FDA Requests Largest-Ever Budget Increase

On May 7, 2009, as part of the President’s fiscal year (FY) 2010 budget, the US Food and Drug Administration requested a budget of $3.2 billion, which is 19% more than the agency’s current budget. The requested budget includes increases of $295.2 million in budget authority and $215.4 million in industry user fees. If approved, the budget increase would be the largest in FDA’s history.

“This historic increase in the FDA's budget is a great investment in public health,” said Joshua Sharfstein, acting commissioner of food and drugs, in an agency press release. The FY 2010 request covers the period of Oct. 1, 2009, through Sept. 30, 2010.

The budget requests $166.4 million for a proposed Safer Medical Products initiative aimed at improving the safety of human and animal drugs, medical devices, vaccines, blood, and other medical products. Under the initiative, FDA will enhance oversight of the medical-product supply chain through traditional and innovative mechanisms such as inspections and field exams, integrated federal and state oversight, and greater access to international regulatory authorities’ inspection data and results. These enforcement activities are intended to improve industry compliance with FDA safety standards.

The Safer Medical Products initiative includes a proposal that FDA be granted authority to approve follow-on biologics through a regulatory pathway. (See a recent "Viewpoint" column, Industry Leaders Debate Follow-on Biologics Pathway.) The budget request also includes $5 million to help the agency develop policies to allow Americans to buy drugs approved in other countries.

In addition, the agency proposes $36 million in new user fees for the review of generic drugs and $10.5 million in new fees to reinspect facilities that fail to meet safety standards. FDA also requested $74.4 million more in current law user fees. These funds include an increase of $67.5 million to support agency review of new-drug applications, $2.3 million more for the review of animal drugs, and an additional $4.5 million for the review of medical devices.

In its justification of budget estimates, FDA said it would allocate its resources according to data-driven risk analysis. In FY 2010, the agency plans to inspect 700 foreign and domestic drug-manufacturing facilities it considers to be high risk, in contrast with the 600 inspections planned for FY 2009. The agency also plans 6197 drug-import field exams for FY 2010, more than twice the 2870 slated for FY 2009.

To identify high-risk facilities, FDA will use funds to improve the quality and quantity of product- and manufacturer-related data that it analyzes. The agency also plans to invest in modern information-technology systems and better analytic tools.

The Senate has scheduled hearings on the proposed FY 2010 budget for this week.