国会预算办公室-美国国立卫生研究院资金的变化和美国食品药品监督管理局审查时间的变化将如何影响新药的开发（英）-2025.7_10页_524kb

Summary of Congressional Budget Office Analysis on NIH Funding and FDA Review Times Effects on New Drug Development

The Congressional Budget Office (CBO) analyzed two hypothetical scenarios: a permanent 10% reduction in NIH funding and a nine-month increase in FDA review times for new drug applications. The effects were evaluated on new drug development.

For a 10% reduction in NIH funding targeted at external preclinical research, CBO estimated a gradual decrease in new drug approvals, reducing the total number by approximately 4.5% over a 30-year period, equivalent to about 1-2 drugs per year in early years, growing to 20 fewer drugs later. CBO did not quantify the effects of reducing other NIH funding components. A larger reduction (35-38%) was not assessed due to uncertainty.

A nine-month increase in FDA review times initially delayed drug approvals by shifting submissions to the next year, but the primary long-term effect was increased development costs. This could reduce new drug approvals by about 2% annually in the second decade, equivalent to 1 fewer drug per year initially, increasing to 10 fewer in later decades. CBO did not analyze how reduced expected revenues or other stakeholder behaviors would influence outcomes.

The analysis highlighted uncertainties, including the impact of un-funded research projects and implementation details. CBO plans to update its drug development model based on user feedback.

The effects stem from NIH funding's role in preclinical research and clinical trials, and FDA reviews in drug market entry and financing.