FDA FY 1994 BUDGET OF $924 MIL. ADOPTED BY HOUSE SUBCOMMITTEE

FDA FY 1994 BUDGET OF $924 MIL. ADOPTED BY HOUSE SUBCOMMITTEE June 14, about $5 mil. shy of the $929 mil. requested by the Clinton Administration. The House Appropriations/Agriculture Subcommittee voted to provide $867.3 mil. for FDA salaries and general expenses, $48.6 mil. for facility rental payments, and $8.4 mil. for building costs. Full committee markup is scheduled for June 23. The House subcommittee approved the collection of $54 mil. in prescription drug user fees in 1993, as authorized by the Prescription Drug User Fee Act. The $54 mil. is included in the $924 mil. total. The subcommittee has a new chairman, Rep. Durbin (D-Ill.), but adhered to previous policy of not approving collection of user fees that have not been specifically established through congressional authorization. Thus, the committee did not agree to the Clinton Adminstration's request to collect about $200 mil. in fees on other FDA-regulated industries and use those funds to both enhance agency activities and reduce the federal deficit ("The Pink Sheet" April 12, p. 9). Congressional approval to begin collecting prescription drug user fees for FY 1993 remains unresolved. The House has approved a supplemental funding bill permitting FDA to begin collecting $36 mil. in user fees. A Senate committee-passed measure withholds that approval because of concern that FDA has made insufficient progress toward hiring additional staff to initiate the improvements in drug review activities that user fees are intended to help fund ("The Pink Sheet" June 14, p. 3). The Senate began floor debate on the measure June 17 and is scheduled to vote on it June 22. FDA has begun a study to develop "standard cost estimates" for the activities that will be supplemented with user fees. These estimates will be used to help set reduced user fee levels for companies such as small firms that are granted waivers from the general fees. The study will take another several months to complete but FDA hopes to issue a guidance on the criteria for obtaining waivers shortly, probably in tandem with issuing user fee invoices. At that time, FDA is also expected to release guidelines on when marketing applications may be bundled together and certain definitions of clinical data used for determining user fees ("The Pink Sheet" May 24, p. 12).