FDA “People Power” Could Take Sequestration Hit – Hamburg
This article was originally published in The Tan Sheet
Executive Summary
The FDA commissioner says a budget sequester would slow implementation of FDA Safety and Innovation Act provisions and reduce some overseas inspections. More emphasis could be placed on using systems that target the riskiest facilities to reduce the number of onsite inspections, Hamburg says.
FDA Commissioner Margaret Hamburg warns against allowing the budget sequester to be implemented and hints at potential effects of cuts on the agency.
Hamburg told a meeting of the Alliance for a Stronger FDA Feb. 5 that the cuts could reduce facility inspections and slow implementation of user fee and other programs. She also reminded the advocacy group that the agency relies on personnel more than other agencies to implement and run its programs.
“It’s a lot of exciting and important work, but it requires that we have the depth on the bench, the expertise, of course scientifically, and the sheer people power to support these efforts,” Hamburg said.
FDA Commissioner Margaret Hamburg
Photo courtesy of FDA
If not prevented, sequestration is expected to result in about $319 million in cuts to the FDA budget, including user fees. There also is potential for hiring to be delayed or layoffs required with the sequester in effect (Also see "FDA Taking “Risk-Based Approach” To Sequestration Cuts" - Pink Sheet, 15 Oct, 2012.).
FDA has been tight-lipped about its specific plans for dealing with sequestration. But Hamburg gave a clue, saying the agency would perform about 2,100 fewer domestic and foreign inspections of food facilities.
She said she hoped a lot of personnel actions would not be necessary, but said some activities would be limited, especially international inspections due to their significant cost. She said more emphasis could be placed on using systems that target the riskiest facilities to reduce the number of onsite inspections.
The cuts likely would hurt FDA efforts to deal with industry globalization and work with other trusted regulators to share the inspection workload. FDA wants to use information from the European Medicines Agency and others, which would allow the agency to better focus its resources (Also see "Collaboration On Foreign Inspections Helps FDA Improve Resource Allocations" - Pink Sheet, 15 Aug, 2011.).
FDA Is “Lean” But “Robust”
The agency already implemented initiatives intended to cut costs, such as increasing telework and reducing travel and other budgets.
FDA also now uses the office “hoteling” concept, in which employees do not have a permanent work space, Hamburg said, adding that the agency is looking at contracts to reduce service duplication.
“We’re lean, but we’re in robust, good health. We need to really look for every opportunity that we can to streamline our activities and leverage our resources, but we cannot walk away from our critical roles and responsibilities.”
Regardless of sequestration, implementation of critical programs will move forward, the commissioner said. However, she added that implementation of FDA Safety and Innovation Act programs may slow under sequestration, which could prevent fulfilling commitments to industry made in user fee agreements.
“I am very concerned about our ability to engage as fully as we might otherwise,” Hamburg said. “We’re going to have to prioritize in some important ways, but we don’t see stopping elements. We will not make our targets. That’s almost a given.”
President Obama earlier the same day asked Congress to pass a short-term sequester delay that included spending cuts and tax reform and to allow more time for negotiations to replace the cuts and avoid damage to the economy. However, Democratic and Republican leaders are trading accusations of failing to cooperate on budget legislation and as of Feb. 8 no proposal for federal appropriations through the remainder of fiscal 2013 had gained momentum in Congress.
The across-the-board cuts loom as a result of the failure of the Joint Select Committee on Deficit Reduction to find $1.2 trillion in cuts over 10 years by a November 2011 deadline. Congressional leaders agreed to the threat of sequestration to force a deal on deficit reduction. The cuts were set to go into effect Jan. 2, but a congressional deal near the end of 2012 averted the cuts until March 1 (Also see "In Brief" - Pink Sheet, 7 Jan, 2013.).