FDA Reviewer Retention Remains Priority In FY 2001 - User Fee Report
This article was originally published in The Tan Sheet
Executive Summary
FDA will implement ideas from employee focus groups in FY 2001 to try to improve the retention rate in its drug review divisions, the agency said in its fiscal 2000 Prescription Drug User Fee Act Financial Report.
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FDA will implement ideas from employee focus groups in FY 2001 to try to improve the retention rate in its drug review divisions, the agency said in its fiscal 2000 Prescription Drug User Fee Act Financial Report. "Retaining review staff and recruiting and training new review staff is a constant challenge," the report notes. The agency "conducted focus groups with review scientists to elicit their views on factors impacting on their decisions to continue to work for FDA." During the year, FDA adopted "retention bonuses for reviewer mathematicians and statisticians" and worked "to facilitate review work from alternative work sites," the report states. Despite such efforts, FDA's review staff continued to experience turnover at a rate of about 10% in FY 2000, the report notes, adding "FDA's experienced reviewers are in demand and have excellent employment opportunities available to them." Sixty-five percent ($95.1 mil.) of user fees were spent on employee salary and benefits in FY 2000 compared to 62% ($75.6 mil.) the previous year. User fees financed 1,009 additional full-time equivalents to review human drug applications. The user fee program has nearly doubled the staff from the 1,277 FTEs involved in reviews prior to the 1992 user fee act. One temporary complication for FDA from a staffing perspective is the hiring freeze imposed during the presidential transition process. The freeze is directly affecting the Center for Drug Evaluation & Research's review management team; the center is understood to have selected a new deputy director but cannot complete the hire until the freeze is lifted (1 (Also see "CDER deputy director" - Pink Sheet, 5 Feb, 2001.)). Other challenges identified by FDA in the report reflect the agency's agenda for the user fee reauthorization process. The PDUFA program sunsets in 2002. The agency's need to maintain its science base to ensure that reviews are of high quality, and to stem the "erosion" in non-user fee funded activities such as post-marketing surveillance also are highlighted. The report was forwarded to Congress on Jan. 19, the last day of the Clinton Administration, by former HHS Secretary Donna Shalala. The change in Administrations raises the possibility that FDA's position on user fee reauthorization objectives will evolve. The Bush Administration does not appear to have a settled position on PDUFA; incoming HHS Secretary Tommy Thompson said during confirmation hearings that he is not familiar with the legislation. Within FDA, there will be continuity in pushing for funding for the science base and adding resources to non-user fee functions under Acting Commissioner Bernard Schwetz, PhD (2 (Also see "Hiring Freeze Will Affect FDA Commissioner, ORM Director Appointments" - Pink Sheet, 29 Jan, 2001.)). A decision by the Bush Administration to appoint a commissioner from within the ranks of current or recently departed FDA management also would signal continuity in the agency's user fee objectives. Costs for review of drug applications at CDER rose to $187.4 mil. in FY 2000 from $166.6 mil. in FY 1999. The FDA center's costs were up due to mandatory pay raises, increased staffing levels and increased information technology expenditures, the report states. FDA spent $147.3 mil. in user fees in fiscal 2000, a 20% increase over the previous year. As expected, user fee spending for the year exceeded collections of $137.7 mil.; the agency made up the difference by using funds carried over from earlier years of the program. The carryover balance heading into FY 2001 was $57.4 mil. FDA expects to spend about $9 mil. of the fund this year. The report indicates the agency will have to carefully monitor the carryover balance during the final year of the program. FDA estimates it needs to have $38.1 mil. remaining at the end of FY 2001 to cover essential future operating costs. The agency expects to allocate $9.6 mil. from the fund in FY 2002, and presumes another $6 mil. may be needed for pending fee waiver requests and refunds for overpayments. FDA's estimate of the total claims against the reserve fund is $62.7 mil. Although the amount exceeds the balance of the fund, the agency also has about $9.5 mil. in pending receivables. |