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This article was originally published in The Tan Sheet

Executive Summary

FDA FY 1994 BUDGET OF $ 924 MIL. ADOPTED BY HOUSE SUBCOMMITTEE on June 14 is about $ 5 mil. shy of the $ 929 mil. requested by the Clinton Administration. The House Appropriations/agriculture subcommittee voted to provide $ 867.33 mil. for FDA salaries and general expenses, $ 48.57 mil. for facility rental payments, and $ 8.35 mil. for buildings costs. Full committee markup is scheduled for June 23. The House subcommittee approved the collection of $ 54 mil. in prescription drug and OTC switch user fees during fiscal 1994, as authorized by the Prescription Drug User Fee Act. The $ 54 mil. is included in the $ 924 mil. total. Although the subcommittee has a new chairman, Rep. Richard Durbin (D-Ill.), it adhered to its previous policy of not approving the collection of user fees if they have not been specifically established through congressional authorization. Thus, the committee did not agree to the Clinton Administration's request to collect about $ 200 mil. in fees on other FDA regulated industries, such as OTCs, medical devices and foods ("The Tan Sheet" April 12, p. 4). 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 approval to collect user fees in 1993 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 Tan Sheet" June 14, p. 15). The Senate began floor debate on June 17 and is scheduled to vote on the measure on 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 certain companies such those 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 Tan Sheet" May 24, p. 7).

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