US Congress boosts FDA funding by $325 million
This article was originally published in Scrip
The US FDA will get a $325 million appropriations boost in the current fiscal year now that President Barack Obama has signed omnibus legislation funding the federal government through to September 30th.
The agency will receive a direct appropriation of $2.04 billion this year, a 19% increase over the $1.71 billion enacted for fiscal 2008. The measure also includes $583 million in user fees, with almost $511 million coming from prescription drugs. The fees bring total agency funding to $2.62 billion for fiscal 2009, a 16% increase over last year.
Congress was unable to complete its appropriations work before adjourning last year. Since October 1st most federal agencies have operated under a continuing resolution that held funding at fiscal 2008 levels. However, FDA funding under the continuing resolution included an extra $150 million in supplemental monies approved last summer.
The House passed the 2009 omnibus appropriations bill last month, and the Senate cleared the measure on March 10th. It was signed into law by the president the following day.
The FDA's drugs centre and its related field activities will receive total funding of $777.4 million, a 14% increase, with at least $41.4 million dedicated to the generic drugs office. The biologicals centre and its field activities will receive $271.5 million, an increase of almost 15%.
improvements
Congress increased the agency's budget by $145 million, or 9%, in 2008, and later added the $150 million in supplemental funding. With the additional $325 million included in the fiscal 2009 omnibus, the FDA will have received $620 million in new funding over the past 16 months, according to the Alliance for a Stronger FDA, a coalition of stakeholder groups that has pushed for increased agency funding.
"It is expected that these substantial funding increases will lead to significant improvements in food and medical product safety," House lawmakers said in a report accompanying the bill. "The FDA should also build on these improvements by taking broader approaches to addressing safety issues".
The measure provides a $114.2 million increase for medical product safety, including drugs, devices and biologicals, with a focus on increasing regulatory oversight of foreign manufacturers and bolstering information technology tools.
The agency is to use the additional funding to increase foreign and domestic facility inspections, improve rapid analysis tools, and conduct more laboratory analyses and import exams, the report said. The funding is also targeted for implementing FDA Amendments Act safety provisions, upgrading information technology to enable data sharing and enhanced analysis of adverse events, developing a regulated product information data warehouse and integrating risk-based information into data systems to improve electronic screening of imports.
"Similar to a recent approach the FDA has taken to address overall food safety issues, the FDA is directed to prepare and provide to the committees on appropriations a comprehensive approach to ensuring the safety of medical products from the manufacturing of raw ingredients or components to consumer use," the report states.
The measure provides $16 million for the Critical Path initiative and a $6.62 million increase for the drugs centre's advertising review division. This is equal to the amount of user fees that would have been generated under the direct-to-consumer television commercial advisory review programme, which was part of the 2007 reauthorisation of the Prescription Drug User Fee Act but never funded by Congress.
The report encourages the agency to prioritise review of new treatments and clinical trials for paediatric oncology patients and to provide a report on these activities.
Lawmakers seek to ensure that the FDA is efficiently applying the new funding to its most pressing needs. The agency must provide Congress with quarterly expenditure reports detailing the number of new hires and their estimated costs, the number of inspections and their estimated costs, and information technology acquisition and development spending.