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Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study.

Kesselheim AS, Wang B, Franklin JM, Darrow JJ - BMJ (2015)

Bottom Line: 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).In the past two decades, drugs newly approved by the FDA have been associated with an increasing number of expedited development or review programs.

View Article: PubMed Central - PubMed

Affiliation: Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston 02120, MA, USA akesselheim@partners.org.

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Fig 2 Time trend analyses of all expedited programs associated with therapeutics approved by US Food and Drug Administration, 1987-2014. Top: mean number of expedited development and FDA review programs (orphan, accelerated approval, fast track, and priority review) granted to each newly approved prescription drug from 1987-2014. Drugs can be associated with more than one program. Bottom: proportion of newly approved prescription drugs from 1987-2014 that were associated with at least one of the four programs
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fig2: Fig 2 Time trend analyses of all expedited programs associated with therapeutics approved by US Food and Drug Administration, 1987-2014. Top: mean number of expedited development and FDA review programs (orphan, accelerated approval, fast track, and priority review) granted to each newly approved prescription drug from 1987-2014. Drugs can be associated with more than one program. Bottom: proportion of newly approved prescription drugs from 1987-2014 that were associated with at least one of the four programs

Mentions: Drugs could qualify for more than one program, and the average number of expedited development and review programs granted to each newly approved agent varied from a low of 0.53 in 1987 to a high of 1.72 in 2014 (see supplementary appendix for yearly data). During the entire study period, we observed a significant increase in trend of 2.6% per year (incidence rate ratio 1.026, 95% confidence interval 1.017 to 1.035), P<0.001) (fig 2). We also observed a 2.4% increase in the proportion of drugs associated with at least one program (odds ratio 1.024, 95% confidence interval 1.006 to 1.043, P=0.009), peaking at 75% (15/20) in 2005. The results were consistent when the orphan drug designation was excluded, with a 2.5% increase in the number of programs for each drug (incidence rate ratio 1.025, 95% confidence interval 1.014 to 1.036) and 2.3% increase in the proportion of drugs associated with at least one program (1.023, 1.005 to 1.042).


Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study.

Kesselheim AS, Wang B, Franklin JM, Darrow JJ - BMJ (2015)

Fig 2 Time trend analyses of all expedited programs associated with therapeutics approved by US Food and Drug Administration, 1987-2014. Top: mean number of expedited development and FDA review programs (orphan, accelerated approval, fast track, and priority review) granted to each newly approved prescription drug from 1987-2014. Drugs can be associated with more than one program. Bottom: proportion of newly approved prescription drugs from 1987-2014 that were associated with at least one of the four programs
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4580726&req=5

fig2: Fig 2 Time trend analyses of all expedited programs associated with therapeutics approved by US Food and Drug Administration, 1987-2014. Top: mean number of expedited development and FDA review programs (orphan, accelerated approval, fast track, and priority review) granted to each newly approved prescription drug from 1987-2014. Drugs can be associated with more than one program. Bottom: proportion of newly approved prescription drugs from 1987-2014 that were associated with at least one of the four programs
Mentions: Drugs could qualify for more than one program, and the average number of expedited development and review programs granted to each newly approved agent varied from a low of 0.53 in 1987 to a high of 1.72 in 2014 (see supplementary appendix for yearly data). During the entire study period, we observed a significant increase in trend of 2.6% per year (incidence rate ratio 1.026, 95% confidence interval 1.017 to 1.035), P<0.001) (fig 2). We also observed a 2.4% increase in the proportion of drugs associated with at least one program (odds ratio 1.024, 95% confidence interval 1.006 to 1.043, P=0.009), peaking at 75% (15/20) in 2005. The results were consistent when the orphan drug designation was excluded, with a 2.5% increase in the number of programs for each drug (incidence rate ratio 1.025, 95% confidence interval 1.014 to 1.036) and 2.3% increase in the proportion of drugs associated with at least one program (1.023, 1.005 to 1.042).

Bottom Line: 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).In the past two decades, drugs newly approved by the FDA have been associated with an increasing number of expedited development or review programs.

View Article: PubMed Central - PubMed

Affiliation: Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston 02120, MA, USA akesselheim@partners.org.

Show MeSH
Related in: MedlinePlus