The US government shutdown means the country’s Food and Drug Administration (FDA) cannot accept new user fees, which means the agency cannot accept new medical product applications.
FDA commissioner Scott Gottlieb took to Twitter to highlight agency employees who are working unpaid to perform mission-critical activities. The FDA cannot legally accept any new medical device or drug submissions until the government shutdown ends because the user fees that are collected with these submissions cannot be processed during the lapse period. The agency is able to support activities funded by carryover user fee balances from the fiscal year 2018, but medical device user fee programmes only have about two months to three months left, and pharmaceutical user fee programmes have less than that.
The agency said it is continuing vital activities that are considered critical to ensuring public health and safety in the USA. These activities include: maintaining core functions to handle and respond to emergencies; supporting high-risk food and medical product recalls; pursuing civil investigations when public health is believed to be imminently at risk and pursuing criminal investigations; screening food and medical products imported to the country; and surveillance for significant safety concerns with medical devices and other medical products.
“You are valued each day,” Gottlieb tweeted to FDA staff. “But it is even more the case that in moments of challenge, when some of our work stops, that your critical role becomes so obvious. FDA cannot achieve its full mission without each of you; whether you are exempt, excepted, or on furlough. We are one FDA.”
“Thank you for your understanding and support,” replied a Twitter user with the handle Larry Stringer. “I am stuck at home, furloughed and reading your tweets. I cannot even look at e-mail to see what I am missing. I want to come back to work. I love my job and believe in our public health mission.”
Gottlieb warned: “It is not business as usual at FDA.”