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This section reports on management initiatives detailed in sections VII through XI of the PDUFA III commitment letter. A full description of the goals, the annual performance targets, and definitions of terms can be found in Appendix A. This section reports on accomplishments in FY 2004.
Continuous Marketing Application Pilots: The first Continuous Marketing Application (CMA) pilot (Pilot 1) applies to fast track products that have demonstrated significant promise as a therapeutic advance in clinical trials, and will provide an early discipline review of the RUs of the sponsor's NDA/BLA submitted in advance of the complete application. The second CMA pilot (Pilot 2) applies to fast track products and provides for FDA-sponsor agreement to engage in frequent scientific feedback and interactions during the clinical trial phase of product development.
FY 2004 Accomplishments: Final guidances were published on October 6, 2003, and the pilot programs became effective as of that date. As of September 30, 2004, eight products had been identified for inclusion in Pilot 1. The RUs for seven of these products have been received. As of September 30, 2004, 38 percent (5 of 13) of RUs received had been reviewed and acted on and all within the goal time. Additionally, seven products were included in the Pilot 2 program as of September 30, 2004.
First Cycle Review Performance: Approvals that take more than one review cycle to complete are generally not in the best interest of the public, the agency, or the company submitting the product application. Although sometimes additional review cycles are necessary to resolve important issues regarding safety, quality, or efficacy, in most cases, the extra cycles could be avoided, saving time and effort. For applications that are ultimately approved, the causes of multiple review cycles can include deficiencies in sponsors' applications, communication problems during the review process, or difficulty finishing final negotiations on such topics as labeling. Sometimes additional review cycles are necessary to resolve important issues regarding safety, quality, or efficacy; but in other cases, the extra cycles could be avoided, saving time and effort. Efforts to improve the first cycle review process include an initiative for notification of substantive deficiencies identified during the initial filing review for original NDAs and BLAs and an initiative to develop and publish Good Review Management Principles (GRMP) with provisions for both FDA reviewers and industry sponsors.
FY 2004 Accomplishments: As of September 30, 2004, 85 percent (109 of 128) of NDAs, 78 percent (7 of 9) of BLAs, and 81 percent (105 of 130) of efficacy supplements have received an initial filing review. Although it is too early to make a final determination, performance is well over the targeted performance levels for FY 2004. Additionally, FDA is implementing the PDUFA III First Cycle initiative to develop and publish the GRMP. The draft GRMP guidance was published on July 28, 2003, and the comment period ended on September 11, 2003. FDA received extensive comments on the draft guidance and has been evaluating the comments and revising the guidance through FY 2004.
Improving FDA Performance Management: Under the PDUFA III performance management goal, FDA will conduct initiatives that are targeted to improve the new drug review process. FDA will award a task order contract to a contractor with the expertise to conduct evaluations and analyses of the new drug review process. The first tasks will include a retrospective evaluation of the first cycle review process, an evaluation of the first cycle initiatives under PDUFA III, and an evaluation of the continuous marketing application pilots. FDA will also contract for outside expert consultants for analysis, training, and technical assistance to help implement a quality systems approach to the new drug review process.
FY 2004 Accomplishments: FDA awarded a task order contract to conduct evaluations of the first cycle and CMA pilot initiatives. CDER worked with a contractor on process improvements and on aspects of a quality system for new drug review.
Independent Consultants: This PDUFA III initiative allows a sponsor to request that FDA engage an independent expert consultant during the development period for certain biotechnology products. The consultant would be selected by FDA to assist in the Agency's review of the protocol for the clinical studies that would support the claims for the product. This initiative is intended to facilitate product development.
FY 2004 Accomplishments: Final guidance was published on August 18, 2004. So far no sponsors have requested assistance under the program. The final guidance is available at: http://www.fda.gov/cber/gdlns/bioclin.htm.
Risk Management: The postmarketing initiative to address postmarket risk both before an application is submitted and during the review process will facilitate postmarket risk management by helping FDA better understand any risks and by providing feedback to the sponsors. Guidances will be published for three areas: Good Risk Assessment, Risk Management, and Pharmacovigilance Practices.
FY 2004 Accomplishments: FDA published draft guidances on May 5, 2004, received extensive comments, and expects to publish all three final guidances in early FY 2005. Additionally, FDA participated in the review of 23 Risk Management Plans (RMPs) (including 5 NMEs and one BLA) of which 11 were related to NDAs submitted after PDUFA III took effect. FDA also participated in 20 pre-NDA/BLA supplement review meetings, 3 pre-approval safety conferences, 3 peri-approval RMP reviews, and the evaluation/validation of 4 active RMPs.