PDUFA IV Five-Year Financial Plan - 2009 Update: CBER Plan Summary
CBER Plan Summary
CBER plans for FY 2008 and the subsequent fiscal years authorized in PDUFA IV are summarized below, using the PDUFA IV funding base and increase categories.
Increases to the PDUFA IV Funding Base
In FY 2008, CBER plans to increase review staffing by about 53 FTE, just to sustain the work necessary to continue to meet PDUFA III performance goals that are incorporated into PDUFA IV. Under PDUFA III, funding levels did not keep up with increases in workload and therefore CBER employed fewer review staff than needed to meet goals. This led to CBER's inability to meet some goals and to insufficient staffing levels to be able to provide necessary staff development opportunities.
The additional PDUFA IV base funds will be used to hire and train needed drug review staff and continue professional development to existing staff. CBER will continue to focus resources on enhancement of the application evaluation process and related performance commitments as well as in PDUFA IV significant expansion of the post-market safety activities.
Drug Safety /Risk Management
The center will hire an additional 4 FTE and utilize $1 million in contract support in 2008 to work on negotiated drug safety objectives, and these staff and contract funds will be supported through FY 2012. The resources will focus on assessing current and new methodologies to collect adverse event information during the product lifecycle and expand database acquisition for targeted post-marketing surveillance
Additional Drug Safety Increase
The center will hire an additional 10 FTE and utilize $378,000 in contract funds in 2008 to work on additional drug safety objectives. Additional staff for this purpose will increase steadily each year, as shown in the table below.
Additional CBER FTE for Additional Drug Safety Increases by Year
In addition, CBER, will utilize $378,000 in contract funds for this effort in FY 2008, and contract funds will grow steadily to a total of almost $1.3 million in FY 2012.
The work that will be accomplished under this initiative includes taking steps to support and strengthen its post-market safety activities. CBER is increasing the staff in the Office of Biostatistics and Epidemiology for safety activities. In addition, CBER will continue to include members of the Division of Epidemiology on all new vaccine BLA committees to review pharmacovigilance plans for post-marketing safety studies submitted by manufacturers. CBER has also put in place interdisciplinary product safety teams and will be expanding resources and FTE's to access and analyze health care databases.
Workload Adjustment Increases
The September 2008 PDUFA 5-Year Financial Plan reflected a workload adjustment that was made in 2009 (3 percent) and then increased only for inflation each subsequent year. That adjustment funded a total of 10 FTE for CBER in FY 2009, and maintained that same FTE level for the remaining 3 years. This FY 2009 Update to the plan reflects the increase of 6.82 percent in FY 2010, and annual increases at the rate of 3.41 percent for each subsequent year. With these revised assumptions, the workload adjustment funds an additional 11 FTE in FY 2010, for a total of 21 FTE that year. It funds an additional 11 FTE in FY 2011, for a total of 32 FTE in FY 2011. It funds an additional 12 FTE in FY 2012 for a total of 44 FTE in FY 2012 funded from the workload adjustment increases. These additional FTE will help assure that CBER is better able to meet its performance goals.