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Changes in evidence used for FDA Novel Drug Approvals: 2016-2024

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  • Aditya Narayan
  • Veronica L Irvin
  • Amanda J Koong
  • Sujin Song
  • Robert M Kaplan

Abstract

Background: The 21st Century Cures Act (2017) was enacted during a period of evolving FDA flexibility in evidentiary standards for drug approval. To examine trends before and after implementation, we independently reviewed all novel drugs approved between 2016 and 2024. Methods: We constructed a database of all novel FDA approvals from January 1, 2016, through December 31, 2024. Each study linked to an approved drug (N = 6,763) was cataloged by study number, sponsorship, and timing of results reporting relative to completion. Results: Since 2016, the number of studies supporting approval has steadily declined. Beginning in 2017, the modal number of studies per approval fell to one. Industry sponsorship increased while NIH-supported studies decreased. Average time to public posting of results exceeded the one-year statutory limit. Conclusions: In the post-2016 period, FDA approvals were supported by fewer studies and by a greater proportion of industry-sponsored studies. Although this may accelerate access to new therapies, it raises concerns about the strength of evidence for safety and effectiveness.

Suggested Citation

  • Aditya Narayan & Veronica L Irvin & Amanda J Koong & Sujin Song & Robert M Kaplan, 2026. "Changes in evidence used for FDA Novel Drug Approvals: 2016-2024," PLOS ONE, Public Library of Science, vol. 21(8), pages 1-11, August.
    • Handle: RePEc:plo:pone00:0342878
    DOI: 10.1371/journal.pone.0342878
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