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# FDA Reform Requires a ‘Whole-of-System’ Strategy: Editorial
- URL: https://www.fdaweb.com/fda-reform-requires-a-whole-of-system-strategy-editorial/
- Published: 2026-07-21T12:00:00.000Z
- Updated: 2026-09-14T13:43:22.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5161493

To be successful, FDA reform should involve a whole-of-system strategy centered on predictable, inflation-adjusted funding, protection of workforce memory, and renewed engagement with global regulatory and public health networks. That’s the view of a *Cureus Journal of Medical Science* [editorial](https://www.cureus.com/articles/513230-making-the-fda-great-again-requires-rebuilding-americas-scientific-infrastructure?ref=fdaweb.com#!/) written by **Arya Babul** and **Parisa Mahdavi**.

The two suggest that “FDA’s fragility is not an isolated political phenomenon; it reflects a broader, self-inflicted weakening of U.S. scientific and regulatory capacity across the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), the United States Agency for International Development (USAID), and global health partnerships. At the same time, China’s rapid ascent in pharmaceutical innovation is structural, not merely geopolitical, and U.S. institutional erosion accelerates this shift.”

Babul and Mahdavi say FDA’s challenges cannot be addressed only through leadership changes. Rather, they say, the agency’s ability to function as a scientific institution depends on the strength of the broader ecosystem that surrounds it. “Domestic erosion across this ecosystem is the primary driver of FDA’s current vulnerability,” they write, “and its effects are visible across every stage of the biomedical pipeline.”

They say that restoring FDA’s role as the global regulator of reference requires a whole-of-system strategy that strengthens the scientific institutions surrounding it. “FDA does not operate in isolation; its regulatory judgments depend on the stability and quality of upstream scientific inputs,” they write. “Rebuilding U.S. biomedical leadership, therefore, begins with restoring predictable, sustained NIH funding to support early‑stage discovery, translational research, and clinical trials. Without a strong NIH, FDA’s evidentiary foundation erodes. Equally essential is revitalizing the CDC’s surveillance capacity, which provides the real-world safety signals, epidemiologic data, and population-level insights that inform FDA decision-making. A regulator cannot be strong if its national surveillance backbone is weak.”

The authors also call for reinvestment that extends beyond domestic agencies. USAID field sites, global health programs, and partnerships with the World Health Organization (WHO) have historically supplied FDA with trusted international data, regulatory harmonization pathways, and collaborative networks that validate foreign clinical evidence, they say. Rebuilding these partnerships is critical for maintaining U.S. credibility in global regulatory science. Finally, the editorial contends that protecting institutional memory across all the agencies is indispensable. “Workforce departures at FDA, NIH, CDC, and USAID have not only reduced headcount but have also depleted tacit knowledge, including the operational know-how, informal problem-solving practices, and accumulated experience that make regulatory systems resilient,” the authors say. “Strengthening FDA Center leadership is necessary, but it will be insufficient unless accompanied by broader investments in scientific capacity, surveillance infrastructure, global engagement, and the preservation of institutional memory. Only a coordinated, whole-of-system approach can restore the scientific and regulatory foundations that once made U.S. biomedical leadership possible. Key elements include restoring predictable, inflation-adjusted, long-term funding; instituting comprehensive debriefing protocols and operational problem-solving logs from departing senior scientists; replacing outdated regulatory structures that inflate costs and elongate clinical trial timelines with streamlined, rapid-translation pathways and increased federal proof-of-concept funding; and immediate re-funding of closed USAID international field sites alongside formal re-engagement with WHO harmonization networks.