SWHR Supports Continuation of FDA User Fee Programs

Policy Engagement

Published 5/22/17

SWHR issued a letter supporting the continuation of the Food and Drug Administration (FDA) user fee programs in order to guarantee sufficient scientific capacity and expertise at the FDA, thereby allowing the agency to carry out its public mission.

SWHR supports the user fee reauthorization agreements in the Prescription Drug User Fee Act (PDUFA) VI, Medical Device User Fee Act (MDUFA) IV, Biosimilar User Fee Act (BsUFA) II, and Generic Drug User Fee Act (GDUFA) II, which are the culmination of months of negotiations between FDA, industry, and the patient advocate community. They include many important improvements for ensuring greater consistency, certainty, and predictability of the FDA regulatory review and approval process.

SWHR recommends the legislation’s continuation of the Patient-Focused Drug Development (PFDD) Program, which integrates a patient’s perspective into the development process, and the use of data collection tools such as patient-reported outcomes. SWHR also endorses the inclusion of provisions consistent with the 21st Century Cures Act that advance the development and application of regulatory science to explore the use of real-world evidence and innovative clinical trial approaches.

Read The Letter