FDA Releases Two User Fee Related Implementation Plans - Drug Information Update

Today, the Food and Drug Administration is releasing two user fee related implementation plans – “Resource Capacity Planning & Modernized Time Reporting Implementation Plan” and the “Benefit-Risk Assessment in Drug Regulatory Decision-Making Implementation Plan.”  These plans fulfill goals set forth during  the latest reauthorization of PDUFA.  The “Resource Capacity Planning & Modernized Time Reporting Implementation Plan” outlines an approach to develop capabilities that will help ensure that the FDA is making optimal use of its user fee financial resources to maximize its ability to efficiently and effectively deliver on its commitments to the public. Through the development of these capabilities, FDA will be able to build more systematic, data-driven, and repeatable processes to better understand and anticipate its current and future resource demands, enabling FDA to more proactively ensure its organizational components are optimally resourced. FDA plans to host annual public meetings, beginning in 2019, to engage the public in discussions regarding its progress in the development of its resource capacity planning and modernized time reporting capabilities.  The FDA will welcome public comment regarding its approach and progress at these meetings.  Also, issued today is the “Benefit Risk Assessment in Drug Regulatory Decisions Making, Draft PDUFA VI Implementation Plan,” which is an update to the 2013 implementation plan titled “Structured Approach to Benefit-Risk Assessment in Drug Regulatory Decision-Making.” This plan offers an update on CDER’s and CBER’s actions in implementing FDA’s Benefit-Risk Framework (BRF) into our regulatory review processes and documentation. It summarizes the third-party evaluation of FDA’s implementation of the BRF. It outlines FDA’s commitments under PDUFA VI, including publication of a draft guidance on benefit-risk assessment for new drugs and biologics. Among other topics, this draft guidance will include discussion on how relevant patient experience data and related information may be used to inform benefit-risk assessment. FDA welcomes comments on this plan. FDA hopes that availability of both plans will support enhanced transparency of, and efficiencies in, FDA processes for drug developers. By enhancing transparency and efficiencies, the agency aims to help bring FDA-approved drug products to patients as quickly as possible