Evaluation of the Generic Drug User Fee Act (GDUFA) Program for Fiscal Years 2013-2022.
Abbreviated new drug application (ANDA)
Generic drug approvals
Generic drug user fee act (GDUFA)
Journal
The AAPS journal
ISSN: 1550-7416
Titre abrégé: AAPS J
Pays: United States
ID NLM: 101223209
Informations de publication
Date de publication:
24 Jul 2024
24 Jul 2024
Historique:
received:
19
03
2024
accepted:
17
06
2024
medline:
24
7
2024
pubmed:
24
7
2024
entrez:
23
7
2024
Statut:
epublish
Résumé
The effectiveness of the regulatory initiatives, strategies, and incentives put forth in the first two authorizations of the Generic Drug User Fees Act (GDUFA) were evaluated using factors including the number of Abbreviated New Drug Application (ANDA) withdrawals and first-cycle approvals. GDUFA was originally authorized in 2012 for FY 2013-2017 (GDUFA I) and reauthorized for FY 2018-2022 (GDUFA II). ANDA approvals were analyzed from the Drugs @ FDA database covering 2013-2022. From the applications, the approval time, dosage form and route of administration (ROA), product indication, market status of the product, first generic status, company and company size filing the ANDA were noted. Despite the COVID pandemic, there was more than a 40% increase in ANDA approvals during GDUFA II relative to GDUFA I. Oral and parenteral drugs were the two leading categories of approved generics during both iterations of GDUFA. There was more than a 120% increase in withdrawn applications during GDUFA II, which reflects the partial refund that is now offered to incentivize companies to withdraw inadequate applications prior to review. This also appears to have contributed to an increase in the number of first-cycle approvals, which increased by 100% between GDUFA I and II. Due to the COVID-19 public health emergency, there was a decrease in activity within the generic drug program and market. Therefore, it is important to consider this impact when observing actual trends from this study.
Identifiants
pubmed: 39043991
doi: 10.1208/s12248-024-00948-0
pii: 10.1208/s12248-024-00948-0
doi:
Substances chimiques
Drugs, Generic
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
85Informations de copyright
© 2024. The Author(s), under exclusive licence to American Association of Pharmaceutical Scientists.
Références
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FDA, GDUFA reauthorization performance goals and program enhancements fiscal years. 2018–2022. 2017 01/15/2023]; https://www.fda.gov/media/101052/download .
FDA. Activities Report of the Generic Drug Program (FY. 2013). 2013 03/15/2022]; https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/activities-report-generic-drug-program-fy-2013 .
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FDA. GDUFA II Overview. 2016 08/15/2021]; https://sbiaevents.com/files/GDUFA-II-Webinar-Oct-2016.pdf .
FDA. GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years. 2018–2022. 2018 08/15/2021]; https://www.fda.gov/media/101052/download .