The Food and Drug Administration (FDA) issued new guidance on inspections during the COVID-19 pandemic, as the agency began to resume domestic inspections in July.
According to the 12-page guidance for industry, titled, “Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers,” inspections were temporarily postponed in March but are resuming for prioritized activities in the United States. (The guidance is available at: https://www.fdanews.com/ext/resources/files/2020/08-19-20-COVID19ManufacturingInspectionsQA.pdf?1597864583.)
The FDA is using a COVID-19 Advisory Rating system to determine what categories of regulatory activity can take place in any particular region. Using this determination on a case-by-case basis, the FDA will conduct mission-critical inspections or resume prioritized domestic inspections, including preapproval and surveillance inspections, according to the guidance.
“Resumption of these domestic inspections is being done consistently with the National Guidelines for Opening Up America Again,” the FDA wrote. These inspections are preannounced to sites to ensure the safety of investigators and others.
When IRBs and research sites are contacted by the FDA about an inspection, they possibly can postpone it, depending on their circumstances, says Chris Weir, CIP, IRB operations manager at Fred Hutchinson Cancer Research Center in Seattle.
“I was aware of another IRB contacted by the FDA. They said, ‘We’re in the middle of a pandemic here, and [the inspection] won’t work right now,’ and the FDA said, ‘No problem; we’ll call you back in a few months,’” Weir recalls. “They were willing to delay a routine audit.”
In-person inspections can be problematic for research organizations that still do not have their full staff working onsite, he notes. For instance, at Fred Hutchinson Cancer Research Center, all the administration has been off-site, even though the IRB is still in a paper-based system. “We were going to start transitioning to a new electronic system and had already moved to an electronic system to other areas of the institution, but the IRB was on the later end of that scale,” he explains.
The FDA’s focus appears to be more on COVID-19-related claims and bigger issues than conducting onsite visits. “They’re probably being pulled into other directions than IRB operating stuff,” he says. “Even accreditation bodies are recognizing that having someone onsite is not an option right now.”
Foreign preapproval and for-cause inspection assignments will continue to be postponed so long as they are not considered mission-critical, according to the FDA guidance.
Criteria for Inspections
The FDA assesses whether an inspection is mission-critical based on these factors:
- Have the products received breakthrough therapy designation or regenerative medicine advanced therapy designation?
- Are the products used to diagnose, treat, or prevent a serious disease or medical condition for which there is no other appropriate substitute?
“Both for-cause and preapproval inspections can be deemed mission-critical,” the FDA wrote. “The FDA takes into account concerns about the safety of its investigators, employees at a site or facility, and, where applicable, clinical trial participants and other patients at investigator sites.”
The FDA’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research will continue to evaluate applications, using a holistic approach to determine whether an inspection is warranted or no longer needed.
“The agency encourages applicants to be in communication with all their facilities and sites to ensure timely responses to any inquiries to support application assessment,” the guidance stated.