FDA resumes some drug inspections halted by US government shutdown

Approximately 160 FDA employees will be resuming work beginning Tuesday in the agency's drug inspection area, according to FDA Commissioner Scott Gottlieb. Employees returning to work, mostly without pay, include about 70 staff focused on inspections of high-risk drug manufacturing facilities and roughly 90 focused on inspections of high-risk biological manufacturing facilities. 

Gottlieb noted that the return of inspectors to work represents a "major functional accomplishment" for the FDA, adding that approval for the move was granted last week by the Office of Management and Budget and the Department of Health and Human Services. The Commissioner also stated that he received an "overwhelmingly positive" response from inspectors regarding the prospect of returning to work without pay.  

Around 60 percent of the FDA's activities, including drug reviews, are funded by user fees from the industry. Meanwhile, Gottlieb recently warned that funds for these activities, which cannot be collected during the government shutdown, could be exhausted in the coming weeks.  

Despite the news, RBC Capital Markets analyst Brian Abrahams warned "with the FDA unable to accept new user fees and existing carryover funds reportedly only expected to last for several more weeks, we expect drug manufacturers could face near-term regulatory gridlock and the potential for a backlog of delayed filings, meetings, and regulatory decisions that could extend even beyond the end of the shutdown." 

Earlier this week, Aimmune Therapeutics disclosed that the FDA's review of the investigational therapy AR101, which was submitted for approval last month for the treatment of peanut allergy in children, will be delayed as a consequence of the government shutdown.  

Meanwhile, the FDA separately announced on Tuesday plans to eventually hire 50 new reviewers to oversee the clinical investigation, development and review of cell and gene therapies. 

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