Source : 'The Pink Sheet'
The US Food & Drug Administration has conducted “more than 200 mission critical” inspections since the COVID-19 disruptions began in March, Associate Commissioner for Regulatory Affairs Judy McMeekin said during the Food & Drug Law Institute’s recent annual meeting.
Those inspections cover the entire scope of FDA’s responsibilities, including both foreign and domestic activities. Examples of the types of inspections done include “inspections of facilities for which there may be a drug shortage, or inspections needed for approval of a novel drug or drugs related to the potential treatment of COVID-19,” McMeekin said.
The quantification of the number of mission critical inspections was one of the few new details from the ORA update at FDLI. In general, the agency is still not offering much information about the resumption of “routine” pre-approval inspection activity – and appears to be only in the very early stages of testing alternative models beyond the flexibility it has been applying throughout the pandemic.
Sponsors eager for more granular information on the current state of FDA’s domestic inspection activity – which resumed on a limited basis in July – would not have heard anything beyond FDA’s most recent update published in Q&A form in August. ()
FDA is conducting “routine” inspections on a pre-announced basis using its own “COVID-19 rating system” to determine which facilities are currently safe to visit. McMeekin offered little by way of specifics beyond that – in part because of the still widespread prevalence of COVID in the US. “The safety of our staff and the staff of the facilities that we regulate continues to be on the forefront of our minds,” she said.
ORA continues to work to assure that the disruption to the inspection process has as little impact as possible on FDA’s ability to complete new drug reviews on time.
McMeekin was asked whether industry should be prepared for an increase in missed user fee deadlines and/or complete response letters because of the inability to complete pre-approval inspections. Her answer was mostly reassuring: “We have been working extremely hard with our colleagues in CDER. We have weekly meetings to keep abreast of what the user fee goal dates are and do our best to make sure we achieve those.”
For now, however, FDA’s primary tool is to rely on its authority under Sec. 704(a)(4) of the FD&C Act to request records in lieu of an inspection, she emphasized. That may be less reassuring for sponsors with pending applications for complex products that likely require an in-person visit prior to approval. ()
FDA is exploring “virtual” inspections, but does not appear especially close to considering that approach in the context of a pre-approval inspection for a new drug or biologic.
“We are studying how we might incorporate new technologies and tools to support our inspection, including exploring a pilot to assess use of live or recorded video,” McMeekin said.
“Recently, we were able to test the use of live video on two produce farm inspection to facilitate live technical assistance form our headquarters to help with the sample targeting. As we learn more from the pilot as to how and when we might use these and other technologies, we commit to having transparent dialogue with regulated industry as to how this may affect our procedures in the future.”
She elaborated on the prospects for that approach in a pre-approval inspection in response to a question. “We have utilized mostly the 704(a)(4) authority for the preapproval inspections. As far as using virtual inspections on the drug side, that is something that we are looking at and assessing and would like feedback from our industry partners to see how that can increase efficiency.”
By Michael McCaughan