FDA plans to restart domestic inspections, contingent on local coronavirus trends

Dive Brief:

Four months after putting most domestic inspections on hold due to the novel coronavirus, FDA has a plan to safely restart some on-site surveillance activities the week of July 20, the agency disclosed Friday.
Decisions on when to resume priority inspections will be made on a location-by-location basis, Commissioner Stephen Hahn said in a statement, taking into account data on outbreak levels in certain regions as well as state and local government guidelines. "In order to move to the next phase, we must see downward trends in new cases of COVID-19 and hospitalizations in a given area," Hahn said.
The agency will use a county-level rating system to determine whether a given part of the U.S. can handle a return to all regulatory activities, whether all inspections are OK with some caveats or whether only mission-critical inspections are appropriate.

Dive Insight:

The news Friday comes about two months after FDA shared in an update it was leveraging the White House guidelines on reopening and working with the Centers for Disease Control and Prevention to get inspections up and running again even as coronavirus spread continues.

The decision to resume some inspections, which FDA reiterated is guided by White House and CDC parameters, coincides with the U.S. this week passing the 3 million cases mark and 125,000 deaths, according to data compiled by the COVID Tracking Project.

FDA said it will equip its investigators with personal protective equipment and ensure they follow local, state and CDC guidance. And "for the foreseeable future," the agency will give businesses a heads up that an inspection is coming. Prioritized domestic inspections will be pre-announced, FDA said, so investigators and the regulated firm can ensure a safe environment and that necessary staff are on site, given that many companies still have some employees working remotely.

The agency will leverage the COVID-19 Advisory Rating system, which it said "uses real-time data to qualitatively assess the number of COVID-19 cases in a local area based on state and national data."

"We are also making the Advisory Level data available to our state partners who carry out inspections of FDA-regulated entities on the agency's behalf under contract," Hahn added.

Even without standard domestic inspections, FDA said it's had "great success" with alternative surveillance tactics like remote audits to monitor manufacturers.