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YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS

Over the past year and as a result of the COVID-19 pandemic, FDA relied on alternative inspectional tools and approaches, including remote interactive evaluations and record requests, as well as a prioritization scheme, to continue its oversight activities.

According to a recently released FDA report, while FDA conducted 218 mission critical and prioritized inspections of human drug and biologic facilities, the agency also made broad use of alternative inspection strategies. By example, FDA issued over 1,300 record requests to human and animal drug and biologic manufacturers. However, even with utilization of alternative mechanisms, the pandemic did take a toll on product approvals. FDA reports that there are 49 human drug and biologic applications for which approval is delayed due to pending inspections. There are also 87 remaining drug and biologic facility follow-up inspections that are needed to resolve prior “official action indicated” findings. This is not to mention numerous surveillance inspections that did not take place.

Given this backlog, one trend that industry will likely continue to see is FDA reliance on remote evaluations, as discussed in the agency’s April 14, 2021 final guidance regarding its approach to remote interactive evaluations of drug and biomedical facilities. This remote evaluation process applies to all drug inspection programs including pre-approval and pre-license inspections to assess a marketing application, post-approval inspections, ongoing surveillance, follow-up and compliance inspections, and bioresearch monitoring. FDA plans to use its information technology platforms and equipment, including teleconferencing, live-streaming video, and screen-sharing technologies to host virtual interactions and conduct remote evaluations, if deemed appropriate for a facility. Remote evaluations are in addition to FDA’s other inspectional strategies and may be combined with other tools, such as on-site inspections and record requests.

FDA will apply risk management methods and tools to determine when to request a facility’s participation in a remote interactive evaluation. The agency will not accept requests from firms, applicants, or facilities to conduct a remote evaluation. When facilities agree to participate in a remote evaluation, FDA expects the same type of cooperation and transparency as during site inspections. The guidance warns that if facilities do not agree to remote interactive evaluations, FDA may not be able to make timely regulatory decisions. It is not clear, however, whether a facility’s refusal of a remote evaluation when there are no pending applications or supplements or prior regulatory actions that need to be closed out, would have regulatory consequence. FDA insinuates, however, that such a refusal could be considered an action limiting an inspection, providing FDA authority to deem the drugs manufactured at the establishment to be adulterated.

Given the continued and potentially increasing reliance on remote inspections, facilities should be prepared to consider the strategic aspects of remote interactive evaluations. It is also strongly recommended that firms assess their inspectional procedures and adapt them to remote inspections. By example, firms should consider inspectional technology tools, timing, environments, the recording of the inspection, and the choice of personnel to host the remote inspection. Firms should also consider potential state and federal laws concerning intercepting or recording communications, as well as any employee and/or union consent or notification requirements. Further, firms should be prepared to respond to FDA inspector requests for broader and more extensive records during a remote inspection, as compared to what would normally be expected for in-person inspections.

Finally, firms should also consider how findings will be documented and responded to because FDA states that it will not issue Form 483 inspectional findings. Rather, the agency will provide a written list of observations and will discuss observations with facility management. This written list of observations, however, will not be considered to be final agency action. While it is currently unclear whether this list will be comprehensive or subject to change, whether this list will have legal significance, and whether FDA will issue Establishment Inspection Reports after a remote inspection, inspectional responses will still be necessary (FDA encourages facilities to respond during the discussion or via written response within 15 business days). Depending on the outcome of the remote inspection and responses, FDA will consider whether additional inspection or regulatory action is appropriate.

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