FDA Official Gives Update on Inspections During COVID-19 Pandemic

The FDA’s Office of Regulatory Affairs (ORA) has determined that general and prioritized inspections will remain preannounced for the foreseeable future in order to ensure the safety of those involved during the pandemic, according to a regulatory official.

Elizabeth Miller, FDA assistant commissioner for medical products and tobacco operations, said that the agency has conducted more than 200 mission-critical inspections since it began doing them in March 2020 and continues to conduct high-priority inspections, including inspections of facilities that make products in shortage, inspections for novel or COVID-19 drug approvals and bioresearch monitoring inspections.

The FDA is continuing to adapt during the pandemic and is making more use of remote measures in place of on-site inspections to ensure firms continue to meet regulatory requirements during the crisis, Miller said.

In addition, ORA is conducting on-site investigations of manufacturers in the early stages of producing COVID-19 countermeasures, such as vaccines. She noted that the ORA is conducting an analysis of its inspection process designed to find new ways to optimize inspection-related activities.

For example, the FDA is exploring how to best use new technologies and tools to support its inspections during the pandemic, including a pilot program that is assessing the use of live and recorded video, Miller said Tuesday during the 15th Annual FDA Inspection Summit hosted by FDAnews.

The agency is also using remote regulatory assessments to help prioritize facilities for on-site inspections or postpone inspections for later, she said. The assessments involve the remote review of the records firms must keep to show compliance with FDA regulatory requirements.

“In general, the information is typically used as an indicator of a firm’s compliance and may allow us to focus and limit time needed on an on-site inspection or in advance of an inspection to later occur,” Miller said. “The agency will “continue to refine this new operation” and work toward expanding remote assessments, she said.

The FDA has been requesting records in advance or in lieu of inspections during the crisis with great success, she said. So far, industry has been very responsive to those requests and has generally met the agency’s timeframes. The ORA’s biologics team has issued 253 records requests to foreign and domestic biological drug establishments to prioritize on-site investigations. The agency has granted deadline extensions in certain cases when the requests were deemed reasonable, she said.

Miller acknowledged industry comments that there is no formal process to provide documentation indicating that records requests were completed and said the agency is now emailing a specific form (Form 4003a) to alleviate the problem. The forms serve as confirmation that records were received, give a complete list of all records requested and include language stating the agency reviewed the records.

The pandemic has made it difficult to physically inspect most foreign-made regulatory products, Miller noted, and the agency has taken several different approaches in response. These include enhanced import screenings, the issuance of import alerts for uninspected firms, product sampling and testing at U.S. borders, checking compliance history and using information from foreign governments.

The agency also continues to leverage its mutual recognition agreements (MRAs) with other regulators, such as through the use of foreign inspector reports, to adapt to the travel restrictions imposed by the pandemic. “FDA has been active in requesting reports from other regulators in advance of planned inspections to focus, adjust or shorten inspections,” she said.

Miller said she expects the lessons and best practices gathered from remote inspections during the pandemic to be incorporated into the FDA’s future standard operating model.

“I think one of the things you always hear is you never let a good crisis go to waste. I think this opportunity is really helping us think about how we use our finite resources to the best public impact … and to really think through how we get the best public health outcomes,” she said. “We are taking stock of our experience [and] we are utilizing mid-action review of how we’ve experienced and pivoted during the COVID-19 response to really inform how we move ahead once we get to the other end of this pandemic.”

Miller said the agency will share its thoughts next month with the Pharmaceutical Inspection Co-Operation Scheme (PIC/S) on best practices and lessons learned from the pandemic so far. PIC/S is a collaboration between 53 international regulators to harmonize inspection procedures. The yearly inspection training session will consider remote assessments for good manufacturing practice (GMP) compliance. — James Miessler