This Week at FDA: Investigation reveals extent of HHS RIFs, Makary updates on CNPV pilot, FDA to hold meeting on user fees

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, a new analysis showed the extent of the Trump administration’s reduction-in-force (RIF) initiatives, FDA Commissioner Marty Makary said the agency is reviewing products for the Commissioner’s National Priority Voucher (CNPV) pilot program, and FDA announced a meeting to discuss its user fee programs for drugs, biosimilars, and generics.

It's been challenging to know the number of employees fired from HHS since the Trump administration began mass layoffs as part of its reduction-in-force (RIF) initiatives, but analysis from ProPublica shows that the cuts are deeper than the administration has reported. The publication said over 3,000 scientists and public health specialists have left HHS since the administration took control, and more than 1,000 regulators and safety inspectors have exited. In total, it estimates more than 20,500 staff or about 18% of the workforce at the Health and Human Services (HHS) department have either been fired or left since January.

On an FDA podcast, Makary said the agency has been reviewing applications for the CNPV pilot program and asked staff in its drug divisions to submit products they think should be included in the pilot. "We told them they could submit two in this initial round if they feel like there's a tie [between two products]," he added. "We're going to need to hammer some stuff out; it may be a little clunky. We're sort of creating a new process, but we've got to try new things."

On 30 September, FDA will hold its annual public meeting to discuss performance metrics that it has agreed to meet under the Prescription Drug User Fee Amendment (PDUFA VII), Biosimilar User Fee Amendment (BsUFA III), and Generic Drug User Fee Amendment (GDUFA III). The agency plans to present its 5-year financial plans for the programs and give an update on efforts to implement resource capacity planning.

The University of Southern California (USC) will host a hybrid meeting on 19 September to discuss reforming FDA. The speakers include former FDA Commissioner Scott Gottlieb, former FDA Acting Commissioner Janet Woodcock, and former FDA Acting Chief Counsel Lowell Schiller.

Hundreds of current and former HHS employees have signed a letter to Secretary Robert Kennedy Jr. and members of Congress accusing Kennedy of being complicit in the 8 August attack on the Centers for Disease Control and Prevention (CDC) headquarters in Atlanta by a gunman who believed the COVID-19 vaccine had injured him. More specifically, they accused Kennedy of sowing public mistrust in the CDC, falsely claiming that mRNA vaccines were not effective in the COVID-19 pandemic, and falsely claiming that the measles vaccine had not been safety tested.

"The attacker fired hundreds of rounds into buildings as the CDC workforce inside carried out its mission of serving the American people," said the signatories. "The attack came amid growing mistrust in public institutions, driven by politicized rhetoric that has turned public health professionals from trusted experts into targets of villainization—and now, violence."

Fierce Pharma reported that the White House plans to impose a most-favored-nation (MFN) tariff rate on generic drugs, including their active ingredients and chemical precursors, imported from the EU starting 1 September. According to a White House statement, that rate will effectively be zero or close to zero. Branded pharmaceuticals from the EU will be subject to a base tariff of 15%, according to the statement.

President Trump issued an executive order on 21 August to improve the usability and aesthetics of governmental websites, such as FDA's. "It is the policy of my Administration to deliver digital and physical experiences that are both beautiful and efficient, improving the quality of life for our Nation," said Trump in a statement. "Towards that end, the National Design Studio will advise agencies on how to reduce duplicative design costs, use standardized design to enhance the public’s trust in high-impact service providers, and dramatically improve the quality of experiences offered to the American public."

Drugs & Biologics

Ionis Pharmaceuticals announced that FDA has approved Dawnzera (donidalorsen) to prevent attacks of the rare and genetic disease hereditary angioedema (HAE) in people over 12. The company said it is the first and only RNA-targeted drug approved for HAE and intended to target plasma prekallikrein (PKK) associated with acute HAE attacks.

FDA is hosting a two-day meeting entitled the 2025 Advancing Generic Drug Development Workshop on 7 October to discuss the impact of its Generic Drug User Fee Amendments (GDUFA III) Science and Research Program on generic drug development. Regulators will discuss issues such as abbreviated new drug applications (ANDA), pre-ANDA, and ANDA meetings.

Fierce Pharma reported that FDA has extended its target action dates for two expanded use applications for Regeneron's Eylea HD (aflibercept) due to concerns about its third-party manufacturer. The company had applied for approval for a Chemistry, Manufacturing and Controls (CMC) Prior-Approval Supplement (PAS) for the Eylea HD prefilled syringe and a supplemental Biologics License Application (sBLA) to treat macular edema following retinal vein occlusion.

As part of its series of workshops on patient-focused drug development, the FDA announced it will host a two-day virtual meeting starting 18 September to discuss methodological challenges related to patient experience data. Among the topics, the agency plans to address submission and evaluation of patient experience data in the context of the benefit-risk assessment and product labeling.

On 30 September, the FDA will host a public hybrid meeting to discuss its proposed PreCheck program, which aims to establish new domestic drug and biologics manufacturing facilities in the US to boost the pharmaceutical supply chain. More specifically, the agency wants public feedback on regulatory hurdles to establishing new domestic drug manufacturing facilities, what elements of the PreCheck program are likely to help domestic manufacturing, what information companies would be willing to share for the program separate from an application submission, and what concerns they have about sharing such information.

FDA published a list of guidances it wants to develop for the Center for Drug Evaluation and Research (CDER) during calendar year 2025. It includes 88 proposed guidances that cover topics including generic ANDA submissions, adopting ICH guidelines, and compounding drugs.

FDA also announced it will publish adverse event data from its Adverse Event Reporting System (FAERS) daily in what the agency calls "its commitment to radical transparency and real-time protection of public health."

“Adverse event reporting should be fast, seamless and transparent,” Makary said in a statement. “People who navigate the government’s clunky adverse event reporting websites should not have to wait months for that information to become public. We’re closing that waiting period and will continue to streamline the process from start to finish.”

This Week at FDA: Investigation reveals extent of HHS RIFs, Makary updates on CNPV pilot, FDA to hold meeting on user fees

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