Resumption of FDA Inspections: What’s Next?

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Resumption of FDA Inspections: What’s Next?

By Alessandra Baffa, Consultant & Liz Bodi, Asoociate Principal Consultant

Over the last few months, our clinical research industry has been compelled to pivot on a number of fronts due to the spread of COVID-19. As we start to open up, biopharmaceutical operations in the United States are challenged to maneuver new paradigms including how FDA inspections will be conducted. On July 10, 2020, the FDA announced the resumption of domestic inspections with a newly developed risk-based approach. While all on-site inspection activities were halted until now, the FDA noted its success in employing a number of tools, including remote assessments, to ensure the quality and safety of FDA-regulated products were maintained.

In a press release, the FDA highlighted its COVID-19 Advisory Rating system (“COVID-19 Advisory Level”) which utilizes “real-time data to qualitatively assess the number of cases in a local area based on state and national data.” The FDA will determine the Advisory Level based on 1) what phase a given state is in; 2) the county-level statistics/trends and 3) the intensity of infection. The Advisory Level provides the degree of regulatory activity that may be permitted in a particular geographic area. Though, there are a handful of unanswered questions, such as: What types of sites will be inspected? Will hospitals and academic research centers be included? Will this qualitative assessment disqualify entire states or will clinical investigators be assessed individually?

Yet despite remaining questions, the guidance does highlight three key elements for clinical investigators and sponsors to consider including, 1) the prioritization of safety; 2) the essential use of technological solutions to ensure operational continuity, and 3) the lasting need for inspections to occur due to evolving risks of the industry. Technological solutions, including remote monitoring, telemedicine visits and other virtual trial activities, are becoming more of a necessity than an option. As the agency turns towards an increasingly virtual approach, there is a responsibility and unspoken commitment of those in the industry to stay ahead of the curve by implementating the required electronic systems and solutions.

Thankfully, in order to ensure the safety of FDA investigators and inspection participants, the FDA noted in its release that all prioritized domestic inpections will be pre-announced. This is a singular opportunity and a clear call to sponsor and clinical investigator preparedness across the board, if there ever were one. With patient safety and data integrity as the focus, inspection preparation activities should and can begin now, regardless of an anticipated inspection date – it’s in your best interest to always be prepared. That being said, the implementation of optimized technological solutions, reviewing and documenting actions taken as a result of COVID-19 regulatory guidance(s) and initiation of risk-based quality assessments should continue to verify data integrity and remain at the forefront in the months to come.