President Bush sent to Congress on Monday a 1992 budgetblueprint that proposes $197 million in fees chargedby the Food and Drug Administration to the drug, medicaldevice and seafood processing industries.

The proposed fees -- one side of a bigger answer to thebudget deficit that includes spending cuts -- include chargesfor the review of applications for new products.

The Bush proposal sets a total allocation for the FDA, includinguser fees, of $770 million, up 12 percent from the enactedbudget for fiscal 1991. Excluding user fees, the total allocationis $573 million, down 17 percent over last year.

One upbeat development for the FDA is that the 1992 budgetproposal includes a 6 percent increase in staff size from 1991.This is for an agency, which "for many years ... was asked to domore with less," Secretary of Health and Human Services LouisSullivan told a budget briefing Monday.

"We would very much like Congress to act on user fees thisyear," said Kevin E. Moley, assistant secretary for managementand budget. The provisions for FDA user fees in last year'sbudget request were blocked by Congress.

Although the proposed user fees were anticipated, "it isdisappointing that the allocation for direct funding does not atleast keep up with inflation," said Pamela Bridgen, executivedirector of the Association of Biotechnology Companies.

The FDA has yet to determine the precise fees under theproposal. It does expect that drug product applications wouldaccount for about $153 million of the total $197 millionin fees.

Bridgen said that the already underfunded FDA could befurther strapped for cash while it follows procedures fordetermining user fees. "One hopes that for small biotechnologycompanies there will be some exception or reduced fee," shesaid.

The president's 1992 budget request for the National Institutesof Health provided a 6 percent increase to $8.78 billion. AIDSresearch was pegged for a smaller rise of 3.5 percent, bringingtotal proposed expenditures to $1.95 billion.

-- Rachel Nowak BioWorld Staff

(c) 1997 American Health Consultants. All rights reserved.