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FDA PLANNING $3 MIL. MANAGEMENT INFORMATION SYSTEM DESIGN CONTRACT AS PART OF MOVE TOWARD AUTOMATION OF PRODUCT REVIEW DATA, COM. KESSLER TELLS HOUSE

Executive Summary

FDA is planning to award $3 mil. in outside contracts during FY 1993 as part of its effort to improve management information systems and, in particular, to automate drug product reviews, FDA Commissioner Kessler told the House Appropriations/Agriculture Subcommittee March 24. Kessler said the agency proposes "to use $3 mil. of these funds requested [in FDA's fiscal 1993 budget plan] to contract for expertise to assist us in the documentation of user needs and systems requirements in our drug and biologics programs, as a beginning of this long-term project" to improve the agency's management information systems. FDA's FY 1993 "Justification of Appropriations" report to Congress explains that "initial work will be done on systems analysis, system design and system integration" in the Centers for Drug Evaluation and Research and Biologics Evaluation and Research. FDA "proposes to use approximately $3 mil. to contract for systems expertise to assist in the areas of data architecture, file structure development, nomenclature standardization and user interface." The document notes that pilot projects by the CDER and CBER have provided "substantial evidence that automated application submissions can greatly facilite FDA reviewers ability to analyze data and submissions; can improve communications between sponsors and the agency; and can reduce review time." While the project is aimed largely at improving the information systems related to product reviews, its scope is wider. Another goal, for example, is to better integrate field and headquarters staff operations. The management information systems initiative is one of the few new projects highlighted in the budget justification document. Overall, FDA's plan to spend $791 mil. in FY 1993 would maintain the current level of operations by providing about a 4% increase from FY 1992 ("The Pink Sheet" Feb. 3, p. 13). During the hearing, Kessler did note the "challenge" presented by the growing influx of product applications in biotechnology area and the need to "go the extra mile" to help some of the smaller biotech companies to comply with regulatory requirements. The budget justification document states that in "1993 FDA will continue to expedite the transfer of these advances from the laboratory to the marketplace through use of an increased review staff, expanded research, development of information packages for industry and implementation of a 'user friendly' program to assist manufacturers with the scientific regulatory aspects of product development, manufacturing and marketing." The spotlighting of biotechnology aside, FDA's biologics budget is proposed to receive a slightly smaller increase than some other areas. The $98.68 mil. budget for biologics is a 3.45% increase from FY 1993, compared to increases of 4.4% for human drugs, 4.23% for medical devices and 5% for foods. However, the Bush Administration is proposing to raise only 12% of the biologics budget from user fees, versus 25%-33% of the budgets for human drugs, medical devices and foods. Kessler recently announced plans to hire 50 additional biotech reviewers; funds for those new personnel appear to be built into the biologics funding increase between 1991 and 1992 ("The Pink Sheet" March 9, p. 18). FDA is proposing no increases in full-time equivalent staffing positions in either the agency as a whole or in individual program areas, following large increases between 1991 and 1992. FDA is proposing a staff of 2,412 FTEs for the human drugs program and 932 for the biologics program. Despite FDA's tight budget, Kessler assured the subcommittee that the agency is still able to attract qualified personnel due to these individuals' sense of public service and belief in FDA's mission. "But there are things we can do" to help the recruitment effort, he acknowledged, including improving both salaries and facilities. "When you recruit and bring somebody in [to the agency] you don't want to be embarrassed" by the physical facilities, he remarked. "We're making enormous progress on that." The agency is moving forward with plans to create two campuses in the Washington, D.C. metropolitan area that will consolidate 11 different FDA facilities and 5,400 employees. Last September, House and Senate conferees approved $197 mil. in funding to acquire land for the project ("The Pink Sheet" Oct. 7, 1991, T&G- 1). Subcommittee Acting Chairman McHugh (D-N.Y.) questioned whether the $791 mil. budget request would suffice. He told Kessler that despite an "impressive" FDA staff and aggressive program management, "I'm left with the feeling that resources... which are being requested by your agency will not really be sufficient to help you meet the mandate." McHugh commented: "I know you're in a position where the budget request is something you must defend, but frankly the demands on you, imposed in some cases by Congress, are increasing. Your budget request is about 4.3%, I think, which includes $200 mil. in user fees which are problematic. In addition, you've indicated that you're going to probably have to spend significant additional resources on biotechnology and on [implementing] the Safe Medical Devices Act of 1990. That would suggest to me that some other areas are going to be squeezed." These considerations, McHugh added, indicate "that certainly, if not in the 1993 fiscal year, beyond that additional resources will be required."

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