Workforce Shifts at HHS
A major focus this week has been the continuing fallout from the Trump administration’s reduction-in-force (RIF) initiatives at the Department of Health and Human Services (HHS). According to an investigation by ProPublica, more than 20,500 staff members—or roughly 18% of the department’s workforce—have either been laid off or resigned since January. This includes more than 3,000 scientists, over 1,000 regulators, and numerous public health specialists. The scale of the cuts raises concerns about how well federal agencies can continue to oversee safety, compliance, and research across healthcare sectors.
Updates on the CNPV Pilot
FDA Commissioner Marty Makary provided insight into the Commissioner’s National Priority Voucher (CNPV) pilot program. Speaking on an FDA podcast, Makary said drug divisions have begun nominating products for inclusion, with each division asked to submit up to two candidates. While acknowledging the process may be “a little clunky” at first, Makary emphasized that trying new approaches is essential to ensure the program’s success. The CNPV initiative is designed to incentivize development in areas of high unmet need, offering companies expedited review benefits for select products.
Focus on User Fees and Budget Planning
On September 30, FDA will hold its annual public meeting to discuss user fee programs under the Prescription Drug User Fee Amendments (PDUFA VII), Biosimilar User Fee Amendments (BsUFA III), and Generic Drug User Fee Amendments (GDUFA III). The agency will present five-year financial plans for each program and provide updates on resource capacity planning. These discussions are particularly significant as the agency faces budgetary constraints amid calls for reform and reduction of user fees.
Broader Developments in Healthcare and Policy
In addition to FDA-specific updates, the White House announced that starting September 1, generic drugs and their ingredients imported from the EU will face a “most-favored-nation” tariff rate set near zero. In contrast, branded pharmaceuticals from the EU will carry a 15% base tariff. Meanwhile, President Trump signed an executive order aimed at improving the usability and aesthetics of federal websites, including FDA’s, emphasizing both efficiency and public trust in digital platforms.
Separately, hundreds of current and former HHS employees issued a letter criticizing Secretary Robert F. Kennedy Jr. for rhetoric they believe contributed to an armed attack on the CDC headquarters earlier this month. The letter underscores growing tensions surrounding public health messaging and the politicization of vaccine safety debates.
Drug and Biologics Developments
On the product side, Ionis Pharmaceuticals received FDA approval for Dawnzera (donidalorsen), the first RNA-targeted drug designed to prevent hereditary angioedema (HAE) attacks in patients over 12. FDA also announced upcoming meetings, including the Advancing Generic Drug Development Workshop in October and a two-day patient-focused drug development workshop in September to address methodological challenges in patient experience data.
Additionally, FDA published its 2025 guidance agenda for the Center for Drug Evaluation and Research (CDER), outlining 88 proposed guidance documents. These span areas from ANDA submissions to the adoption of International Council for Harmonisation (ICH) standards. The agency also committed to publishing adverse event data from its reporting system daily, signaling a push for greater transparency and faster public access to safety information.
Conclusion
This week’s developments highlight the complexity of balancing regulatory oversight, workforce challenges, and new initiatives at FDA. From user fee negotiations to pilot programs like the CNPV, regulators are working to adapt to a changing healthcare environment while continuing to approve critical therapies.
At EMMA International, we help life science organizations navigate this evolving landscape by providing expertise in regulatory compliance, quality systems, and strategic planning. Whether it is preparing for FDA user fee impacts, developing strategies for breakthrough therapies, or interpreting new guidance, our team supports clients in staying aligned with regulatory expectations while focusing on patient outcomes.
For more information on how EMMA International can assist, visit www.emmainternational.com. Contact EMMA International at (248) 987-4497 or by email at info@emmainternational.com to learn more.
References
Al-Faruque, F. (2025, August 21). Groups pressure CMS to speed coverage of breakthrough devices after FDA authorization. Regulatory Affairs Professionals Society.
