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Executive Summary

FDA CONSOLIDATED CAMPUS PLAN IS "SHORT-SIGHTED" in terms of space allocated for the number of employees that will be needed in the longer term, former FDA Commissioner Mark Novitch told an FDA Council congressional briefing on June 24. "In the planning I've seen," Novitch said, "I'm not sure that the numbers of full-time equivalents that the FDA estimates that are needed are encompassed" by consolidated campus proposals. Novitch characterized the limited space allocated as "planning more short- term space straight off." HHS Secretary Sullivan testified at a May 15 hearing before the Senate Labor & Human Resources Committee that he has authorized FDA Commissioner Kessler to initiate planning for a consolidated campus ("The Pink Sheet" May 20, p. 11). A recent General Services Administration study has estimated that FDA in the year 2000 will require 300-450 acres and 4.6 mil. square feet for a staff of 8,260 ("The Pink Sheet" June 24, T&G-14). Novitch, an Upjohn vice chairman, was one of three former FDAers now in industry who discussed FDA's infrastructure needs at the industry-based advocacy group's briefing. Joining Novitch were former FDA Associate Commissioner for Legislative Affairs Hugh Cannon, who left the agency June 15 to join Glaxo, Inc. as director of federal agency relations, and Marty Rose, a former medical officer in FDA's Division of Cardio-Renal Drug Products and current Genentech senior director of government affairs. Cannon discussed what he called the "niggling" transition to reality from the plan for the unified campus envisioned in Sen. Hatch's (R-Utah) 1990 FDA Revitalization Act. He asked: "How do we get there from here? How do we get the money? Where's it [the campus] going to be [located(BRACKET)?" The law authorizing the campus idea does not include funding. Cannon differed with Novitch in his assessment of expansion plans, however, saying that "some of the plans I've seen will allow for that kind of growth. These plans don't call for just one or two buildings, and lumping everyone together." Rose, discussing his tenure at FDA, recalled that by the time he left the agency in 1988, "there was no space at all. They had authority to hire people, they had medical reviewers who wanted to come in and review drugs for AIDS, but they couldn't bring them in because there was no place to put them. They tried having reviewers work in shifts, they gave reviewers applications to take home and review . . . Dr. Peck was really upset because he could not bring people in." In addition to "constantly scrounging for space," Rose also reported a lack of adequate data and communications machinery, saying that "much of the computer equipment we had was donated by industry . . . in connection with an electronic NDA." He added that "one of the goodies for taking part in the electronic NDA experiment was that you could get a computer on your desk that you could have for the year of six months or whatever it was that it took you to review the NDA." Novitch also recalled this situation, saying "I would feel embarassed that the agency has to accept equipment and systems from the applicant. The agency ought to be in charge, and leading the effort toward the automation of New Drug Applications." Attending the meeting were staff representatives from the House and Senate Appropriations Committees on Agriculture, the Senate Labor & Human Resources Committee and the House Energy & Commerce Committee. Also attending were representatives from several of FDA Council's member-companies, including Upjohn, Monsanto, Synthecell, and Genentech. The June 24 briefing was the FDA Council's second in a series on the need for increased FDA resources. A third briefing is expected to be held during the summer or by early September.

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