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

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 20...

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Autores principales: Nayak, Rahul K, Avorn, Jerry, Kesselheim, Aaron S
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group Ltd. 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6812612/
https://www.ncbi.nlm.nih.gov/pubmed/31645328
http://dx.doi.org/10.1136/bmj.l5766
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author Nayak, Rahul K
Avorn, Jerry
Kesselheim, Aaron S
author_facet Nayak, Rahul K
Avorn, Jerry
Kesselheim, Aaron S
author_sort Nayak, Rahul K
collection PubMed
description 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.
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spelling pubmed-68126122019-11-08 Public sector financial support for late stage discovery of new drugs in the United States: cohort study Nayak, Rahul K Avorn, Jerry Kesselheim, Aaron S BMJ Research 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. BMJ Publishing Group Ltd. 2019-10-23 /pmc/articles/PMC6812612/ /pubmed/31645328 http://dx.doi.org/10.1136/bmj.l5766 Text en Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
spellingShingle Research
Nayak, Rahul K
Avorn, Jerry
Kesselheim, Aaron S
Public sector financial support for late stage discovery of new drugs in the United States: cohort study
title Public sector financial support for late stage discovery of new drugs in the United States: cohort study
title_full Public sector financial support for late stage discovery of new drugs in the United States: cohort study
title_fullStr Public sector financial support for late stage discovery of new drugs in the United States: cohort study
title_full_unstemmed Public sector financial support for late stage discovery of new drugs in the United States: cohort study
title_short Public sector financial support for late stage discovery of new drugs in the United States: cohort study
title_sort public sector financial support for late stage discovery of new drugs in the united states: cohort study
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6812612/
https://www.ncbi.nlm.nih.gov/pubmed/31645328
http://dx.doi.org/10.1136/bmj.l5766
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