BIMO Inspectors Learn to Rely on Remote Assessments
During the Covid-10 pandemic, more than 70 bioresearch monitoring remote regulatory assessments have been conducted in lieu of physical FDA inspections to verify the clinical data that support regulatory applications, according to CDER Office of Compliance director Don Ashley. Speaking at a Pharmaceutical Quality Symposium 10/26, Ashley reflected on the early days of the pandemic and how CDER Compliance “adapted through sheer adrenaline, a lot of coffee and longer hours. But after a few months, we began to do a better job of developing new procedures to handle the increased and varied workload. For example, we developed a streamlined and very disciplined process for handling the increased number of regulatory discretion requests that CDER was receiving, and new procedures such as this were adopted across CDER, which I think has helped to tame the increased workload a bit as time has gone by.”
Ashley told the symposium that collaborations with global regulators have also been paying off in the bioresearch monitoring space. “Leveraging those relationships has been absolutely critical to our success during the pandemic,” he said citing the agency’s first-ever exclusive reliance upon a foreign regulatory partner’s (European Medicines Agency) inspection information to support the assessment of clinical trial conduct and data reliability for one of the new drug applications approved this year. “And, we really hope to be able to use our experience during the pandemic as a springboard into more and deeper collaborative activities going forward,” he added.
CDER Office of Pharmaceutical Quality director Michael Kopcha also shared his office’s experiences in collaborating with global regulators. “FDA is continuing with its routine review of mutual recognition agreement (MRA) reports for inspections in capable countries,” he said. “So this has helped us quite a bit in terms of the work that we need to do. We’ve also been able to request inspection reports for sites that are in countries actually outside of the EU from MRA-capable authorities, as well as other inspectorates that are members of what’s referred to as the Pharmaceutical Inspection Cooperation Scheme (PICS). So that’s been extremely helpful. We’ve also reviewed EU member state inspectorates to evaluate their capability to perform inspections in third countries. So we have found many are capable and we now rely on those third country inspections to also inform our review of applications.”
Office of Medical Products and Tobacco Operations assistant commissioner Elizabeth Miller told the symposium that while FDA has paused more of the surveillance and now focuses on mission critical inspections, the investigative staff have pivoted to doing record requests and reviews. She said a lot has been learned under that process and industry has stepped up its attention to providing those records and subsequent follow up and necessary context when requested.
Miller said ongoing collaborations with PICS partners has led to an understanding that the records evaluations take longer than if regulators were actually on site and then asking for records. “So we’re really looking to understand the sweet spot of how we use these in advance of inspections to make sure that our inspections can be focused and more impactful, and really enhance our public health mission in a way that we can get the most out of our resources,” she said.