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This article was originally published in The Tan Sheet

Executive Summary

FDA SENIOR LEVEL REDUCTIONS COULD AFFECT HIRING OF 80 CDER STAFF POSITIONS called for by the user fee agreement. Senior staffing reductions have recently been mandated throughout the Public Health Service under a presidential executive order. Those cuts have already created hurdles for user fee hiring at a time when the Center for Drug Evaluation & Research is supposed to be rapidly recruiting new reviewers. Under FDA's proposed Senior Level Staffing Reduction Plan for Civilian Staff, each new hire at the GS-14 or GS-15 level will have to be reviewed by the Office of the Commissioner, adding an extra layer of pre-hiring approval. The restrictions on senior staff positions could have a disproportionately greater impact on the hiring of medical reviewers and expert scientists. According to an Oct. 22 memo from Commissioner David Kessler to FDA center directors, written justification will have be included in all requests for senior positions indicating "compelling programmatic reasons why it is necessary to fill [the] position at this time." The centers will also be required to describe the status of candidates and recruitment efforts for "hard to fill" positions. The staffing plan not only affects new user fee hires but many vacancies and promotions that had been promised to certain senior level employees. Office of OTC Drug Evaluation Director Michael Weintraub, MD, who received SES status during the week of Nov. 29, may be one of the last to receive such a promotion for a while. Meanwhile, in other areas of CDER, the top spots in the Office of Generic Drugs and the Anti-infective Drugs Division remain without permanent directors. The FDA senior staffing reduction plan responds to a PHS plan submitted to the agency in early October. The PHS plan was designed to cut back OS-14, GS-15 and SES positions to the agency's FY 1992 level of 1,288. FDA responded by suggesting that the senior level positions should be frozen at the current number of 1,389. The agency is awaiting an official response from PHS on the proposed plan. The hiring constraints have evolved from two contradictory government initiatives: the user fee legislation, which requires the hiring of over 600 new staff in CDER and the Center for Biologics Evaluation & Research; and a February 1993 presidential executive order requiring a 10% reduction in supervisory management positions over the next three years. In a memo to PHS, FDA Deputy Commissioner for Management & Systems Mary Jo Veverka noted that "due to the need for physicians and expert scientists in [application review] programs, approximately one-third of the review professionals [to be hired] are planned at the senior levels." Veverka estimated that without the staffing controls being mandated by PHS, 200 new senior level positions would be created leading to an "on-board total of 1,589" by the end of the current fiscal year on Sept. 30, 1994. Veverka called the PHS proposal to keep FY 1994 senior staff levels to 1,288 "unrealistic and unattainable" in light of the fact that FDA already has 1,389 on board and that Office of Management and Budget "Director Leon Panetta has assured our House Appropriations subcommittee Chairman [Rep. Richard] Durbin [D- Ill.] in writing that FDA will grow by 600 positions to an on- board total of 9,700 in FY 1994." In addition, Veverka noted that "the original premise of the senior level reductions is that they are a percentage of overall cuts in agency staffing when in fact FDA is not reducing staffing but rather growing." The deputy commissioner asserted that the original target of 1,288 "would virtually guarantee failure of FDA's Prescription Drug User Fee Program and also severely hamper mammography and other critical medical device initiatives." Setting the level of senior staff hires at 1,389 would "give [FDA] a fighting chance," Veverka said, calling that target "very difficult, but achievable with pain and discipline." The plan proposed by FDA would seek to reduce senior staffing, Veverka said, through normal attrition of approximately 40 people per year, and buyouts of 10 of the 434 employees who are eligible for regular retirement or discontinued service retirement, for a total of 50. The plan allows for the hiring of only 50 new senior staff or replacements in FY 1994 instead of the original 200 that would have been hired without staffing controls. FDA's plan proposes to control new senior staff hiring by limiting or reducing "planned senior level positions resulting from program growth such as user fees and new medical device activities." Veverka said that the agency will try to fill user fee and device positions at the GS-13 level "whenever possible." Medical reviewers and expert scientists are generally hired at the GS-14 level with promised promotions to GS-15 to be able to compete with offers outside the agency.

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