Food-safety, public health surveillance IT highlight FDA fiscal 2011 budget request

The Food and Drug Administration wants a 23 percent increase in its budget for fiscal 2011, in part to expand several information technology programs for food safety and public-health surveillance and monitoring.

Highlights in the budget are transformation of food safety practices, improved medical product safety, expanded patient safety initiatives and modernization of the FDA’s regulatory science, including nanotechnology.

Overall, the FDA is seeking $4 billion in fiscal 2011 to promote public health and safety, a $750 million increase from the current $3.3 billion.

More on this topic:

FDA Fiscal 2011 Budget Justification of Estimates for Appropriations Committee

New food safety initiatives would add $318 million, including new track-and-trace technology, improved data collection and risk analysis, according to the FDA’s budget justification submitted to Congress.

The FDA would spend $10 million in enterprise IT and for IT systems to establish, support, and maintain the systems necessary to collect Food Registration and Inspection User Fees.

The FDA also wants to spend $89 million to strengthen its processes for reviewing drug safety, including IT that supports human drug reviews.

Additional funding would be dedicated to the FDA’s IT infrastructure to enable interoperability of regulatory data sharing across the agency's program areas. The enterprisewide FDA IT systems include the Regulated Product Submission framework, the Janus program for a common data architecture, the Common Electronic Document Room and MedWatch Plus.

The FDA’s Sentinel Initiative would receive an additional $5 million, or nine full-time-equivalent positions. It is an effort to improve surveillance of postmarket product safety.