ArticleBMJ (Clinical research ed.)2015
Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study.
Article in BMJ (Clinical research ed.), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 77 papers, 2 of them syntheses that pooled it.
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Who cites it
77 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- New Drug Postmarketing Requirements and Commitments in the US: A Systematic Review of the Evidence.Drug safety · 2022Pooled it
- Response Rate as a Regulatory End Point in Single-Arm Studies of Advanced Solid Tumors.JAMA oncology · 2016Pooled it
- Are Disease Awareness Links on Prescription Drug Websites Misleading? A Randomized Study.Journal of health communication · 2016Trial
- Re-engineering insulin for oral delivery: structural modifications, advanced formulation strategies, and future directions.Drug delivery · 2026Review
- Technology profiles in FDA-approved new molecular entities, 2013-2024: a latent class analysis.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2026Article
- Orphan Designation for Drugs Approved in the United States and European Union: A Comparative Analysis.Clinical pharmacology and therapeutics · 2026Article
- Proposing a Coverage With Evidence Development Framework for Accelerated Approval at the U.S. Food and Drug Administration.Pharmacoepidemiology and drug safety · 2026Article
- Premarket and postmarket real-world evidence studies supporting U.S. Food and Drug Administration regulatory decision-making, 2016-2024.Clinical trials (London, England) · 2026Article
- Deficiencies Delaying Prescription Drug Approvals by the U.S. Food and Drug Administration, 2020-2024.Therapeutic innovation & regulatory science · 2026Article
- Expedited pathway portfolios, trial complexity, and FDA approval timelines in oncology and neurology: A comparative analysis.PloS one · 2026Article
- Review
- Current landscape of US Food and Drug Administration use of expedited regulatory approvals for colorectal cancer care.Journal of managed care & specialty pharmacy · 2025Article
- Orphan Drug Approval in Canada, 1999-2022: A Cross-sectional Study.International journal of health policy and management · 2025Article
- Are Drug Novelty Characteristics Associated With Greater Health Benefits?Applied health economics and health policy · 2024Article
- New Oncologic Drugs from 2008 to 2023-Differences in Approval and Access between the United States, Europe and Brazil.Current oncology (Toronto, Ont.) · 2024Article
- Comparing prospectively assigned trial and real-world lung cancer patients.Journal of comparative effectiveness research · 2024Article
- FDA Breakthrough Therapy Designation Reduced Late-Stage Drug Development Time.Health affairs (Project Hope) · 2024Article
- Article
- Analysis of US Food and Drug Administration new drug and biologic approvals, regulatory pathways, and review times, 1980-2022.Scientific reports · 2024Article
- Rapid access to innovative medicinal products while ensuring relevant health technology assessment. Position of the French National Authority for Health.BMJ evidence-based medicine · 2024Article
17 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo evaluate the use of special expedited development and review pathways at the US Food and Drug Administration over the past two decades.
designCohort study.
settingFDA approved novel therapeutics between 1987 and 2014. POPULATION: Publicly available sources provided each drug's year of approval, their innovativeness (first in class versus not first in class), World Health Organization Anatomic Therapeutic Classification, and which (if any) of the FDA's four primary expedited development and review programs or designations were associated with each drug: orphan drug, fast track, accelerated approval, and priority review.
main outcome measuresLogistic regression models evaluated trends in the proportion of drugs associated with each of the four expedited development and review programs. To evaluate the number of programs associated with each approved drug over time, Poisson models were employed, with the number of programs as the dependent variable and a linear term for year of approval. The difference in trends was compared between drugs that were first in class and those that were not.
resultsThe FDA approved 774 drugs during the study period, with one third representing first in class agents. Priority review (43%) was the most prevalent of the four programs, with accelerated approval (9%) the least common. There was a significant increase of 2.6% per year in the number of expedited review and approval programs granted to each newly approved agent (incidence rate ratio 1.026, 95% confidence interval 1.017 to 1.035, P<0.001), and a 2.4% increase in the proportion of drugs associated with at least one such program (odds ratio 1.024, 95% confidence interval 1.006 to 1.043, P=0.009). Driving this trend was an increase in the proportion of approved, non-first in class drugs associated with at least one program for drugs (P=0.03 for interaction).
conclusionsIn the past two decades, drugs newly approved by the FDA have been associated with an increasing number of expedited development or review programs. Though expedited programs should be strictly limited to drugs providing noticeable clinical advances, this trend is being driven by drugs that are not first in class and thus potentially less innovative.
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