FDA Struggles with US Government Shutdown
The US Food and Drug Administration (FDA) is recalling furloughed employees to carry out inspections as the longest-ever US government shutdown moves toward its fifth week.
Commissioner Scott Gottlieb said earlier this week about 400 staff would immediately begin examining the safety of drugs, biologics and medical devices. The commissioner himself is stepping in to handle public affairs with many staff still stuck at home, mostly without pay.
Around 260 of the 400 recalled employees are handling medical product inspections, 90 for biologics, 70 for drugs and 100 for medical devices, and the remaining 140 are food inspectors and support staff, the commissioner said.
Due to the extended Christmas and New Year holidays, very few, if any, inspections have been missed, the commissioner appointed last year by incoming President Donald Trump insisted.
Gottlieb said some user fee-supported programs are using carryover fees to keep operating but some, including those built around the Prescription Drug User Fee Act program (PDUFA), were running out of steam.
The law dating from 1992 allows the FDA to collect fees from drugmakers to fund the approval process; however, to continue collecting, the FDA is required to meet certain performance benchmarks, primarily related to the speed of the review process.
The agency is now focused on the core aspects of its consumer protection role, Gottlieb told US media, adding that the FDA is focused on preserving the function of itd programs for as long as possible.
The current government shutdown began on Dec. 22 2018, when the new US budget for 2019 was not approved because the House of Representatives declined to accept the president’s requested $5.7 billion allocation for a wall along the Mexican border.
