WASHINGTON _ When President Clinton sends his formal budgetto Capitol Hill in mid-March, user fees will again be at the forefrontof the debate over funding levels for the agency.

While the Biotechnology Industry Organization (BIO) andPharmaceutical Research and Manufacturers of America (PhRMA)support user fees, the Health Industry Manufacturers of America,whose members include manufacturers of biotech assays anddiagnostic products, is strongly opposed to these user fees, accordingto an association spokeswoman.

FDA's current budget expires on October 30, 1996. Unlike manyother federal health agencies, which are operating on temporaryspending authorities, the FDA's budget is part of the Department ofAgriculture funding bill which was passed by Congress last fall.

During the debate on the FDA fiscal 1996 budget, the Republican-controlled Congress rejected the administration's request to imposeuser fees on the review of medical device applications, whichincludes biotech diagnostics products.

User fees have been collected by the FDA since 1992 to finance theadded cost of drug applications reviews and system improvements.

In addition to nixing the FDA's request for user fees for medicaldevices, Congress last fall stopped the agency from consolidating itsoffices that are strewn over several counties in the Washington areaonto a single campus. Also rejected by Congress was a $15 millionrequest to improve inspections of items imported under itssupervision.

While other domestic spending programs faced significant cutbackslast year, Congress was relatively generous with the FDA, holding theagency's overall spending relatively flat in the last three fiscal years.Congress appropriated $878 million in fiscal 1996 budget authority,not including nearly $102 million user fees collected by the agency.In fiscal 1995, the agency received $888 million in budget authority;in fiscal 1994 $873 million.

The White House on Monday submitted a truncated budget for fiscal1997 that was excerpted from the administration's alternative deficitreduction plan that President Clinton submitted to CongressionalRepublicans in early January. No specifics were contained in thisstatement. The unusual one-page budget submission met statutoryrequirements that the President submit his budget to Congress in thefirst week of February.

A fiscal 1997 budget request, however, will be released in mid-March that will detail spending plans for all federal agencies. TheMarch budget request also will detail the President's stand on capitalgains and other tax issues. n

-- Michele L. Robinson Washington Editor

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