A517number of expedited approval programs. The objective of this study was to evaluate these programs by examining whether drugs included in them have provided larger health gains than drugs excluded from them. Methods: We considered the FDA's priority review, accelerated approval, and fast-track programs. We estimated health gains in terms of quality-adjusted life-years (QALYs) for drugs approved for the first time between 1999 and 2011, relative to treatments available at the time of their approval. We identified QALY estimates from published cost-utility analyses, and comparative effectiveness studies that estimated relative effectiveness using QALYs. We excluded studies that compared drugs to placebo or no treatment when an alternative active treatment was available, and to be conservative we excluded estimates from studies supported by the pharmaceutical industry. We compared QALY gains for drugs included in the designation programs vs. drugs excluded from them using Mann Whitney U tests. Results: We identified QALY gain estimates for 102 drugs, representing approximately 40% of drugs approved between 1999 and 2011. We included 15 of 37 drugs approved through accelerated approval, 54 of 149 drugs approved through priority review, and 24 of 65 drugs approved through fast-track designation. Drugs in the priority review program had mean QALY gains of 0.35 vs. -0.02 for drugs excluded (p= 0.011). Drugs included in the accelerated approval program had mean QALY gains of 0.43 vs. 0.13 for drugs excluded (p= 0.039). Drugs included in the fast-track designation program had mean QALY gains of 0.34 vs. 0.12 for drugs excluded (p= 0.014). ConClusions: This study suggests that drugs included by FDA in accelerated review programs have larger clinical gains than drugs excluded from the programs.

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