Category Ranking
98%
Total Visits
921
Avg Visit Duration
2 minutes
Citations
20
Article Abstract
Background: The 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.
Methods: Using 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.
Results: Following 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.
Conclusions: The 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.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC12181196 | PMC |
| http://dx.doi.org/10.1007/s43441-025-00774-2 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
The prospect of approved and commercially available phage therapeutics.
Int J Antimicrob Agents
September 2025
Institute for Technology Assessment and Systems Analysis (ITAS), Karlsruhe Institute of Technology, P.O. Box 3640, 76021 Karlsruhe, Germany. Electronic address:
As antibiotic resistance of bacterial pathogens spreads, interest in bacteriophage (phage) therapy has soared again in many countries. Currently, there is no phage therapeutic with marketing approval and phage treatments are relegated to few patients, mostly under compassionate use schemes when approved drugs failed or are unavailable. Commercially manufactured and approved phage preparations could both expand the availability of therapeutic phages for existing, exemptional treatment schemes and result in more broadly usable phage therapeutics with marketing authorization.
View Article and Find Full Text PDFStructural and Functional Determinants of ARIA-H Risk in Anti-Amyloid Monoclonal Antibodies: A Comparative Mechanistic Framework for Alzheimer's Immunotherapy Development.
Curr Neuropharmacol
August 2025
Department of Neurology, Nanjing Drum Tower Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Nanjing, China.
Introduction: Amyloid-beta-targeting monoclonal antibodies (mAbs) for Alzheimer's disease frequently induce amyloid-related imaging abnormalities with hemorrhage (ARIA-H), yet systematic comparisons of ARIA-H incidence across therapeutic agents remain limited. Post-approval research prioritizes dosing over mechanism, leaving unresolved whether ARIA-H variations originate from intrinsic mAb properties. We address two gaps: comparative ARIA-H risk stratification among clinically available/investigational mAbs, and elucidation of structural/functional features influencing ARIA-H susceptibility.
View Article and Find Full Text PDFThe Impact of the Inflation Reduction Act's Drug Price Negotiation Program on Incentives for Clinical Development of New Drugs.
Value Health
September 2025
Analysis Group, USA, MA, Boston.
Objectives: We explore the impact of the Drug Price Negotiation Program (DPNP) on investment incentives for drug research and development (R&D).
Methods: We model five hypothetical scenarios of future drugs selected for DPNP. Scenarios defined by disease area, post-approval development strategy, and potential responses to the DPNP, such as delaying, resequencing, or canceling additional indications.
Adverse events of pexidartinib for the treatment of TGCT: a real-world disproportionality analysis using FDA Adverse Event Reporting System database.
Front Oncol
August 2025
Department of Pharmacy, Pingtan Comprehensive Experimental Area Hospital, Fuzhou, China.
Introduction: Pexidartinib, an oral selective colony-stimulating factor 1 receptor (CSF1R) inhibitor, is the only systemic therapy approved by the U.S. Food and Drug Administration (FDA) for tenosynovial giant cell tumor (TGCT).
View Article and Find Full Text PDFEarly impact of the Inflation Reduction Act on small molecule vs biologic post-approval oncology trials.
Health Aff Sch
August 2025
Research Department, National Pharmaceutical Council, Washington, DC 20006, United States.
Introduction: Under the Inflation Reduction Act (IRA), small molecule drugs are subject to a shorter timeline toward eligibility for selection to the Drug Price Negotiation Program (DPNP) than biologics (7 vs 11 years post-approval), raising concerns about incentives for post-approval clinical development.
Methods: Using Citeline's Trialtrove database (7/2014-8/2024), this longitudinal study explored the impact of IRA's passage on industry-sponsored, post-approval phase I-III clinical trials in small molecule vs biologic oncology drugs, excluding vaccine-related trials. We used a difference-in-difference design to explore the impact of the IRA's differential DPNP timeline on small molecule trials in oncology by comparing changes in the number of newly initiated post-approval trials in small molecule drugs after the IRA (first difference) with changes in biological trials (second difference).