FDA CONSOLIDATED CAMPUS SITE BIDDING will begin formally in November when the General Services Administration begins evaluating proposals for a unified FDA headquarters facility. According to a proposed timetable for acquiring a site, GSA says that it will establish a "formal site selection team" by Nov. 1. That group will be responsible for evaluating potential sites. GSA began advertising for sites in March, and the timetable states that GSA will continue to accept bids until Nov. 4. GSA anticipates that a short list of sites will be ready at the beginning of May 1992. The timetable projects that the final site selection will occur by Sept. 9, 1993 with a land purchase completed by Oct. 17, 1993. The eventual location of a consolidated FDA campus is emerging as an important issue for neighboring Montgomery and Prince George's Counties (Maryland) outside Washington. Currently, FDA headquarters is situated in Montgomery County, but more than a dozen new sites from both counties have already been proposed to GSA. Members of the Maryland Congressional delegation and local authorities from the two counties are maneuvering to promote their respective jurisdictions as the best site for the new FDA home. Among the legislators involved in the process are Rep. Morella (R), whose district includes Montgomery County, Rep. Hoyer (D), from Prince George's County, and Sen. Mikulski (D), a member of the Senate Appropriations Committee, who is pushing for congressional funding for the project. At an Aug. 5 meeting of the Montgomery County Council, Morella discussed the FDA campus proposal, taking an optimistic view of the GSA timetable for the project. "The site selection will be possibly within 12 months, eight at the very earliest," Morella said. However, she admitted that it "could even be 24 months before they even select a site." Morella pointed out that the consolidation will not be complete until the year 2013. A GSA development study projected that the first phase of the campus could be completed in 1997 ("The Pink Sheet" June 24, T&G- 14). The study determined that to meet FDA future requirements the campus would have to be 300-450 acres in size with 4.6 mil. square feet of facilities for a staff of 8,260. The total estimated cost for the campus is between $ 1.05 bil. and $ 1.35 bil. In listing the reasons why FDA's campus should be in Montgomery County, Morella pointed out that of the approximately 5,500 FDA employees, "54%, approximately, live in Montgomery County." Other advantages include the presence within the county of the National Institutes of Health, the Uniformed Services University of Health Sciences, and a large number of biotechnology firms. Prince George's County advocates are touting lower land costs as the key selling point to GSA. The House FY 1992 appropriations bill provides $ 2 mil. for site selection and planning and allows FDA to accept donations of land in either Montgomery County or Prince George's County ("The Pink Sheet" Aug. 5, p. 5). A Senate bill, the Department of Treasury, Postal Service and General Government FY 1992 bill (HR 2622), provides $ 200 mil. for planning and land purchase in Maryland. That bill was drafted by the Senate Appropriations/Treasury sub-committee which includes Mikulski. A House/Senate conference committee will begin work in September to reconcile the two appropriations bills.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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