Posted 08 February 2013
By Alexander Gaffney, RF News Editor
White House officials are backing up a number of allegations made by several industry watchers regarding the effects of budget sequestration on the US Food and Drug Administration (FDA), noting that, among other things, the cuts could negatively impact drug review times and regulatory science.
On 1 March 2013, federal agencies are scheduled to run into the effects of budget sequestration, which calls for annualized budget cuts of approximately 8% for all domestic non-defense agencies, including FDA.
Those cuts would be required-if they do come into effect-by the end of the year. Steven Grossman, an industry analyst who writes for the advocacy blog FDA Matters, wrote in a recent posting that this would means cuts of more than 5% of FDA's budget, or approximately $200 million.
White House: FDA Approvals Delayed
In a posting on the White House's website on 8 February 2013, press officials said that, "The FDA's Center for Drug Evaluation and Research (CDER) would face delays in translating new science and technology into regulatory policy and decision-making, resulting in delays in new drug approvals."
But the agency faces more immediate concerns as well, the Obama administration argued.
"The FDA would likely also need to reduce operational support for meeting review performance goals, such as the recently negotiated user fee goals on new innovative prescription drugs and medical devices."
Those user fee goals, negotiated under the FDA Safety and Innovation Act (FDASIA), would boost FDA's funding by several hundred million dollars over the next few years. The sequester, however, would seize some of the money, leaving FDA with the same enhanced review times but without the money to implement structural enhancements to improve its review capabilities.
Inspections would likely be impacted as well. The White House argued that FDA could conduct 2,100 fewer inspections of domestic and foreign food production facilities. That would likely mean similar reductions for FDA's drug and device facility inspections. Those cuts, the White House explained, could increase the number and severity of safety incidents.
But staff, more than any other entity, could feel the deepest cuts. A similar regulator, the US Department of Agriculture's Food Safety Inspection Service (FSIS), which as of 2009 employed approximately 8,000 staff, would likely need to furlough all staff for about two weeks, the White House claimed. FDA, which employs nearly double the amount of staff as the FSIS, would likely need to make similar furloughs to maintain its basic operations, analysts have said.
The White House isn't the only entity making such claims, either. A recent report published by the Democrats of the House Committee on Appropriations adds another source of concern: FDA doesn't regulate a static industry.
Again looking at food, the committee finds that food imports have grown annually at 10% each year. If FDA's budget is held, or even decreased, under a sequestration scenario, its comparative ability to regulate mounting imports of food and other types of products would be vastly reduced.
The report pointed to a 2011 FDA report that estimated that imports of FDA-regulated products-drugs, devices and food-will grow at an average rate of 15% per year. Regulators have already noted difficulties in inspecting imports and foreign-based facilities, and cuts could make inspectional parity between US and foreign inspections that much harder to achieve.
The White House's lengthy salvo comes just days after news reports that the White House had effectively gagged heads of agencies from talking about how the cuts would specifically impact their agencies, which reports suggested had frustrated agency officials and some legislators in equal measure.