FDA Update - March 1999

FDA UPDATE - March 1999

Year 2000 Budget Proposal For the FDA

The FDA just released a copy of the President's budget proposal for the year 2000. The new budget calls for total resources of $1,350 million, which includes a $216 million - 18% - increase above the appropriations for FY 1999. This will represent the largest addition to the FDA's resources in the history of the agency, if it gets approved.

This budget increase is supposed to support the President's initiatives on food safety, youth tobacco preventation, and bioterrorism, and the implementation of the FDA Modernization Act of 1997 (FDAMA) in the three critical areas of injury reporting(MDR), product safety assurance and premarket application reviews as set forth in FDA's strategic Plan for Statutory Compliance issued last November.

In this proposed budget there will be $15.3 million for injury reporting. The MDR regulations will be a high priority for the year 2000.

$52.2 million will be allotted to increase the frequency of inspections across all product areas. The FDA will work toward the goal of inspecting each manufacturer every two years.

$11 million will be used to shorten its review times for the premarket approval of products not supported by user fees. The FDA has requested authorization to collect user of $7 million for medical device applications for new devices (PMAs), PMA supplements, and complex 510(k)s. What is considered to be a complex 510(k) and the type of user fees has not been determined yet.

$15.7 including $3 million in budget authority and $12.7 million in user fees for the Seafood Inspection Program.

Please be aware that this budget has not yet come up for a vote and for sure there will be many changes before the final one is passed. Please check here periodically for updates on the budget and the FDA initiatives for the year 2000.

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