This Week at FDA: Makary celebrates first 100 days, Senate committee passes FDA budget bill, 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 Commissioner Marty Makary touted his first 100-day record at the agency, the Senate Appropriations Committee advanced an FDA budget bill, and the agency has scheduled several important meetings.

FDA Commissioner Marty Makary issued a statement commemorating his first one hundred days helming the agency, touting his moves to encourage food manufacturers to remove petroleum-based food dyes from their products, reduce animal testing, and establishing the Commissioner's National Priority Voucher (CNPV) program. He also claimed that, under his leadership, the agency is returning to “gold-standard science and common sense.”

Makary also made the rounds cable news on Friday, offering additional details about the CNPV program, which is intended to shorten review times for certain drugs that are considered national priorities.

In response to a question about what qualifies for a voucher on CNBC’s Squawk Box, Makary said, "So, it's a large, unmet public health need. It is a priority identified as part of a US domestic national priority, like the domestication of manufacturing as a national security issue."

He also added that President Trump wants to improve the affordability of drugs, "So, we are including the affordability of drugs as a national priority." On Bloomberg’s Wall Street Week, Makary also said the voucher could be granted to companies that don’t charge more for their products in the US than they do in other developed economies.

"We can issue a national priority review voucher for companies that are promising to equalize the price between other OECD countries and the United States, even with other products that they currently have," he said.

Speaking on Squawk, Makary also repeated criticisms of the agency’s various postmarket surveillance programs, echoing remarks by Department of Health and Human Services Secretary Robert Kennedy Jr.

"Just look at our adverse event reporting systems, they are so clunky ... We have one for vaccines called VAERS, one for devices called MAUDE ... we have 10 different adverse event systems all sort of independently developed," he said. "We're going to go to one, so that way we can have a great user interface and a great database of adverse events that we can use for our postmarket surveillance of drugs."

During the interview, Makary also touched on FDA's recent decision to release complete response letters that detail why regulators refused to approve a drug. Earlier in the week, the agency published more than 200 CRLs, and Makary issued a statement that the decision was part of FDA's commitment to "radical transparency" and to give the public more insight into the agency's decision-making.

"We have thousands of letters that we are redacting, we're going to make them public ... and we're going to be releasing them in real-time, as we make decisions, and that way shareholders will be able to see exactly what the FDA said,” Makary said on Squawk Box.

The Association for Accessible Medicines (AAM) and several dozen other advocacy groups have written to congressional leaders voicing their support for the Biosimilar Red Tape Elimination Act, which would remove certain requirements for biosimilars to be considered interchangeable by FDA. More specifically, it would ensure that approved biosimilars are considered interchangeable with their reference product without requiring manufacturers to provide more evidence. It would also eliminate the exclusivity period for first interchangeable biosimilars.

President Trump issued a memo to department and agency heads earlier this week announcing a hiring freeze until 15 October. He said they are not allowed to fill any presently vacant federal civilian position, nor create new positions with certain exceptions.

Despite the memo, Makary sent a video statement to FDA staff again seen by Focus, stating that he was not part of the decision to fire staff en masse as part of the president’s reduction-in-force (RIF) actions and that there are currently hundreds of job openings at the agency. BioCentury also reported that Vinay Prasad, director of the Center for Biologics Evaluation and Research (CBER), detailed his hiring plans in a memo to staff this week. He said he is making a major recruitment effort, especially for reviewers, and is personally reaching out to staff who have recently left the agency to try persuading them to come back.

The Senate Appropriations Committee unanimously approved its version of FDA's FY 2026 budget that includes $3.6 billion for the agency. It notes that with user fees, the agency's total budget will reach $7 billion, and approximately $200 million more than the appropriations bill pending in the House.

The House Energy and Commerce (E&C) committee's subcommittee on health is scheduled to hold a hearing on 16 July to discuss the Over-the-Counter Monograph User Fee Amendments (OMUFA) program.

Drugs & Biologics

KalVista Pharmaceuticals announced that its drug Ekterly (sebetralstat) has been approved by FDA as the first and only oral on-demand treatment for hereditary angioedema. The announcement is especially significant as there have been recent reports that Makary sought to issue a CRL for the drug after 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.”

The agency also kicked off its user fee reauthorization effort with a public meeting on the Generic Drug User Fee Amendments (GDUFA) program on Friday, which will be followed by a PDUFA reauthorization meeting on Monday.

As part of the Biosimilar User Fee Amendments (BsUFA III), FDA said it is holding a hybrid meeting on 18 September to review the progress of its pilot regulatory science program, which is focusing on advancing the development of interchangeable products and improving biosimilar product development. The agency said it will also use the meeting as an opportunity to get feedback on future priorities.

FDA announced it will also hold a hybrid public scientific workshop the following day on 19 September to discuss the development of interchangeable products as part of its BsUFA III commitment. The agency said that within a year of the workshop it plans to issue a draft strategy document for public comment based on what it learned and then publish a final version of the document within 9 months of the public comments closing.

FDA’s Compounding Quality Center of Excellence announced it will host its sixth annual conference between 25 to 28 August to discuss topics such as current good manufacturing practices (CGMP), mitigating drug shortages, and what to expect during inspections. The meeting is intended for stakeholders such as outsourcing facilities and compounders who want to become outsourcing facilities, state pharmacy regulators, and others.

Medtech

AirLife and its manufacturer, Vyaire, have issued a class I recall for some of their Infant Heated Wire Circuits used during ventilation to warm the air that patients receive after receiving reports that accessory adapters that come with the devices may unintentionally disconnect when the circuits reach operating temperatures. The defective products could lead to patients not receiving sufficient oxygen, which could lead to organ failure or death. However, the companies say they have not had reports of any serious injuries.

Avanos Medical has issued a class I recall for certain Ballard Closed Suction Systems used to remove airway secretions in patients receiving mechanical ventilation due to reports of failures in the sterilization process. The company said the issue could cause infections, airway injuries, prolonged inflammation, sepsis, and death. It noted, however, that it has not received any reports of serious injuries.

This Week at FDA: Makary celebrates first 100 days, Senate committee passes FDA budget bill, and more

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