The biotech industry and FDA agree that pending accelerated approval legislation would facilitate expansion of the pathway to conditions beyond HIV/AIDS and cancer, but they have different opinions about the pace and scope of change that should be expected.

BIO, which hammered out the accelerated approval proposals in discussions with FDA, expects a quick spike in the percentage of drugs marketed under accelerated approval and a boost in funding for emerging companies as investors are persuaded that expansion of accelerated approval will reduce regulatory risk.