Public Support for Late-Stage New Drug Discovery

Abstract

Objective: To determine the role of publicly-supported research in the development of innovative new medications. Design: We examined patent data and drug discovery and development histories to assess the extent of public support for late-stage medication development. Setting: All new drugs approved containing one or more new molecular entity 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 history documenting late-stage research contributions by publicly funding to an academic center or closely related a spin-off company, as well as each drug’s approval pathway and first-in-class designation. Results: Over the 10-year study period, the FDA approved 248 novel drugs containing one or more new molecular entities. We found that 62 (25%) of these drugs were based at least in part on patents or other late-stage intellectual contributions by publicly-supported research. 48 drugs (19%) had origins in publicly-supported research and development and 14 (6%) originated in in companies spun-off from a publicly-supported research program. Drugs with public-sector provenance were more likely to receive an expediated FDA approval or be designated first-in-class, indicating their relative therapeutic importance. Conclusions: A review of the patents associated with new drugs approved over the last decade indicates that publicly-supported research played a major role in the development of a substantial proportion of new medications, either through direct funding of late-stage research or the creation of resultant spin-off companies. This may have implications for policy makers in determining fair prices and revenue flows for these products.