January 22, 2018
Congress’s failure to pass a government spending bill last weekend means much — but not all — of the FDA’s work will stop until the government is funded. Firms should be aware that scheduled meetings with FDA will more than likely need to be postponed and rescheduled, said Steven Grossman, deputy executive director of Alliance for a Stronger FDA. “Certainly, medical product companies with near-term expectations — review meetings, initiating clinical trials, etc. — are faced with the possibility of slippage in their development timelines,” he said.
U.S. Government staff who work on activities that involve “the safety of human life” are expected to keep working — and many FDA activities can fit this characterization. Adverse event reporting for all products, recall reviews and potential recall decision-making, etc., will continue, said John Avellanet, managing director and principal consultant at Cerulean Associates. “Anything that could directly impact public health will continue,” he said.
“Under a shutdown, two out of five FDA employees are furloughed,” said Wayne Pines, president of healthcare at APCO Worldwide. A 2018 Department of Health and Human Services shutdown contingency plan states that many of its workers would be immediately furloughed, including all food inspectors, but some activities will continue.
For example, routine establishment inspections are now on hold, said Avellanet. “FDA will make a decision later, pending how long the shutdown is, whether to postpone, conduct abbreviated, or skip any missed routine inspections,” he added.
Avellanet noted that for-cause, whistleblower and safety signal inspections will continue as normal.
FDA personnel whose work is funded by outside user fees, such as PDUFA, would be able to keep working. But Grossman noted an important caveat: “Most product review programs are a mix of taxpayer and user fee funding, so will be staffed but not fully staffed.”
During the 2013 government shutdown that lasted 16 days, the FDA published a notice that stated it would continue to accept and proceed with reviews for any submissions that the agency received user fees for before the shutdown. The FDA also published notices in 2013 announcing which activities would continue and which would stop until the funding issue was resolved.
But there is still hope that the impasse can be resolved quickly. “We do not think a shutdown will extend beyond the coming week (five missed days), but there is no doubt that a longer shutdown will have a proportionally greater impact on the agency,” said Grossman.
All requests for comments to the FDA were referred to the Office of Management and Budget, which did not respond to requests for comment.