Every five years since 1992, Congress has reauthorized the Food and Drug Administration user fee package to allow the agency to collect funds from companies that produce human drugs and biological products. Over the last 30 years, this process has helped the FDA, the biomedical industry, and Congress to rethink, redesign, and modernize existing FDA programs and pathways as well as introduce new regulatory policies to advance drug development and approvals.
But it still isn’t fast or innovative enough to help Americans living with rare or life-threatening and progressive diseases.