Congress Set To Expand FDA Priority Review Vouchers; Some Raise Concerns Over Program
CQ HealthBeat: Popular Priority Drug Reviews Face Scrutiny
“…Since the priority review voucher program was established in 2007, only nine have been awarded, mostly for drugs treating rare pediatric diseases and some for tropical diseases like malaria and tuberculosis. But five of those were awarded in 2015 alone. With Congress poised to expand the program, the pace could increase. That raised concerns within the Food and Drug Administration about whether it has the resources to handle the faster approval timelines. Others note that companies can win vouchers for drugs that were already approved years earlier in other countries, which limits the incentives to pursue innovative treatments…” (Siddons, 3/25).