Contribution of NIH funding to new drug approvals 2010-2016

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.

Keywords: NIH funding; basic science; drug development; translational science.

Fig. 1.

PMIDs, NIH-funded PMIDs, NIH funding year, and costs associated with 210 NMEs approved from 2010–2016 or the 151 known molecular targets for these NMEs. (A) PMIDs identified searching for NMEs (drug search) or their molecular targets (target search). (B) PMIDs associated with NIH funding in RePORTER (1980–present). (C) Funding years associated with NIH-funded PMIDs directly related to NMEs (drug) or their targets (target only). (D) Project costs (2000–2016) associated with funding years (all), costs directly related to the NMEs (drug), or costs related to the molecular target only (target only). Open circles indicate years of supplemental funding from the ARRA. Dashed line shows trend without ARRA data. Shaded areas show the years of drug approvals.

Fig. 2.

NIH funding years associated with research on first-in-class products (2010–2016). Data are normalized to the year of first FDA approval. (A) Funding years directly related to NMEs (drug) or their molecular target (target). Data are shown for research leading to first-in-class NMEs discovered by targeted or phenotypic methods. (B) Ratio of funding years directly related to drugs or targets for first-in-class NMEs discovered by targeted or phenotypic methods. Data after the year of first approval are shown as dashed lines. (C) Timeline of funding years related to the NME (drug, targeted) or the molecular target (target, targeted) for first-in-class drugs discovered by targeted screening. (D) Timeline of funding years related to the NME (drug, phenotypic) or the molecular target (target, phenotypic) for first-in-class drugs discovered with phenotypic methods.