In addition to reauthorizing the Prescription Drug User Fee Act, which will generate more than $4 billion in user fees for FY13-FY17, the Food and Drug Administration Safety and Innovation Act (S.3187) contains several measures intended to reform FDA. Source: S.3187; FDA performance goals and procedures



Accelerated approval

Encourages FDA to use Fast Track designation and accelerated approval for "a broad range of serious or life threatening diseases or conditions"

Advisory committee conflicts

Eliminates caps on conflict-of-interest waivers for advisory committee members

Antibiotic incentives

New anti-infective drugs against pathogens with "potential to pose a serious threat to public health" receive Priority Review and five years of exclusivity in addition to any Orphan, NCE or pediatric exclusivity