FDA and Stakeholders Kick Off PDUFA Renewal Negotiations
At a public meeting in July 2020 to launch negotiations for renewing the Prescription Drug User Fee Act (PDUFA) before the current program expires in September 2022, patient advocates, research experts, and industry presented their preferences for tapping user fee revenues to support a range of FDA initiatives, including broader use of real-world evidence and innovative clinical trial methods to advance new therapies and for FDA to expand electronic communications systems in research and regulatory programs. A prominent theme is for the agency to incorporate innovations and program changes adopted for dealing with the COVID-19 pandemic into ongoing research policies and regulatory activities (1).
Several stakeholders also urged increased funding for the Center for Biologics Evaluation and Research (CBER) to support development of advanced therapies for rare diseases. Cartier Esham, executive vice-president of the Biotechnology Innovation Organization, cited the greater demand on CBER personnel for multiple meetings with sponsors and the need to clarify expedited pathways and expand standards for advanced manufacturing processes and technologies for gene therapies.
Over the coming months, FDA will seek input from industry leaders and representatives of consumer and patient organizations, research entities, and healthcare organizations to present Congress with a user fee agreement by the middle of next year so that the legislators can write and approve authorizing legislation by early 2022.
1. FDA, “Reauthorization of the Prescription Drug User Fee Act; Public Meeting; Request for Comments,” Notice, Federal Register, 85 FR 35096, 35096-35099.