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

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

Author information

1
Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont Street, Boston, MA 02120, USA.
2
Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 1620 Tremont Street, Boston, MA 02120, USA akesselheim@bwh.harvard.edu.

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.

PMID:
31645328
PMCID:
PMC6812612
DOI:
10.1136/bmj.l5766
[Indexed for MEDLINE]
Free PMC Article

Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at http://www.icmje.org/coi_disclosure.pdf and declare: support from the Open Society Foundations, Arnold Ventures, Engelberg Foundation, and Harvard-MIT Center for Regulatory Science for the submitted work; no financial relationships with any organizations that might have an interest in the submitted work in the previous three years, and no other relationships or activities that could appear to have influenced the submitted work.

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