For the first time in several years Congress has provided a budget for the U.S. Food and Drug Administration over and above increases requested for the salaries and expense account.

The biggest impact will result from the funding for the full pay raise of 4.6%. FDA's total program level is $1.4 billion and includes full funding for the Buildings and Facilities account as well as Prescription Drug User Fees Act and Mammography Quality Standards Act User Fees, and the Export Certification and Certification fund. The Salaries and Expenses Appropriation totals $1.345 billion, including $1.2 billion for Salaries and Expenses, and $161.716 million for PDUFA.

This budget reflects the commitment of the Administration and the Congress to continue strengthening the public health protection by focusing on urgent public health hazards. Here are some of the budget's highlights: * $15 million to protect consumers against the new variant Creutzfeldt- Jakob Dise ase, a fatal illness associated with consumption of meat from cows with bovine spongiform encephalopathy (BSE). The funds were provided to keep BSE, Mad Cow disease, out of the United States: * $10.3 million to prevent substandard food and health care products from reaching the U.S. market by increasing plant inspections and expanding surveillance of regulated imports; * $9.4 million to significantly upgrade food safety by expanding the highly successful Food Safety Initiative beyond microbiological contaminants to cover chemical and physical food hazards; * $10 million to safeguard patients against adverse events associated with the use of drugs, biological agents and medical devices by improving FDA's system for monitoring marketed products; * $10 million to protect the human subjects and research data in clinical trials by increasing FDA's inspections; * $10.1 million to enhance FDA's scientific potential and operational efficiency through infrastructure improvements. This includes funding for the development of an advanced financial management system, the completion of a new laboratory/office complex in Los Angeles, and the initial move of a FDA center. * $3.0 million for Dietary Supplements; * $2.5 million for generic drug review and education; * $1.0 million for Orphan Drug Grants and, * $0.5 million for a gene therapy data base; and * $3.0 million for activities related to antibiotic drugs. This article was prepared by Medical Letter on the CDC & FDA editors from staff and other reports.

From Newsrx.com