Yesterday, the FDA issued a long-awaited guidance titled Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency (here).  The guidance notes that the Agency will determine whether remote inspections will occur and which tools are appropriate as alternatives to on-site inspections but indicates that it will not accept requests from sponsors to conduct alternate inspectional options.  The FDA will decide (based on program priorities) whether to ask sponsors if they are willing to participate in a remote inspection for a specific application or issue.

The guidance provides considerations for a number of different types of inspections but does not preclude their use for other inspectional categories.  The Agency lists the following type of inspections and specific considerations for each:

  • Pre-Approval and Pre-License Inspections may be used to assess applications for the purposes of approval, but not if there are data integrity issues or other issues.
  • Post-Approval Inspections are most likely to be used when firms have good inspectional histories, no data integrity issues, and the tools used will help the Agency assess the issues.
  • Surveillance Inspections will not replace on-site inspections, but information obtained will provide the basis for the scope and timing of future on-site inspections.
  • Follow-up and Compliance Inspections may be useful to ensure that, after a warning letter, corrective actions have been completed or to address specific quality issues. Such inspections will not be appropriate if there are data integrity issues.
  • Bioresearch Monitoring Inspections may be “used to assess the facility’s conduct, including data reliability and human subject protections to determine the acceptability of BIMO studies for FDA’s application decision-making.” Such inspections will not be appropriate if data integrity concerns exist or if there are other issues that the FDA determines warrant on-site inspection.  Again, the firm’s compliance history will be taken into consideration.

The Agency notes that “[F]ailure to cooperate with either an inspection or a 704(a)(4) request for records or other information may constitute a limiting of inspection and as a result, FDA may deem the relevant drugs manufactured at these establishments adulterated.  See the guidance for industry Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection (October 2014) for further information.”

As part of a remote inspection, the guidance indicates the Agency will:

  • Request and review documents, records, and other information (electronic systems).
  • Use livestream and/or pre-recorded video to examine facilities, operations, 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). An inspection instead of a remote interactive evaluation may be necessary to verify the adequacy of some corrective actions or if evaluating corrective actions remotely would unreasonably extend the duration of the remote interactive evaluation.
  • Provide verbal updates to the facility on observations and outstanding issues, whenever feasible.

The document also contains recommendations for preparation for a remote interactive evaluation, how the Agency will conduct the remote evaluation, and what it will expect to see.  Expectations for remote review of records are also addressed.

The Agency will only permit the use of its own technology platforms for security reasons and, thus, the site should participate utilizing FDA Microsoft Teams, FDA Zoom for Government, or FDA Adobe Connect.

The FDA intends to use information from remote interactive evaluations to meet user fee commitments and to update the FDA’s relevant internal databases.  The FDA expects that remote interactive evaluations will generally enable it to meet user fee goal dates.  However, the FDA will notify applicants if it expects to miss their user fee goal date.  The FDA indicates that it hopes to meet currently established response timeframes applicable to inspections.

So, bottom line – do not solicit a remote inspection/evaluation but be prepared if your number is called.  Read the guidance closely so you know what to expect and what the Agency’s expectations are.  Hopefully, this year will see a normalization of on-site inspections but, for now, remote evaluations will have to fill the gap.