Evidence map›Paper›PMID 40896385›Full record

ArticleHealth affairs scholar2025

Early impact of the Inflation Reduction Act on small molecule vs biologic post-approval oncology trials.

Hanke Zheng, Julie A Patterson, Jonathan D Campbell

Abstract read
In one paragraph

Article in Health affairs scholar, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. The Changing Landscape of Global Biopharmaceutical Leadership, 2004-2024.Therapeutic innovation & regulatory science · 2026
    Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Hanke ZhengResearch Department, National Pharmaceutical Council, Washington, DC 20006, United States.ORCID https://orcid.org/0000-0002-4992-121X
Julie A PattersonResearch Department, National Pharmaceutical Council, Washington, DC 20006, United States.
Jonathan D CampbellResearch Department, National Pharmaceutical Council, Washington, DC 20006, United States.ORCID https://orcid.org/0000-0001-6539-1258

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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). Results: The monthly average of small molecule and biologic trials dropped by 45.3% ( Conclusion: This finding supports hypotheses that the IRA's differential timelines toward DPNP eligibility for the 2 molecule types may disproportionately disincentivize post-approval research in small molecule drugs.

Indexed as

Drug Price Negotiation ProgramInflation Reduction Actoncologypost-approval clinical developmentsmall molecule

Identifiers

PMID40896385
PMCPMC12392883

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.