The new omnibus appropriations bill that surprisingly sailed through Congress recently contains significant budget increases for the Food and Drug administration. Whether those increases will match FDA’s expanded responsibilities under the Food Safety Modernization Act (FSMA) remains to be seen.
The $1.1 trillion omnibus bill (HR 3547) funds the federal government through Sept. 30. In addition to fattening FDA’s coffers, the bill includes “directive” language aimed at helping to guide the implementation of FSMA, according to an analysis by the American Herbal Products Association.
Many observers have remarked that FSMA is the most profound change to the way food is regulated in the US since the institution of the Food Drug & Cosmetic Act itself in 1937. FSMA mandates new responsibilities for FDA, including ramped up inspections of domestic and overseas facilities. In the global, intertwined supply chain the law has implications for both food and dietary supplement companies.
“Last month's smooth passage of the Ryan-Murray two-year budget package (P.L. 113-67) and this week's passage of the omnibus appropriations is a marked change from the rancor 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,” AHPA said in a statement.
According to AHPA’s analysis, 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 $1.8 billion in user fees that have been previously authorized by Congress, bringing FDA's total budget for fiscal year 2014 to approximately $4.35 billion.
Freeing up sequestered funds
Like other federal agencies, FDA was affected by the sequestration process that took place during the partial government shutdown last year as lawmakers engaged in a game of political brinksmanship. Under the budget bill, 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 programs, had been sequestered by the Office of Management and Budget.
“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,” AHPA’s statement said.
In the ‘directive’ language portion of the bill emphasized the need for the agency to conduct proper training of federal and state inspection personnel. The bill also takes aim at the proposed Preventative Controls for Human Food rule, (FDA-2011-N-0920) asking the agency to re-propose that rule "based upon risk/cost benefit and other established verification controls.”
The wording of the bill goes on to say that FDA should "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."