In its funding request the US Food and Drug Administration (FDA) said it wanted $1.7bn for the 2009 fiscal year but the Omnibus Appropriations Act has proposed $2bn. This direct funding will be supplemented by around $600m in industry user fees.
Funding for medical product safety has risen by $114m, which dwarfs the $21m increase the FDA was initially given in 2008. However, this amount rose by $58m throughout the year as extra funds were allocated.
The additional funding for 2008 was provided in response to concerns about the FDA’s ability to protect consumers, with the heparin contamination highlighting the dangers of a global supply chain and the difficulties in policing it.
In response to the scares of 2008 the Act calls on the FDA to use the funding to significantly increase foreign and domestic facility inspections.
This is one of the primary objectives outlined in the Act, which also requests that the FDA: “Establish a unique device identification system to track devices, facilitate recalls, and support inventory management.”
In addition the agency has been told to improve its laboratory infrastructure and rapid analysis tools, which will provide capacity for the significant increase in analyses and several thousand import exams and samples the Act envisages.
Further efforts are called for to tighten up borders, including the development of a regulated product information data warehouse, which can be shared with other agencies.
Complementary to this is the integration of risk-based information into data systems to improve electronic screening of imports. This should allow the agency to proactively identify problems and risks associated with imported products.
These measures will be underpinned by improvements to the agency’s IT infrastructure, which the Act believes will enable data sharing and enhanced analysis of adverse events.
The Act is being proposed now because last year nine bills were left unfinished after President Bush and Congress were unable to reach a compromise. A debate is scheduled for later this week to discuss the Omnibus Appropriations Act.