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Measures of Program EffectivenessApproval RatesAre products that receive Fast Track designation more likely to have their NDA/BLA approved by FDA than products that receive no such designation? The answer is we don't know, because, while FDA provides statistics on the products it designates as Fast Track, it does not make public information on the NDA/BLAs it receives unless and until the product is approved/licensed.

What we do know from material on the FDA website: • Manufacturers have requested Fast Track designation for 569 drugs and 195 biological products since the Fast Track program was set into law. • FDA granted the designation to 74.5% of those drug requests and 63.6% of those biologics requests.


• Of products with Fast Track designation, FDA eventually approved 10.6% of the drugs and licensed 17.7% of the biologics.6


What that means is obscured by what we do not know: • For what percentage of products with Fast Track designation do sponsors submit NDA/BLAs? How many NDA/BLAs submitted each year are for Fast Track products? With only the numerator (approved products), one cannot calculate the percentage of NDA/BLA submissions that are approved among Fast Track products.FDA receives approximately 100-130 applications a year, and has stated that "close to 80 percent of all filed applications will eventually be approved."7

The 10.6 and 17.7% figures for Fast Track are not a comparable statistic because they include the apparently large, but unquantified, number of product development attempts that manufacturers discontinue (for safety problems, lack of effectiveness, business decisions, competing projects). A useful analysis would account for the percentage of Fast Track and non-Fast Track products of which FDA is aware (e.g., that have INDs) that result in submitted NDA/BLAs.