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FDA "SCIENTIFIC PLAN" FOR RECRUITING/RETAINING SCIENTISTS

Executive Summary

FDA "SCIENTIFIC PLAN" FOR RECRUITING/RETAINING SCIENTISTS is under development by two intra-agency groups, according to Susan Crandall, MD, a medical officer in FDA's Office of Science. Speaking at an Aug. 7 meeting of the Food and Drug Law Institute, Crandall explained that two groups of FDA scientists are working under the auspices of the Office of Science to "develop a fairly short-range science plan" focusing on "staff recruitment and retention" issues as well as "scientific infrastructure." A completed plan will be submitted to FDA Commissioner David Kessler by "the end of the year," Crandall said. In "looking at ways to attract good scientists to the agency," Crandall said that the FDA groups will evaluate "good ways to advertise what FDA science positions are about," and will consider the development of pre- and post-doctoral fellowship programs. To retain FDA scientists once they are hired, Crandall explained that the groups will delve into "quality of life issues" such as "short- and long-term training programs, sabbaticals, awards, and honors." The assessment of scientific infrastructure, an area Crandall acknowledged is "less well-defined," will include an examination of ways to procure laboratory and other scientific equipment, and "methods for opening lines of communication" between FDA scientists. The intra-agency groups include one called the "Senior Science Council," which is comprised of one senior scientist from each FDA center and the Office of Regulatory Affairs. The second group, dubbed "consultants to the Senior Advisor for Science," is composed of two "bench" scientists from each center and from ORA who are relatively new to FDA. Headed by Elkan Blout, MD, FDA's Office of Science was formed by Kessler in late 1991. Crandall also informed the FDLI audience that the agency is establishing a "science board to the FDA" in an effort to "improve our communication with the outside scientific community." The board will function as an advisory group and is expected to be composed of "various senior members of academia and from industry." The group will advise Kessler on "such issues as upgrading FDA scientific and research facilities" and the "formulation of appropriate research agendas for the agency." FDA is "in the process of chartering" the committee, and hopes to hold the first meeting of the advisory group in "late fall," Crandall said. Updating the FDLI members on the activities of FDA's Office of Management and Systems, Associate Commissioner for Management Sharon Holston reported that OMS is establishing a new Office for Strategic Systems. OMS currently is comprised of the Office of Management and the Office of Planning and Evaluation. The strategic systems office, which will be formed over the next six months, is expected to oversee the switch to automated application processes for FDA- regulated industries. Holston noted that "an enormous amount of groundwork has been laid," as OMS staffers are already working with the drugs and biologics centers on computerizing the new drug application and product license application processes. More generally, the new office will try "to move the agency toward a greater use of common information systems," Holston told FDLI, and will work to integrate existing information systems employed by individual centers. FDA already has begun recruitment for an associate commissioner for strategic systems, Holston said, adding that it is "not anticipated that [the office] will be a large organization. It probably will never have more than 10 or so people." Development of the strategic systems office is being headed by Special Assistant to the Commissioner for Management and Systems Mary Jo Veverka. Holston also noted that FDA is making progress on developing a "strategic plan" for carrying out its mission in years to come. In its fiscal 1993 budget proposal, HHS directed FDA to develop a "strategic plan that will establish goals for the agency into the 21st century" ("The Pink Sheet" Feb. 3, p. 13). The plan is expected to be completed in 1993. "The strategic plan is a living, breathing, evolving document" that is being developed under OMS and Veverka, Holston commented. "Just a couple of weeks ago, Dr. Kessler's senior staff took a one-day retreat" to "think about what the agency would be like in the year 2012," she noted. At the session, FDAers realized that "hand-in-hand with the strategic plan is the concept of user fees as a way to support the responsibilities of FDA," Holston continued, because the agency will never receive "the kind of resources that are necessary for FDA to do everything it has to do." FDA is currently struggling to pass user fees for prescription drugs alone (see related story p. 5). The associate commissioner stated that "more efficient organizational structures" also will be evaluated by OMS. Among other FDA initiatives mentioned by Holston is the formation of three task forces to explore how the agency can develop a more streamlined budget process for purchasing capital equipment. Currently, capital equipment for the agency is bought on a center-by-center basis, without much consideration to overall FDA expenditures for such equipment. "We're also looking at how to manage our payroll dollars" more efficiently, Holston added.
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