of the smear campaign. I'm picking the best scientists. Vinay Prasad loves President Trump,” said Makary. “He did support Bernie Sanders in the past, but he saw the incredible revolution with President Trump and is an ardent supporter of President Trump.”

FDA has published the latest meeting minutes in its negotiations with industry for its Generic Drug User Fee Amendments (GDUFA IV), Prescription Drug User Fee Act (PDUFA VIII), and Medical Device User Fee Amendments (MDUFA VI) negotiations.

Barclay Butler, FDA's deputy commissioner for operations and chief operating officer (COO), published a blog post explaining circumstances in which the agency cannot disclose information that may be confidential commercial information (CCI), personal privacy information, privileged intra-agency documents, or law enforcement records. “The FDA must maintain a delicate balance: being a model of openness regarding the scientific basis of its decisions, while safeguarding the proprietary secrets of the industries it regulates,” he stated. “This isn't just a bureaucratic preference, it is a legal mandate.”

FDA's Division of Applied Regulatory Science (DARS) published its 2025 annual report, which notes that it conducted 49 applied research projects last year. It also stated that it conducted 15 global collaborations, published 30 manuscripts, presented 19 posters, and delivered 20 external presentations.

FDA announced it will publish a slew of additional draft and revised draft product-specific guidances that address topics such as the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). It includes 29 new and 56 revised drug product-specific guidances.

Drugs & Biologics

Boehringer Ingelheim's kinase inhibitor Hernexeos (zongertinib) was granted accelerated approval by FDA for an expanded indication to treat adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, diagnosed with an FDA-authorized test. The drug was approved under the agency’s controversial new Commissioner's National Priority Voucher (CNPV) pilot program, with approval occurring in only 44 days after the filing date. It was also reviewed under its Real-Time Oncology Review (RTOR) pilot program and was granted priority review.

Pfizer's subsidiary Array BioPharma's kinase inhibitor Braftovi (encorafenib) in combination with cetuximab and fluorouracil-based chemotherapy was approved by FDA to treat adults with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, diagnosed with an FDA-authorized test. FDA noted that the drug received accelerated approval in combination with cetuximab and mFOLFOX6 for metastatic colorectal cancer with BRAF V600E mutation in 2024 and was reviewed through the RTOR pilot program.

Sanofi and Regeneron's Dupixent (dupilumab) was approved by FDA to treat patients 6 years and older with allergic fungal rhinosinusitis (AFRS) with a history of sino-nasal surgery. The agency noted it is the first treatment for the rare chronic sinus inflammation condition caused by an allergic reaction to fungi in the sinuses.

FDA is scheduled to host its two-day “Fiscal Year 2026 Generic Drug Science and Research Initiatives Workshop” starting 8 June. The agency highlights that it will be an opportunity to learn about the status of science and research initiatives for generic drugs and for public input.

Medtech

The Center for Devices and Radiological Health (CDRH) published the 2026 first quarter report on its performance under the Medical Device User Fee Amendments (MDUFA V). Among the findings, it notes that the rate of first-cycle major deficiency letters for premarket approval (PMA) and panel track supplements dipped from 82% in 2024 to 74% in 2025, while final decisions to approve such products went up from 84% to 88% during the same timeframe.

Fresenius Kabi issued a Class I recall for its Ivenix Large Volume Pump (LVP) due to concerns that the pump's software contains anomalies that may be life-threatening. Users have been advised to update the software before use.

Boston Scientific has issued a class I recall for certain Axios stents and Electrocautery-Enhanced Delivery Systems due to reports of issues with stent deployment and expansion that may delay deployment, according to FDA. The agency noted that there have been 167 reported serious injuries and three deaths associated with the issue as of 23 December 2025.

Olympus issued a class I recall for its High Flow Insufflation Unit, models UHI, UHI-2, and UHI-3, due to a software issue that could potentially cause overpressure events, according to FDA. The agency said the company reported two serious injuries due to the issue and noted that the products have been discontinued, unsupported for many years, and have been pulled from the market.

FDA issued an early alert for Abiomed's Impella Purge Cassettes and Impella RP Pump Sets after reports that the devices have an increased risk of purge leaks. If a purge leak occurs, the agency said it could lead to low pressure, which may then cause biomaterial ingress and stop the pump from working, potentially becoming life-threatening.

This Week at FDA: Speedy drug review bonuses, Makary defends Prasad, and more

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