This Week at FDA: Makary and a CRL for KalVista, more FDA staff leaving, advisory panels slowed by staff cuts

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, we learned that more top FDA officials are leaving the agency, read reports that FDA Commissioner Marty Makary sought to issue a CRL to KalVista, and noted that agency staff are concerned that recent cuts are slowing advisory committee meetings.

Endpoints News reported that Makary lobbied to issue a Complete Response Letter (CRL) to KalVista Pharmaceuticals to decline approval of its rare disease drug sebetralstat to treat hereditary angioedema. Seeking Alpha noted that on 13 June, the company issued a statement that FDA would not meet its Prescription Drug User Fee Amendments (PDUFA) target date due to the agency’s “heavy workload and limited resources.” Following the announcement Seeking Alpha notes that sources said FDA “higher-ups” tried to persuade CDER leaders to issue the CRL but were denied the request because it may be seen as “arbitrary and capricious.”

"The important takeaway from [the Endpoints News article] is that Makary appears to have pursued the CRL as punishment for KalVista publicly announcing that its product had been delayed as the result of FDA capacity constraints," wrote Alec Gaffney in AgencyIQ’s FDA Today: Life Sciences newsletter. He added that a key takeaway from the incident is that "Makary appears to be willing to aggressively guard the reputation of the agency and of his leadership, even if it means breaking norms, punishing companies."

FDA published its annual report on the makeup of clinical trials of the drugs that it has approved. Gaffney noted that the agency approved Piasky, Exblifep, Unloxcyt, and Aqneursa based on trials that did not include any US participants, and approved several other drugs and biologics based on trials with very low US participation.

"This could raise questions by the FDA’s new leaders (or Congress) about whether federal regulations are discouraging US-run clinical trials," Gaffney wrote. "We should also note that we are surprised to even see this report because it also indicates the extent to which patients of different ethnicities (white, Black, Asian, and Hispanic) enrolled in supporting trials – a sensitive topic in the Trump administration."

After news this week that Jacqueline Corrigan-Curay, acting director of the Center for Drug Evaluation and Research (CDER) and its principal deputy director, was retiring from FDA in July, the agency announced that Mike Davis, a former lead physician at the CDER Division of Psychiatry was returning to serve as CDER deputy director. BioSpace noted that David most recently served as chief medical officer at Usona Institute, a non-profit medical research organization (MRO) that is developing psychedelic drugs.

Lizzy Lawrence of STAT News reported on X that Tala Fakhouri, FDA associate director for data science and AI policy, was leaving the agency. She also reported that current and former FDA staff have raised concerns that recent staff cuts at FDA are making it difficult for the agency to host advisory committee meetings, adding that at least three meetings have either been postponed or canceled since the new administration took the reins.

Politico Pro reported that Republicans in the House Appropriations Committee passed a FY 2026 FDA budget in a 35-27 vote down party lines. If passed by Congress as is, the bill would cut the FDA appropriation by $300M to $3.2B and include another $3.6B from medical device user fees.

Drugs & Biologics

FDA announced it is requiring COVID-19 vaccines to include a warning about the potential for myocarditis and pericarditis after vaccination. The agency said it is also requiring manufacturers to include the new safety information in the adverse reactions section of the prescribing information and in the information for recipients and caregivers.

FDA granted accelerated approval to Daiichi Sankyo’s Datroway (datopotamab deruxtecan-dlnk) to treat locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy. The cancer drug comes with a warning that it may cause interstitial lung disease/pneumonitis, ocular adverse reactions, stomatitis, and embryo-fetal toxicity.

Medtech

GE HealthCare issued a Class I recall earlier this year for certain Carestation anesthesia delivery systems due to reports that they may not effectively provide ventilation when used in Volume Control Ventilation (VCV) mode. FDA said the company has sent urgent medical device correction notices to users.

Medline Industries issued a Class I recall for certain lots of their medical procedure kits that include recalled Medtronic Aortic Root Cannulas that may have excess material in the male luer. The company has provided stickers to put on the kits stating that users should use an aortic root cannula from other suppliers.

ZOLL Circulation issued a Class I recall for its automated, portable, and battery-powered AutoPulse NXT Resuscitation Systems due to a failure code that may cause it to stop or not perform deep enough compressions, which may delay cardiopulmonary resuscitation (CPR). FDA said the company is asking users to stop using the affected devices and return them so it can update them.

FDA issued import alerts for several Olympus Medical Systems products and those from its subsidiaries, including ureterorenoscopes, bronchoscopes, laparoscopes, and automated endoscope reprocessors. The agency said it has concerns about the company's adherence to quality system regulations (QMR) and issued the import alert to prevent further imports of its products.

FDA issued an early alert for certain Medtronic Bravo CF esophageal pH monitoring capsules due to concerns that due to a manufacturing error they may not properly attach to a patient’s esophagus or detach from the delivery device that could lead to aspiration or inhalation, perforation of esophagus, airway obstruction, hemorrhaging, blood loss, bleeding, esophagus laceration, delay in diagnosis, and foreign bodies remaining in the patient. The agency said it is monitoring the issue and will update the public when it knows more.

Cook Medical issued a Class I recall for its Beacon Tip 5.0 Fr angiographic catheters after it received reports that the tips on some of the catheters had separated. The company provided a list of the affected devices and asked users to stop using them.

This Week at FDA: Makary and a CRL for KalVista, more FDA staff leaving, advisory panels slowed by staff cuts

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