See Me, Feel Me: FDA Gives Guidance on Remote Interactive Evaluations of Drug Facilities During COVID-19

Channeling The Who’s Tommy Soundtrack and the classic song “See Me, Feel Me,” the Food and Drug Administration issued a guidance document, “Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency.”¹  The facilities covered are those that manufacture pharmaceutical and biological products, those covered under the agency’s Bioresearch Monitoring Program, and outsourcing facilities registered under Section 503B of the Federal, Food, Drug and Cosmetic Act.

This Bulletin highlights some of the key points described in the guidance.

• A facility is not required to accept FDA’s request to conduct a remote facility evaluation. It may decline the request.  However, the agency notes that the decision may, as a result, delay its ability to evaluate the company’s facility or product, which can affect a timely regulatory decision on other matters, such as application review and approval.

• FDA will decide whether to conduct a remote interactive evaluation. It will not take requests from companies.  The agency will make its decision, in part, based on the company’s compliance history and product and facility risk.  Once FDA determines that a remote interactive evaluation is appropriate for a particular facility, the agency will notify the facility and applicant by email or phone call.

• Before conducting a remote interactive evaluation, FDA will schedule a virtual meeting to discuss logistics, responsibilities, and expectations. During that brief meeting, the agency may discuss several topics including, but not limited to, objectives and scope of the remote interactive evaluation, schedule of the virtual interactions and anticipated duration of the remote interactive evaluation, FDA’s expectations during the live streaming walkthrough of the facility, and technology limitations that could “impair or prevent”  FDA’s evaluation of the facility.

• During a remote evaluation, FDA expects companies to cooperate with the same level of transparency as they would during a live in-person FDA inspection. The agency may: request to review documents, use live stream and/or pre-recorded video to examine a facility, evaluate a facility’s corrective actions, and provide verbal updates to the facility on observations and outstanding issues.  FDA will not issue a Form FDA 482 (Notice of Inspection) to announce or open a remote interactive evaluation.

• FDA plans to request and review documents in advance of a remote interactive evaluation to ensure that the live stream interactions are as efficient as possible. However, additional documents may be requested during the actual evaluation.  The agency expects that all documents requested during the meeting will be provided in electronic format or will be accessible by screen-sharing during a live interaction.

• At the end of the inspection, FDA will have a closeout meeting with the facility’s management in order to discuss any observations. The agency will present a list of observations, but will not issue a Form FDA 483 (Inspectional Observations).  A remote interactive evaluation is not considered to be a final agency action.  However, similar to a live, in-person inspection, FDA expects facilities to respond to the observations during the discussion and/or to provide responses, in writing, to the observations within 15 U.S. business days.

• FDA will provide a copy of the final remote interactive evaluation report to the facility. This report and any written list of observations may be subject to disclosure under the Freedom of Information Act.

• If the agency decides that a live, in-person inspection will be necessary following the remote interactive evaluation, it will use the information obtained during the remote interactive evaluation to prepare and conduct the inspection.

AGG Observations

• Given that FDA’s decision to schedule a remote interactive evaluation depends, partly, on the facility/product risk and compliance history, it is unclear whether the agency will use this tool to evaluate a new or novel technology or manufacturing site.

• Because a remote interactive evaluation is not considered to be an official inspection, FDA notes that, after the issuance of a Warning Letter, the holding of a regulatory meeting, or following an enforcement action, the agency will continue its practice of conducting an in-person inspection to confirm that any corrective actions have been implemented.

• It is unclear how participating in a remote interactive evaluation will benefit a company if the company does not have the capability to fully participate (i.e., does not have the ability to have appropriate personnel participate virtually, provide required documentation, lack of IT capabilities) because FDA will expect the same level of compliance as a live, in-person inspection.

• While most companies have, as a result of the pandemic, updated their IT capabilities, it is very important that any IT issues are identified and addressed before any scheduled meeting with FDA to ensure a smooth process during the virtual walkthroughs.

[1] Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/remote-interactive-evaluations-drug-manufacturing-and-bioresearch-monitoring-facilities-during-covid