US FDA Suspends Domestic Inspections As Staff Work Remotely In Covid-19 Response

The US Food and Drug Administration plans by 3 April to suspend all domestic good manufacturing practice surveillance and non-critical for-cause and pre-approval inspections for the duration of the novel coronavirus public health crisis as part of decision to require all eligible employees to work remotely

Exceptions will be made for inspections of facilities manufacturing medically necessary products, such as products to treat and prevent Covid-19, the disease caused by the virus, and breakthrough products such as cancer treatments.

CDC's Outbreak Data

The Centers for Disease Control and Prevention reported that through 4 p.m. EDT on 19 March:

• US Covid-19 cases: 10,442;

• Deaths: 150;

• Jurisdictions reporting cases: All states and Washington, DC, Puerto Rico, Guam, and US Virgin Islands.

FDA Commissioner Stephen Hahn announced on 18 March that the ban on most domestic inspections aligns with the White House Coronavirus Task Force and cross-government guidance directing employees to telework. The guidance is meant to "slow the spread of the crisis and help flatten the curve of the Covid-19 pandemic" through social distancing, he said.

"We must ensure our workforce remains healthy to carry out the FDA's critical public health mission to keep Americans safe," Hahn said.

He said the agency "postponed all domestic routine surveillance facility inspections" and it is evaluating all for-cause inspections and proceeding only if it deems them mission-critical.

This announcement follows up on the FDA’s 10 March decision to ban all foreign travel, including travel for meetings and inspections. (Also see "Coronavirus Slams US Consumer Health Industry Event Schedules, FDA Meetings, Inspections" - HBW Insight, 10 Mar, 2020.)

Alonza Cruse, director of the Office of Pharmaceutical Quality Operations in the FDA Office of Regulatory Affairs, said at 18 March conference prior to the agency's announcement that it is "scaling down and trying to wrap up surveillance inspections that are already in progress, and we are escalating those that are only the most critical for-cause and preapproval inspections.”

Speaking during the PharmaLink conference sponsored by the FDA and Xavier University in Cincinnati, which was conducted virtual-only mode, Cruse said the agency has been accused of being “tone deaf” in continuing to conduct inspections despite the epidemic gripping the nation. “We have a social responsibility to do whatever we can to reduce the transmission of COVID-19 and try to be socially responsible in our social distancing issues,” he said.