New FDA guidance stresses necessary role of remote drug facility oversight during pandemic

The U.S. Food and Drug Administration (FDA) released new guidance this week to clarify how it will request and conduct remote interactive evaluations during the ongoing COVID-19 pandemic, noting how critical such evaluations will be to operations.

This was meant for any FDA-regulated facilities, for which inspections play a regular — and important — part in oversight. According to Acting FDA Commissioner Janet Woodcock, adaptation has been necessary to respect safety and still ensure drug quality, leading to a still increasing number of remote interactive evaluations.

“During this worldwide public health emergency, the FDA has used a variety of tools to oversee facilities that manufacture FDA-regulated products,” Woodcock said. “These tools include record requests in advance of or in lieu of a drug facility inspection, relying on information from trusted regulatory partners, and remote interactive evaluations (such as remote live streaming video of operations, teleconferences, and screen sharing). We have used some or all of these approaches to evaluate facilities for human and animal medical products during the public health emergency when inspections of drug facilities were not possible due to travel or quarantine restrictions.”

Among other things, the FDA guidance detailed the various interactive and virtual tools used in these evaluations. It laid out how the FDA will request and conduct remote evaluations at any facility where pharmaceutical products are manufactured, processed, packed, or held; facilities covered by the FDA bioresearch monitoring program; and registered outsourcing facilities. Any information gleaned from these evaluations will be used to update facilities information and address user-free commitments.

Any operation can choose to decline a remote facility evaluation, but the FDA warned this could delay a related evaluation or regulatory decision. No one will be able to request a remote evaluation from the FDA.

At the same time, Woodcock clarified that such remote efforts are not a replacement for inspections, and there will be situations where only a full inspection will do. Such situations are based on risk and history of compliance with FDA regulations. Even with remote operations, existing risk management methods and affiliated tools will be used to determine when to request participation in a remote evaluation.