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Contribution of NIH funding to new drug approvals 2010–2016

Author

Listed:
  • Ekaterina Galkina Cleary

    (Center for Integration of Science and Industry, Bentley University, Waltham, MA 02452)

  • Jennifer M. Beierlein

    (Center for Integration of Science and Industry, Bentley University, Waltham, MA 02452; Department of Natural and Applied Sciences, Bentley University, Waltham, MA 02452)

  • Navleen Surjit Khanuja

    (Center for Integration of Science and Industry, Bentley University, Waltham, MA 02452)

  • Laura M. McNamee

    (Center for Integration of Science and Industry, Bentley University, Waltham, MA 02452; Department of Natural and Applied Sciences, Bentley University, Waltham, MA 02452)

  • Fred D. Ledley

    (Center for Integration of Science and Industry, Bentley University, Waltham, MA 02452; Department of Natural and Applied Sciences, Bentley University, Waltham, MA 02452; Department of Management, Bentley University, Waltham, MA 02452)

Abstract

This work examines the contribution of NIH funding to published research associated with 210 new molecular entities (NMEs) approved by the Food and Drug Administration from 2010–2016. We identified >2 million publications in PubMed related to the 210 NMEs ( n = 131,092) or their 151 known biological targets ( n = 1,966,281). Of these, >600,000 (29%) were associated with NIH-funded projects in RePORTER. This funding included >200,000 fiscal years of NIH project support (1985–2016) and project costs >$100 billion (2000–2016), representing ∼20% of the NIH budget over this period. NIH funding contributed to every one of the NMEs approved from 2010–2016 and was focused primarily on the drug targets rather than on the NMEs themselves. There were 84 first-in-class products approved in this interval, associated with >$64 billion of NIH-funded projects. The percentage of fiscal years of project funding identified through target searches, but not drug searches, was greater for NMEs discovered through targeted screening than through phenotypic methods (95% versus 82%). For targeted NMEs, funding related to targets preceded funding related to the NMEs, consistent with the expectation that basic research provides validated targets for targeted screening. This analysis, which captures basic research on biological targets as well as applied research on NMEs, suggests that the NIH contribution to research associated with new drug approvals is greater than previously appreciated and highlights the risk of reducing federal funding for basic biomedical research.

Suggested Citation

  • Ekaterina Galkina Cleary & Jennifer M. Beierlein & Navleen Surjit Khanuja & Laura M. McNamee & Fred D. Ledley, 2018. "Contribution of NIH funding to new drug approvals 2010–2016," Proceedings of the National Academy of Sciences, Proceedings of the National Academy of Sciences, vol. 115(10), pages 2329-2334, March.
    • Handle: RePEc:nas:journl:v:115:y:2018:p:2329-2334
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    Cited by:

    1. Dosi, Giovanni & Palagi, Elisa & Roventini, Andrea & Russo, Emanuele, 2023. "Do patents really foster innovation in the pharmaceutical sector? Results from an evolutionary, agent-based model," Journal of Economic Behavior & Organization, Elsevier, vol. 212(C), pages 564-589.
    2. Dosi, Giovanni & Marengo, Luigi & Staccioli, Jacopo & Virgillito, Maria Enrica, 2023. "Big Pharma and monopoly capitalism: A long-term view," Structural Change and Economic Dynamics, Elsevier, vol. 65(C), pages 15-35.
    3. Fiori, Giovana Maria Lanchoti & Basso, Fernanda Gisele & Porto, Geciane Silveira, 2022. "Cooperation in R&D in the pharmaceutical industry: Technological and clinical trial networks in oncology," Technological Forecasting and Social Change, Elsevier, vol. 176(C).
    4. Castelnovo, Paolo, 2022. "Innovation in private and state-owned enterprises: A cross-industry analysis of patenting activity," Structural Change and Economic Dynamics, Elsevier, vol. 62(C), pages 98-113.
    5. B Ian Hutchins & Matthew T Davis & Rebecca A Meseroll & George M Santangelo, 2019. "Predicting translational progress in biomedical research," PLOS Biology, Public Library of Science, vol. 17(10), pages 1-25, October.

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