Regulatory Reliance and the Politics of Pharmaceutical Governance.

Abstract

The US Food and Drug Administration (FDA) has long served as a credibility reference for dozens of countries that incorporate its assessments into their own drug authorization processes. I argue that regulatory reliance is a governance mechanism through which the reputational capital of a few anchor agencies shapes pharmaceutical regulation worldwide. For reliance to work, anchor agencies must maintain credibility and independence sufficient to make their assessments worth borrowing, and domestic regulators need enough autonomy to invoke external assessments as constraints on domestic political pressure. Drawing on Carpenter's reputational concept, the political economy literature on regulatory agency design, and evidence from Latin America, the Asia-Pacific, and Africa, my analysis documents the architecture of reliance and its concentration in a few agencies. During the COVID-19 pandemic, Brazil's regulator grounded its emergency procedures in FDA and European Medicines Agency standards to resist domestic pressure, whereas India's regulator authorized vaccines before any reference authority had acted. Workforce reductions, compressed timelines, and weakened evidentiary standards at the FDA now threaten this architecture. Countries that had no part in this erosion are likely to bear its consequences. (<i>Am J Public Health</i>. Published online ahead of print June 25, 2026:e1-e7. https://doi.org/10.2105/AJPH.2026.308597).