If President Barack Obama and the White House have their way, the US Food and Drug Administration (FDA) could see a slight increase in its appropriated budget this next fiscal year.
On 4 March 2014, the White House's annual budget proposal was released to Congress and the public, in effect marking the Executive Branch's opening bid for the 2015 Fiscal Year.
Magic Numbers: $2.6 Billion, $4.5 Billion
The proposed budget calls for FDA to receive $2.6 billion in appropriated funding-that is, from taxpayers. An additional $2.1 billion in funding would be provided by user fees, such as those paid by pharmaceutical and medical device companies to submit marketing applications.
The agency's total budget of $4.486 billion would put it far above 2013 fiscal levels ($4.187 billion) but slightly below 2014 levels, estimated to be at $5.017 billion.
However, the agency's appropriated budget, which taxpayers fund, would grow under the president's proposal, from $2.561 billion in 2014 to $2.586 billion in 2015, or an estimated increase of $25 million.
Not all of FDA's regulatory centers would benefit equally from the increases. Food regulators would see an additional $20 million in funding, while drug regulators would see an additional $14 million. Device regulators with the Centers for Devices and Radiological Health (CDRH), meanwhile, would lose $3 million in appropriated funding for a total of $318 million-still $22 million above its 2013 appropriations, however.
The National Center for Toxicological Research (NCTR), FDA's regulatory science research outfit, would also see a slight budget cut from $62 to $59 million.
FDA's budget would see significant changes in the amount of user fees the agency expects to collect, though it is likely that this is due to the loss of certain one-time user fees collected under the Food and Drug Administration Safety and Innovation Act (FDASIA). Some of those fees went toward clearing backlogs, upgrading IT systems and other improvements.
FDA budget experts, including Steven Grossman of the Alliance for a Stronger FDA, called the proposed budget a positive for the agency, noting that it would see FDA's appropriated budget grow by 1% overall, with pharmaceutical and biological programs growing by about 2%.
However, Grossman said he had concerns as well. "While we welcome the increase and look forward to more details, we know that FDA will need a larger appropriation to carry out its activities in FY 2015," he said in an email to Focus.
In addition, he noted that the budget request included $259 million in proposed new user fees, including some that Congress had "chosen not to act upon in the past."
"Thus, a more accurate description is that the president's request is slightly over $4.2 billion plus proposed user fees that face an unknown fate."
The budget now goes to both houses of Congress, which will likely counter with their own respective budget plans.
White House Budget Overview for FDADetailed Line Budget for FDA (Page 431)