On April 14, 2021, the Food and Drug Administration (“FDA”) released a guidance document concerning the framework under which it plans to conduct voluntary remote interactive evaluations of selected drug manufacturing and bioresearch monitoring facilities during the COVID-19 pandemic.
FDA has faced significant challenges conducting facility inspections during the pandemic in a manner that does not put its employees and those of inspected facilities at risk. During the pandemic, FDA has been using tools other than inspections to support regulatory decisions and oversight of facilities. The framework for remote interactive evaluations described in FDA’s guidance, titled “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency,” will provide FDA with an additional tool for evaluating a facility’s compliance with regulatory requirements without requiring a traditional, in-person inspection.
In releasing the guidance, FDA is signaling its intent to substantially expand its program of remote evaluations to help eliminate the current backlog of inspections. Expanded use of remote evaluations will enhance FDA’s ability to conduct timely reviews of drug approval and license applications and catch up on surveillance inspections that have been delayed since the beginning of the pandemic. While FDA is clear that it will not be performing “remote inspections” with the new guidance, the practical difference between remote inspections and remote interactive evaluations appear to be minimal.
The guidance outlines considerations for planning a remote interactive evaluation (see section I below), conducting the remote interactive evaluation once it is planned and agreed to by the facility (see section II below), concluding the evaluation (see section III below), and the regulatory impact of findings made during the evaluation (see section IV below).
I. Planning a Remote Interactive Evaluation
FDA may request a remote interactive evaluation whenever a program office determines it is appropriate based on mission needs and any travel limitations. The drug inspection programs eligible for remote interactive evaluations include Pre-Approval Inspections and Pre-License Inspections, Post-Approval Inspections, Surveillance Inspections, Follow-up and Compliance Inspections, and Bioresearch Monitoring Inspections.
Based on its risk management methods and tools, FDA will decide when to request that a facility participate in a remote interactive evaluation. FDA wil not accept requests from applicants or facilities for FDA to perform such an evaluation. Facilities and applicants identified as appropriate for a remote interactive evaluation will be notified by FDA. FDA will then contact the facility to confirm the facility’s point of contact and to discuss other logistical points for the evaluation, including the facility’s technological capabilities related to the performance of any interviews, and the provision of any requested documents, remotely. Facilities may decline FDA’s request to perform a remote interactive evaluation, but FDA notes that doing so could impede the agency’s ability to make timely regulatory decisions.
Once a facility confirms its willingness and ability to participate in a remote interactive evaluation, FDA will schedule a virtual meeting to discuss logistics, responsibilities, and expectations. Potential discussion topics are listed in the guidance.
II. Conducting a Remote Interactive Evaluation
FDA expects the same level of participation and transparency during remote evaluation as it does during traditional inspections. Notably, FDA will not issue a Form FDA 482 prior to the start of the remote interactive evaluation, as FDA does not consider these evaluations to constitute inspections under the Federal Food, Drug, and Cosmetic Act.
As part of a remote interactive evaluation, FDA may:
- Request and review documents, records, and other information (electronic systems).
- Use livestream and/or pre-recorded video to examine facilities, operations, and data and other information.
- Through the facility’s point of contact, schedule interviews and meetings to address any questions or concerns.
- Evaluate a facility’s corrective actions (e.g., in response to a previous inspection or evaluation, or to the current remote interactive evaluation). FDA may require that some corrective actions be assessed through a traditional inspection.
- Provide verbal updates to the facility on observations and outstanding issues, whenever feasible.
FDA’s guidance explains the technological requirements for participating in a remote interactive evaluation. Technologies should be sufficient for FDA to review the requested information and, to the extent practicable, remotely view and evaluate operations at the facility.
Although FDA will typically request at least some documents prior to conducting the remote interactive evaluation, FDA may request additional documents and other information during the course of the evaluation. Documents must be provided in an electronic format. If a facility maintains certain records in paper format only, the facility should be prepared to scan the documents as searchable PDFs.
III. Concluding a Remote Interactive Evaluation
FDA will hold a closeout meeting at the end of the evaluation, similar to its practice with respect to traditional inspections, in which FDA will present a written list of observations and allow the facility the opportunity to respond verbally. Information collected during these evaluations may be used to gather information about a pending regulatory filing, among other regulatory purposes. FDA will not, however, issue a Form FDA 483 following the conclusion of the evaluation. Instead, FDA will provide a copy of the final remote interactive evaluation report to the facility.
IV. Impacts of Remote Interactive Evaluations on FDA Commitments and Timeframes
FDA intends to utilize this process to meet user fee commitments by gathering necessary pre-approval information through remote interactive evaluations. Relatedly, FDA intends to adhere to the existing 15-day timeframe for submitting responses and corrective actions following an inspection for the responses to be eligible for consideration during the evaluation of a pending application.
FDA does not indicate whether it will make facility compliance classifications (i.e., OAI, VAI, or NAI) based on the results of a remote interactive evaluation, but it does make clear that they may be used to “[s]upport a regulatory meeting, warning letter, import alert, recall activities, or
enforcement action.” Once a firm accedes to a remote interactive evaluation, it appears that FDA will be free to use collected information as it would following a traditional inspection. While this will benefit most firms by facilitating application and license approvals, other firms could be subject to enforcement actions based on the results of a remote interactive evaluation.
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This guidance is effective immediately, but comments may still be submitted to the Agency for consideration. Except as otherwise noted in the guidance, this version of the guidance will remain in effect for the duration of the public health emergency declared by the Secretary of Health and Human Services, FDA may incorporate changes in the guidance, based on public comments received in response to this guidance.
If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Drug, and Device Practice.
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