The United States leads the world in the discovery and development of innovative medicines, thanks largely to a regulatory system that enables timely, science-based reviews of new drugs. A critical pillar of that system is the Prescription Drug User Fee Act (PDUFA)—a policy that has accelerated the pace at which safe, effective treatments reach American patients, with industry funding a significant portion of FDA drug review costs. Yet today, PDUFA’s future, and the future of timely drug approval itself, is at risk due to potential budgetary cuts that would trigger returns of PDUFA funds, critically undermining the Food and Drug Administration’s (FDA) ability to fulfill its mission.

PDUFA’s Impact

Enacted in 1992, PDUFA allows the FDA to collect user fees from pharmaceutical companies to help fund the new drug review process. Congress passed the bipartisan legislation to reduce the time and cost of drug development and to support innovation by incorporating the latest advances in regulatory science into drug review. PDUFA, which must be reauthorized every five years, was most recently renewed in 2022, with the current reauthorization effective through 2027.

Before PDUFA, understaffing and underfunding at the FDA contributed to long review times, delaying patient access to new therapies. PDUFA enabled the FDA to hire additional scientific and medical reviewers, modernize its systems, and create a more efficient drug review process.

In the years following the enactment of PDUFA, average drug approval times declined by about 42 percent—from 24.2 months in 1991 to 14.2 months in 2002. Roughly two-thirds of this reduction can be attributed directly to the law, and most of the decline occurred during the early years of PDUFA implementation (1992–1997). Approval times have since fallen further, to approximately 10 months—all without compromising drug safety.

Moreover, since the enactment of PDUFA, the United States has become the leading market for first drug launches, ensuring that American patients gain earlier access to life-saving therapies than patients in many other countries. In 2024, 68 percent of novel drugs approved by the FDA received their first approval in the United States. This faster, more reliable FDA review process has helped cement America’s position as the global leader in biopharmaceutical innovation.

Finally, improved regulatory timelines help sustain private sector investment in costly, risky drug research and development (R&D). With development timelines exceeding a decade and costs reaching billions of dollars, reducing regulatory uncertainty is essential to attract and maintain investment in innovative therapies.

Policy Threats to Continued Success

Despite PDUFA’s achievements, policy shifts under the Trump administration have raised serious concerns about the future of drug development in the United States. Proposed budget and staffing cuts at the FDA threaten to slow drug research and review, undermining the agency’s capacity for critical regulatory and oversight functions. As part of a broader restructuring within the Department of Health and Human Services (HHS), 3,500 FDA positions—nearly 20 percent of its workforce—have been eliminated, risking significant disruptions to drug review, safety monitoring, and other essential agency functions.

While PDUFA fees account for roughly 70 percent of the FDA’s funding for drug review, these user fees are intended to supplement—not replace—congressional appropriations. Recent FDA cuts jeopardize this balance. PDUFA includes a “trigger mechanism” requiring congressional appropriations to remain above a threshold set in 1997 (adjusted for inflation). If funding drops below that level, the FDA must return collected user fees, severely hampering its ability to conduct timely drug reviews. The Trump administration’s reductions risk triggering this mechanism, threatening to reverse decades of progress and delay access to potentially life-saving therapies. To safeguard drug innovation and ensure timely patient access, it is critical to preserve the user fee framework and maintain robust congressional support.

Why Policymakers Should Act

For over 30 years, PDUFA has helped align FDA resources with the increasing complexity of drug development. PDUFA ensures the agency can keep pace with scientific advances—from gene therapies to targeted biologics—while upholding rigorous safety and efficacy standards. Undermining this framework through budget cuts or failure to reauthorize user fee legislation would jeopardize U.S. biopharmaceutical leadership and delay patient access to novel therapies.

To sustain biopharmaceutical innovation and ensure patients benefit from cutting-edge science, preserving and strengthening the PDUFA framework must remain a top policy priority. Congress should provide stable, robust funding that enables the FDA to fulfill its critical public health mission and support the next generation of medical breakthroughs.