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

BMJ. 2019 Oct 23;367:l5766. doi: 10.1136/bmj.l5766.

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Clinical Trials as Topic / economics*
  • Clinical Trials as Topic / statistics & numerical data
  • Cohort Studies
  • Drug Approval / economics*
  • Drug Approval / legislation & jurisprudence
  • Drug Approval / statistics & numerical data
  • Humans
  • Patents as Topic / statistics & numerical data
  • Public Sector / economics*
  • Public Sector / statistics & numerical data
  • Translational Medical Research / economics*
  • Translational Medical Research / statistics & numerical data
  • United States
  • United States Food and Drug Administration / legislation & jurisprudence
  • United States Food and Drug Administration / statistics & numerical data