Reauthorization of the Prescription Drug User Fee Act


The National Health Council (NHC) appreciates the opportunity to provide a response to the Food and Drug Administration’s (FDA’s) request for comments on the next cycle of the Prescription Drug User Fee Act (PDUFA). In recent reauthorizations of PDUFA, the NHC has supported a number of provisions to bring the patient perspective into drug development and modernize the development and regulation of treatments for people with chronic diseases and disabilities. We look forward to working with the FDA to make further advances in PDUFA VII.

Created by and for patient organizations 100 years ago, the NHC brings diverse organizations together to forge consensus and drive patient-centered health policy. We promote increased access to affordable, high-value, sustainable health care. Made up of more than 140 national health- related organizations and businesses, the NHC’s core membership includes the nation’s leading patient organizations. Other members include health-related associations and nonprofit organizations including the provider, research, and family caregiver communities; and businesses representing biopharmaceutical, device, diagnostic, generic, and payer organizations.

As we shared at the July 23, 2020 stakeholder meeting convened by the FDA, the NHC recommends the next PDUFA should address:

  • Expansion and Enhancement of Core Outcome Set Program to Increase Patient-Centricity and Impact;
  • Continued Examination of the Potential Regulatory Uses for Real-World Evidence (RWE);
  • Decreasing Burden through Digital Clinical Trials;
  • Embedding Patient-Experience Data Throughout the Knowledge Management System; and
  • Evolving the Science of Patient Engagement through Increased FDA Staff Capacity.

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