ArticleTherapeutic innovation & regulatory science2025
The Inflation Reduction Act and Drug Development: Potential Early Signals of Impact on Post-Approval Clinical Trials.
Article in Therapeutic innovation & regulatory science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
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Who cites it
7 citing papers in PubMed.
- Bridging the divide between health economics and outcomes research and biomedical investment: reflections from a health economist working in venture capital.Journal of comparative effectiveness research · 2026Review
- The Changing Landscape of Global Biopharmaceutical Leadership, 2004-2024.Therapeutic innovation & regulatory science · 2026Article
- Cost-effectiveness thresholds used in the United States vs most favored nations.Health affairs scholar · 2026Article
- Understanding biopharmaceutical investment decision-making: how does Congressional Budget Office's model compare to investor insights?Health affairs scholar · 2025Article
- How much do ex-US revenues make a difference for pharmaceutical investment returns?Journal of comparative effectiveness research · 2025Article
- Early impact of the Inflation Reduction Act on small molecule vs biologic post-approval oncology trials.Health affairs scholar · 2025Article
- The Inflation Reduction Act's Impact Upon Early-Stage Venture Capital Investments.Therapeutic innovation & regulatory science · 2025Article
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Authors and funding
3 authors.
Funding
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Abstract
backgroundThe Inflation Reduction Act's (IRA) Drug Price Negotiation Program (DPNP) may reduce incentives for industry investments in post-approval clinical development. We aimed to explore the IRA's impact on the initiation of industry-sponsored, post-approval clinical trials.
methodsUsing Citeline's Trialtrove database (7/2014-8/2024), we conducted an interrupted time series analysis (ITSA) to estimate the IRA's impact on the initiation of industry-sponsored Phase I-III trials in previously approved drugs, excluding all vaccines and COVID-19 treatments. We conducted an additional ITSA to examine post-IRA changes in government-funded trials, hypothesized to be unaffected by the IRA, and sensitivity analyses to explore potential exogenous confounding factors. Finally, we explored differences in the IRA's impact on post-approval industry-sponsored clinical trial initiation in small versus large molecule drugs.
resultsFollowing the IRA's passage, the average monthly number of industry-sponsored trials on post-approval drugs decreased by 38.4%. The ITSA indicated that the IRA's passage was associated with an immediate drop of 11.1 industry-sponsored trials (p-value < 0.05) and an additional decrease by 0.9 trials per month (p-value < 0.01). The IRA's passage was not statistically associated with changes in government-funded trial initiation. Sensitivity analyses supported ITSA findings. Initiation of post-approval industry-sponsored trials decreased by 47.3% and 32.9% for small and large molecule drugs, respectively.
conclusionsThe IRA's passage was associated with reductions in industry-sponsored, but not government-funded, post-approval trials, with larger reductions for small molecule drugs. These findings provide early evidence supporting concerns around IRA-related reductions in incentives for post-approval clinical development.
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