Congress easily passed a $1.1 trillion omnibus appropriations bill (H.R. 3547) to fund the federal government through Sept. 30. The 2014 budget bill provides increased funding for the Food and Drug Administration (FDA) and includes "directive" language to help guide implementation of the Food Safety and Modernization Act (FSMA).
Last month's smooth passage of the Ryan-Murray two-year budget package (P.L. 113-67) and this passage of the omnibus appropriations measure is a marked change from the ranker and gridlock that has been the norm on Capitol Hill for the past three years—especially in regard to fiscal matters like the annual federal budget.
The omnibus provides the FDA with $2.55 billion in non-user fee funding for fiscal year 2014, an increase of $91 million over the previous year. The omnibus also frees up $1.795 billion in user fees that have been previously authorized by Congress, bringing FDA's total budget for fiscal year (FY) 2014 to approximately $4.35 billion.
Under the budget bill, the FDA will also be able to access $85 million in sequestered user fee funding. Those funds, which will be spent on pharmaceutical, medical device, generic drug, animal drug, tobacco and food program, have been sequestered by the Office of Management and Budget as a result of Congress' inability to enact a new annual funding measure over the last year.
Congress' boost in FDA funding was well received by certain stakeholders who have been advocating for greater resources for the agency contending that FDA has not been able to fully carry out its mission in light of a vastly expanding set of public health responsibilities.
Congress also included "directive" language in the omnibus in regard to FDA's implementation of the FSMA. In addition to emphasizing the need for the agency to conduct proper training of federal and state inspection personnel, Congress voiced concern about FDA's proposed rule for Preventative Controls for Human Food (FDA-2011-N-0920) and encouraged the agency to re-propose that rule "based upon risk/cost benefit and other established verification controls." Congress also commends FDA for its decision last month to revise language from the draft FSMA regulations affecting farmers.
In summary, Congress urged FDA "to stay within the framework specified in law, ensure food safety rules are risk-based, and make certain that food safety improvements are economically feasible to both the agency and the industry."