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Association between expedited review designations and the US or global burden of disease for drugs approved by the US Food and Drug Administration, 2010–2019: a cross-sectional analysis

BMJ open, 2024-03, Vol.14 (3), p.e076542-e076542 [Peer Reviewed Journal]

Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. ;2024 Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ 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, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. ;Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. 2024 ;ISSN: 2044-6055 ;EISSN: 2044-6055 ;DOI: 10.1136/bmjopen-2023-076542 ;PMID: 38471684

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  • Title:
    Association between expedited review designations and the US or global burden of disease for drugs approved by the US Food and Drug Administration, 2010–2019: a cross-sectional analysis
  • Author: Jackson, Matthew J ; Vaughan, Gregory ; Ledley, Fred D
  • Subjects: Annual reports ; Biological products ; Cross-Sectional Studies ; Disabled Persons ; Drugs ; Estimates ; FDA approval ; Federal regulation ; Global Burden of Disease ; Global Health ; Health policy ; Humans ; Infectious diseases ; Pediatrics ; Pharmaceutical industry ; Pharmaceutical Preparations ; Product development ; PUBLIC HEALTH ; Quality of Life ; Quality-Adjusted Life Years ; Regression analysis ; Tropical diseases ; Tumors ; United States ; United States Food and Drug Administration ; Vaccines
  • Is Part Of: BMJ open, 2024-03, Vol.14 (3), p.e076542-e076542
  • Description: ObjectivesPharmaceutical innovation can contribute to reducing the burden of disease in human populations. This research asks whether products approved by the US Food and Drug Administration (FDA) from 2010 to 2019 and expedited review programmes incentivising development of products for serious disease were aligned with the US or global burden of disease.DesignCross-sectional study.Outcome measuresAssociation of FDA product approvals (2010–2019), first approved indications, designations for expedited review with the burden of disease (disability-adjusted life years (DALYs)), years of life lost (YLL) and years of life lived with disability (YLD) for 122 WHO Global Health Estimates (GHE) conditions in US and global (ex-US) populations.ResultsThe FDA approved 387 drugs in 2010–2019 with lead indications associated with 59/122 GHE conditions. Conditions with at least one new drug had greater US DALYs (p=0.001), US YLL (p<0.001), global DALYs (p=0.030) and global YLL (p=0.004) but not US YLD (p=0.158) or global YLD (p=0.676). Most approvals were for conditions in the top quartile of US DALYs or YLL, but <27% were for conditions in the top quartile of global DALYs or YLL. The likelihood of a drug having one or more designations for expedited review programmes was negatively associated (OR<1) with US DALYs, US YLD and global YLD. There was a weak negative association with global DALYs and a weak positive association (OR>1) with US and global YLL.ConclusionsFDA drug approvals from 2010 to 2019 were more strongly aligned with US than global disease burden. Designations for expedited review were not aligned with either the US or global burdens of disease and may inadvertently disincentivise development of products addressing global disease burdens. These results may inform policies to better align pharmaceutical innovation with the burdens of disease.
  • Publisher: England: British Medical Journal Publishing Group
  • Language: English
  • Identifier: ISSN: 2044-6055
    EISSN: 2044-6055
    DOI: 10.1136/bmjopen-2023-076542
    PMID: 38471684
  • Source: ProQuest One Psychology
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