Bush signs Prescription Drug User Fee Act, shifting FDA review costs to pharmaceutical industry

President George H.W. Bush signed the Prescription Drug User Fee Act (PDUFA) on October 29, 1992, authorizing the FDA to collect fees from pharmaceutical manufacturers to fund drug review. The law was designed to cut median drug review times — then averaging 30 months — by hiring hundreds of additional reviewers. A core accelerated approval pathway was also codified, allowing drugs for serious conditions to gain approval based on surrogate endpoints rather than clinical outcomes. PDUFA created a structural financial dependency: by fiscal year 2026, industry user fees totaled $1.43 billion, funding 65 percent of the FDA's drug review budget.