FDA Prioritizes Public Safety during Government Shutdown

Posted January 16, 2019

The partial government shutdown, now the longest in U.S. history, represents “one of the most significant operational challenges in FDA’s [the Food and Drug Administration’s] recent history,” according to FDA Commissioner Scott Gottlieb via Twitter. In order to continue to fulfill its mission of “protecting the public health,” the agency is taking extraordinary measures to stretch its remaining budget by tapping into operations expenses and shifting funds generated by user fees.

“It is not business as usual at FDA. Many key functions aren't getting done,” Gottlieb wrote. “But we're focused on maintaining core activities that directly impact consumer safety and save lives. My priority is to our consumer protection mission and the people executing mission-critical functions.”

Those functions include monitoring for medical device adverse events, reviewing and processing recalls of high-risk and moderate-risk devices, and conducting for-cause inspections of device facilities “when the agency believes an imminent threat to life or health exists.”

To that end, the FDA has called back about 400 furloughed staff members, most of which are inspectors and inspection support staff. About 100 of them will focus on inspections of high-risk medical device manufacturing facilities, Gottlieb wrote.

“We were pleased to see the Commissioner’s statements and FDA’s policy announcement reaffirming that all critical public health activities would continue during the federal shutdown,” said Scott Whitaker, president and CEO of the medical device trade association AdvaMed. “We share FDA’s commitment to patient safety and monitoring.”

According to Gottlieb, the FDA is continuing work that was funded by 2018 user fees, such as those paid to obtain premarket clearance, if the product sponsor submitted the application and paid their fees before the shutdown began. However, the agency can’t accept or process new medical product applications or fee payments until the government reopens, Gottlieb said. The FDA has also halted reviews of pending applications for product categories that do not accept user fees, such as most blood or allergenic extract products.