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Health Aff (Millwood). 2017 Aug 1;36(8):1408-1415. doi: 10.1377/hlthaff.2016.1541.

Drugs Cleared Through The FDA's Expedited Review Offer Greater Gains Than Drugs Approved By Conventional Process.

Author information

1
James D. Chambers (jchambers@tuftsmedicalcenter.org) is an investigator at the Center for the Evaluation of Value and Risk in Health, Tufts Medical Center, and an associate professor of medicine in the School of Medicine, Tufts University, in Boston, Massachusetts.
2
Teja Thorat was a senior research associate at the Center for the Evaluation of Value and Risk in Health, Tufts Medical Center, when she worked on this article. She is currently a manager at Vertex Pharmaceuticals, Inc.
3
Colby L. Wilkinson is a research assistant in the Center for the Evaluation of Value and Risk in Health, Tufts Medical Center.
4
Peter J. Neumann is director of the Center for the Evaluation of Value and Risk in Health, Tufts Medical Center, and a professor of medicine in the School of Medicine, Tufts University.

Abstract

We investigated whether drugs approved by the Food and Drug Administration (FDA) through expedited review have offered larger health gains, compared to drugs approved through conventional review processes. We identified published estimates of additional health gains (measured in quality-adjusted life-years, or QALYs) associated with drugs approved in the period 1999-2012 through expedited (seventy-six drugs) versus conventional (fifty-nine) review processes. We found that drugs in at least one expedited review program offered greater gains than drugs reviewed through conventional processes (0.182 versus 0.003 QALYs). We also found that, compared to drugs not included in the same program, greater gains were provided by drugs in the priority review (0.175 versus 0.007 QALYs), accelerated approval (0.370 versus 0.031 QALYs), and fast track (0.254 versus 0.014 QALYs) programs. Our analysis suggests that the FDA has prioritized drugs that offer the largest health gains.

KEYWORDS:

Pharmaceuticals; innovation

PMID:
28784733
DOI:
10.1377/hlthaff.2016.1541
[Indexed for MEDLINE]

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