FDA INTERNAL ASSESSMENT OF RESOURCE NEEDS RECOMMENDED BY GAO

FDA INTERNAL ASSESSMENT OF RESOURCE NEEDS RECOMMENDED BY GAO in a September 15 report entitled "FDA Resources: Comprehensive Assessment of Staffing, Facilities, and Equipment Needed." According to the General Accounting Office: "Although FDA appears to need additional resources, it has not determined its needs on the basis of a comprehensive agencywide assessment of all FDA activities. GAO believes, therefore, that before the Congress can adequately consider FDA's staffing and other resource requirements, the agency should develop a strategy to assure that the resource requirements are adequately estimated." The GAO report, which has not yet been publicly released, was conducted in response to an Oct. 20, 1988 requests from the Senate Labor and Human Resouorces Committee and the Appropriations/Agriculture Subcommittee. The committees asked that GAO determine whether FDA's resource levels are adequate, and if not, to determine appropriate funding and staffing levels. GAO reports that FDA believes that it needs an additional 2,000 positions over its current staffing of approximately 7,229 fulltime equivalents in order to replace the staff lost since 1980, implement new statutory requirements and fulfill responsibilities pertaining to AIDS and the regulation of medical devices. In the Center for Drugs, GAO noted, "space problems have . . . led to recruitment problems at senior and other levels." The report adds that "in general, the center staff were working in offices that ranged in size from 62 to 179 square feet. Overall, FDA's staffing has declined from 7,816 in 1980 to about 7,229 in 1989. Despite the evidence that FDA's activities are constrained by resource shortages, the GAO auditors "found it difficult to substantiate FDA's estimate of its need for at least 2,000 more staff because FDA lacks uniformity in its internal management information systems." The estimate FDA provided "was based on partial information compiled from the judgmental estimates of senior FDA officials and from a variety of center and field office time and activity reporting systems," GAO notes. The agency does not "maintain a centralized system to allow it to determine total agency resource needs on an ongoing basis," GAO adds. GAO recommends that Congress require the FDA commissioner to "assess the agency's responsibilities and the staffing requirements to meet these responsibilities (based on present and future projections)." In addition, the commissioner should "determine the activities FDA can effectively undertake given a specified level of staffing increases," such as a 2% or 10% increase over 1989 levels. "Management changes FDA would implement to match specified staffing levels with higher priority responsibilities" also should be identified, GAO recommends.