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U.S. Department of Health and Human Services

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Task Background and Objectives

Planned Review Timelines Assessment: Table of Contents

On September 27, 2007, the Food and Drug Administration Amendments Act of 2007 (FDAAA) was signed into law, which reauthorized the Prescription Drug User Fee Act of 1992 (PDUFA) in Title I, Prescription Drug User Fee Amendments of 2007 (PDUFA IV). In conjunction with the reauthorization of PDUFA, the Food and Drug Administration (FDA) agreed to meet specific performance goals, described in PDUFA Reauthorization Performance Goals and Procedures. Under Goal X of the PDUFA IV goals, First Cycle Review Performance Proposal, FDA agreed to further enhancements, including notifying applicants in the Filing Communication letter of a target date for communication of feedback from the review division regarding proposed labeling and postmarketing commitments (PMCs)[5] the Agency will be requesting.[6] In FY09, the first year of the new requirement, only NME NDAs and original BLAs were required to include the target date in the Filing Communication letter.

 
The Center for Drug Evaluation and Research (CDER) Manual of Policies and Practices (MaPP) 6010.8 was finalized in June 2008 and established the procedures for communicating the planned review timelines for CDER staff. According to the MaPP, the planned review timelines for communication of labeling comments and PMR/PMC requests:
 
• Will be consistent with the GRMPs for NDAs and BLAs, taking into consideration the specific circumstances surrounding the individual application.
• Will be based on the original PDUFA goal date.
• Will set forth the target date for communication of proposed labeling comments and PMR/PMC requirements and requests.
 
Major amendments to the application may change the timeline or in certain circumstances, cause the timeline to be withdrawn and not reissued.
 
CBER’s policy for communicating the planned review timelines is contained in Standard Operating Procedures and Policies 8401.3. In CDER, RPMs and review disciplines were provided training opportunities through the Office of Training and Communications, as well as videotaped versions of the class that could be viewed as needed. Both Centers facilitated implementation of the new requirement by creating filing communication letter templates that contained new language to communicate the planned review timelines to applicants.
 
As of September 30, 2009,[7] performance data were available for 44 of 55 (80%) of the planned review timelines notifications for original NMEs and BLAs, and FDA met the commitment for 86% (38/44) of them. FDA committed under PDUFA IV to report its performance in meeting the planned review timelines for communication of labeling comments and PMR/PMC requirements and requests. This includes reporting on the number and percentage of applications for which the planned target dates for communication on labeling comments and PMR/PMC requirements and requests were met. As of September 30, 2009, data showed FDA had met the planned target date for 39% (7/18) of the applications.
 
The key objective of this task is to assess the progress of CDER and CBER in adhering to the planned review timelines. To accomplish this assessment, this task focuses on the following activities:
 
• Conduct a root-cause analysis to identify the main obstacles and enablers impacting adherence to planned review timelines
• Recommend actions that would improve the effectiveness of the adherence to planned review timelines
 

Next Section: Methodology


[5] Although PDUFA Goal X only mentions PMCs, PDUFA IV created an FDA authority to require postmarketing requirements (PMRs), which FDA includes in the planned review timelines notification.
[6] In the event that deficiencies preclude the discussion of labeling or PMRs/PMCs, FDA can meet the requirement by communicating this to the applicant by the target date.
[7] The data in this report are those published in the FY 2009 Performance Report to the President and Congress on the Prescription Drug User Fee Act. While this study report was in final preparation, the FY 2010 Performance Report was released, which included updated FY 2009 numbers, shown in Appendix B.