Public sector financial support for late stage discovery of new drugs in the United States: cohort study

Abstract

Objective: To determine the extent to which late stage development of new drugs relies on support from public funding.

Design: Cohort study.

Setting: All new drugs containing one or more new molecular entities approved by the US Food and Drug Administration (FDA) between January 2008 and December 2017 via the new drug application pathway.

Main outcome measures: Patents or drug development histories documenting late stage research contributions by a public sector research institution or a spin-off company, as well as each drug's regulatory approval pathway and first-in-class designation.

Results: Over the 10 year study period, the FDA approved 248 drugs containing one or more new molecular entities. Of these drugs, 48 (19%) had origins in publicly supported research and development and 14 (6%) originated in companies spun off from a publicly supported research program. Drugs in these groups were more likely to receive expedited FDA approval (68% v 47%, P=0.005) or be designated first in class (45% v 26%, P=0.007), indicating therapeutic importance.

Conclusions: A review of the patents associated with new drugs approved over the past decade indicates that publicly supported research had a major role in the late stage development of at least one in four new drugs, either through direct funding of late stage research or through spin-off companies created from public sector research institutions. These findings could have implications for policy makers in determining fair prices and revenue flows for these products.

Fig 1

Proportion of new drugs with publicly sponsored research or from spin-off companies, identified by data source. The figure shows the breakdown of the relative share of the data sources used to identify publicly supported research contributions. The first four columns represent the drugs identified as having public sponsored research origins, and the last column represents those with spin-off company origins. Most drugs identified as publicly supported research contributions had Orange Book patents assigned to either to a public sector institution (28/62) or spin-off company (an additional 7/62). Two more drugs were primarily identified by Merck Index patents, six by AdisInsight entries, and five by the authors’ investigation of the drug’s history. Finally, 14 drugs were identified as originating in a spin-off company. For the spin-off drugs, 12 had Orange Book patents held by the spin-off company (the remaining two had Orange Book patents held by the successor company of the spin-off). OB=Orange book; MI=Merck Index; AI=AdisInsight; DH=drug history (author’s investigation); SO=spin-off company

Fig 2

Changes in rates of publicly sponsored research contributions to new drug discovery, by study over time with data sources used. The figure compares the present study with previous studies examining public sector contributions to new drug discovery via patent analysis. The Kaitin and DiMasi studies used the Tufts Center for the Study of Drug Development databases that use Orange Book patents as well as other proprietary datasets (not fully described). The analysis by Sampat and Lichtenberg examined patents listed only in the Orange Book. The Stevens et al study examined the Orange Book, proprietary licensing databases, and conducted a survey of university technology transfer managers to identify drugs that originated in public sector institutions. The relative contributions of the various sources were not disclosed, and how the studies dealt with contributions from public sector spin-off companies is not clear. However, the study period for Stevens et al was similar to that of Sampat and Lichtenberg, so the difference between their findings might be a result of the additional sources used. OB=Orange Book