FDA HUMAN DRUGS & BIOLOGICS FY 1989 APPROPRIATION IS $ 187 MIL.

FDA HUMAN DRUGS & BIOLOGICS FY 1989 APPROPRIATION IS $ 187 MIL., according to an agency-funding bill signed into law on Oct. 1 ("The Pink Sheet" Oct. 3, p. 3). The appropriation represents an $ 18.4 mil. increase over the fiscal 1988 level of $ 168.6 mil. In a draft explanation of the breakdown (see box below), FDA said the appropriation includes provisions for several AIDS projects. Congress approved $ 25 mil. to build an FDA facility for AIDS-related research on the campus of the National Institutes of Health, and it required the agency to use $ 2.5 mil. from prior year balances to make up the total. FDA noted that the provision, "in effect, reduces the amount available for planned repairs and renovations for other facilities." FDA FY 1989 APPROPRIATIONS The following appropriations breakdown is reprinted by "The Pink Sheet" from an agency prepared to Talk Paper. Dollars in millions; figures are rounded upward. In addition, FDA was given $ 40.4 mil. to fund other AIDS projects. Under another special provision, the agency noted that it has $ 4.9 mil. for orphan product grants. FDA pointed out that of its total 1989 budget of $ 531.4 mil., $ 481.8 is earmarked for salaries and expenses -- at a level of 7% higher than for the previous year. The amount provides for an increase of 150 full-time equivalents to 7,350. However, FDA noted that the legislation requires that the increase also be used to defray a pay raise scheduled for January 1989. The raise will absorb about $ 9 mil. of the $ 31.3 mil. increase. The HHS appropriations measure for 1989, also enacted Oct. 1 does not contain $ 80 mil. to fund vaccine injury compensation awards. Under authorizing legislation enacted in 1986, injuries from government-mandated childholld vaccines would be compensated from a trust fund with revenues from vaccine excise taxes; injuries that occurred before Oct. 1, 1988 were to be funded from four separate $ 80 mil. appropriations. House HHS Appropriations Subcommittee staff notes that the subcommittee had reached its spending ceiling before discovering it has jurisdiction for the pre-FY 1989 vaccine compensation claims. Consequently, according to the House report on the bill: "The committee has decided to permit payment of these retroactive claims from the trust fund in 1989. After it is known how much was actually required to pay these claims, an appropriation will be made to reimburse the trust fund." HHS reportedly has received almost 200 retroactive claims; however, the subcommittee staff points out that few claims are likely to reach settlement in fiscal 1989. Chart omitted.