The Current FDA Landscape
Recent weeks have brought significant changes to the Department of Health and Human Services (HHS), including the regulatory bodies we deal with including the US Food & Drug Administration (FDA) and US Environmental Protection Agency (EPA) . As reported widely in industry publications, HHS Secretary Robert F. Kennedy Jr. has announced substantial staff reductions—approximately 3,500 positions at the FDA alone—as part of broader cuts across federal health agencies. These reductions have not only impacted leadership positions but also affected critical support functions that maintain the infrastructure of the review process for human and veterinary drugs, biological products, and medical devices. Similar anticipated cuts at FDA are expected to impact the registration of a wide array of consumer products that impact public health, such as air sanitizers.
Former FDA Commissioner Janet Woodcock characterized these developments as “a slow-moving catastrophe,” comparing them to “retaining only doctors at a hospital, while letting go of all nurses and phlebotomists.” As she noted, “Doctors can’t just walk in and perform surgery all by themselves…The reviewer is the same.” This aptly captures how the complex ecosystem of regulatory review depends on multiple roles beyond just the primary reviewers.
Industry publications have also reported concerns about potential disruptions to drug review timelines, user fee programs, and essential services. The Prescription Drug User Fee Act (PDUFA) program, which has been foundational to FDA’s ability to conduct timely reviews since 1992, may face particular challenges as many of the FDA’s staff involved in user fee negotiations were among those swept up in the staff reductions. Already, we’ve seen missed deadlines, such as the FDA’s decision on Novavax’s COVID-19 vaccine approval, which may signal emerging process challenges.
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