Bioequivalence and Bioavailability Forum

Senior Food and Drug Administration leaders are planning for cutbacks to the number of routine food and drug inspections conducted by the agency […]
Around 170 workers were cut from the FDA’s Office of Inspections and Investigations […]
The inspections and investigations office will now need to work with FDA’s drug, device and food centers to reprioritize their workload for the rest of the year, one official said. That will mean trimming routine “surveillance inspections” for more urgent tasks […] like inspections of firms where the agency has been alerted to a safety risk or follow-up visits to ensure that drugmakers or food producers have fixed previous violations.
One of the biggest immediate impacts on the agency’s inspectors stems from the elimination of the office’s travel operations division, one official said. The team’s work ranged from booking flights to coordinating with the State Department to secure translators needed for inspections of drugmakers and food producers abroad.
“As of yesterday, all front-lin­e investigators will now be spending significant time processing their own travel and related ad­mi­ni­strative requirements, rather than spending that time in firms ensuring the American consumer is protected,” one FDA official told CBS News.
A pilot program of unannounced foreign inspections has also been paused due to the cuts, an official said, because of the loss of staff that had been tasked with quickly securing translators around the world.
While current inspections are still taking place, multiple FDA officials said that cuts are likely to worsen delays caused by other challenges introduced by the Trump administration’s efforts to cut spending in recent months.
As one example, multiple officials said that field operations have been hampered by a new government-wide $1 limit on spending cards. Any spending above that limit requires a cumbersome approval process.
     Alexander Tin @CBS News