WASHINGTON FDA Commissioner DavidKessler made his annual trek to Capitol Hill onWednesday morning and defended PresidentClinton's 1995 FDA budget before the Housesubcommittee on Agriculture, RuralDevelopment, FDA and Related Agencies. TheFDA's 1995 total budget request is for $988million: $645 million from general funds andauthority to collect $343 million in user fees.User fees collected from the prescription drugindustry would rise from the estimated $56million to be collected in 1994 to $79 million in1995.Under questioning by congressionalrepresentatives about the effectiveness of userfees, Kessler argued that proceeds from thePrescription Drug User Fee Act of 1992 hasallowed FDA to recruit 180 additional medicalreviewers to date. The agency has plans to adda total of 350 new reviewers. In addition, Kesslersaid that the user fee program has reduced thebacklog of new products awaiting review: from35 to six for drugs and from nine to three forbiologics.In his opening remarks, Kessler said that FDAapproved 370 new drug, generic drug andbiological product applications in 1993. Nine ofthe 370 approvals were for products designatedas orphan drugs (drugs for rare diseases).BIO Plugs FDA BudgetAlan Goldhammer, director of technical affairs atthe Biotechnology Industry Organization (BIO),testified later in the day before the same Housesubcommittee. He argued that a hiring freeze onGS-14 and GS-15 federal governmentemployment slots implemented as part of VicePresident Al Gore's Reinventing Governmentscheme, hampered full-speed implementation ofthe User Fee Act. Although the Department ofHealth and Human Services (HHS) lifted theFDA personnel ceiling, a pay level freeze is stillin effect, and Goldhammer claimed this made itdifficult for the FDA to recruit new medicalreviewers.We do not want to see the delicate contract thatwas entered into 18 months ago (the user feeact) abrogated, Goldhammer told thecongressional representatives. Unless FDA isprovided with sufficient resources in addition touser fee funds, they will fail in their mission toprovide the quality review that all parties expect.FDA Gets a New $900M HomeAccording to a front-page story in theWashington Post on Wednesday, $900 millionhas been set aside by the federal governmentfor a new 350-acre FDA research campus tohouse the agency's headquarters and drugresearch labs as well as a separate center forthe study of nutrition and veterinary medicine.The two new facilities will be located in Marylandand will house roughly 7,000 FDA employees.Construction may begin in early 1995. Plans forthe consolidation of FDA operations, which arecurrently dispersed among buildings andfacilities at 11 different locations in Maryland andWashington, D.C., were hatched more than fiveyears ago.031894Kessler
-- Lisa Piercey Washington Editor
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