Approximately 400 employees at the FDA are being called back to work amidst the partial U.S. government shutdown, most of which will engage in key inspections or support inspectors, according to a series of tweets from FDA Commissioner Dr. Scott Gottlieb posted yesterday.
Approximately 100 of those 400 recalled workers will focus on inspections of high risk medical device manufacturing facilities, with an additional approximately 90 individuals focused on high risk biological manufacturing facilities, Gottlieb said. An additional 70 employees will focus on high risk drug manufacturing facilities.
The largest group, approximately 150, will be focused on food inspections, Gottlieb tweeted.
The partial government shutdown, currently the longest in U.S. history, resulted in the furlough of approximately 40% of the FDA’s staff, about 7,000 of an approximately 17,000 employees.
Essential public health employees have remained at work, as well as activities covered through the agency’s user fee programs – though Gottlieb warned in a separate set of tweets that user funded programs do not have an endless runway to continue.
For medical device companies, those that have already submitted an application and paid their required fees will continue to see their applications reviewed, Gottlieb said in a series of tweets on Monday.
“However, during the lapse, FDA cannot accept new medical product applications that require a fee payment. We are not allowed to accept new user fees. In these cases, sponsors will need to wait until the lapse is over to submit their applications to FDA for review,” Gottlieb said in a series of tweets.
The Medical Device User Fee Amendments program has a runway of approximately two to three months, Gottlieb said earlier this month.
The agency’s Prescription Drug User Fee Act is the “most vulnerable program” during the shutdown and will run out of funding first, Gottlieb said. He added that the funds will cover the agency into February, “but how far into Feb is still very fluid.”
“We’re trying to free resources to extend its runway. We said 4/5 weeks counting this week. That could change but is our rough estimate right now,” Gottlieb said in a tweet.
The Generic Drug User Fee Amendments program has approximately one to two months of funding left, Gottlieb said.
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