A Less-Hazy Crystal Ball: Updates on FDA Inspections During the COVID-19 Era

By: Samantha Hong and Jacqueline J. Chan

Back in May, FDA issued its “Resiliency Roadmap for FDA Inspectional Oversight” report describing FDA’s oversight activities after the onset of the COVID-19 pandemic and plan for inspections moving forward. We previously wrote about the Resiliency Roadmap here.  At the time, FDA projected future inspection levels based on three different pandemic scenarios:  best-case, base-case, and worst-case.  Now, six months later, FDA has issued “An Update to the Resiliency Roadmap for FDA Inspectional Oversight” to discuss the agency’s implementation of the Resiliency Roadmap to date.

As we discuss further below, since this summer, FDA has proceeded with the Base-Case Scenario, involving a gradual transition back to standard operations, and has exceeded its anticipated inspection levels as compared to its initial May 2021 projections.  FDA relied heavily on alternative oversight tools to achieve these outcomes and we can expect that it will continue to do so for the foreseeable future as the pandemic progresses.

Relevant Background

FDA previously calculated that as of March 2021, there were over 15,000 domestic routine surveillance inspections remaining to be conducted in fiscal year 2021 that were postponed due to the pandemic.  FDA estimated that by the end of September it would be able to complete 27% of these inspections in a Best-Case Scenario (immediate resumption of standard operations) and 14% in a Base-Case Scenario (gradual resumption of standard operations).  In a Worst-Case Scenario (no resumption of standard operations due to increased COVID-19 risks), FDA expected to focus solely on mission critical inspections and rely on alternative oversight tools to minimize risk.

Insights from FDA’s Resiliency Roadmap Update

After transitioning to the Base-Case Scenario in July 2021 and gradually resuming standard operational levels, as of the end of September, FDA completed a total of 4,849 domestic surveillance inspections or 31% of the remaining inspections—more than doubling its projection of 14% completion under the Base-Case Scenario.  Of these inspections, 3,710 involved human and animal foods, including Foreign Supplier Verification Program inspections, and 1,139 involved human and animal medical products.

FDA emphasized its use of alternative oversight tools—such as records review, remote inspections, and leveraging information from foreign and state regulatory partners—to complete these inspections as well as to inform other oversight needs.  For instance, FDA relied on records review pursuant to the agency’s statutory authority[1] to support NDA and ANDA approvals as well as to support Emergency Use Authorization decisions.  FDA also appealed to state and local partners to conduct nearly 4,000 food facility domestic surveillance inspections on FDA’s behalf since April 2021.

As throughout the pandemic, FDA also continued other oversight activities, including:

  • “Mission-critical” work, including inspections related to the approval or availability of drugs for serious diseases for which there is no substitute, serious adverse events, or food outbreak responses.
  • For-cause follow-up inspections for prior domestic inspections classified as “official action indicated.” 
  • Inspections and facility assessments necessary to support decisions on medical product approvals or authorizations.[2] 

Moving Forward

In addition to continuing its risk-based approach for prioritizing oversight activities, FDA has made clear that it intends to increasingly rely on remote inspections and other alternative oversight tools where in-person inspections are not practical or feasible.  Indeed, FDA established the FDA Inspectional Affairs Council (FIAC) in July [3] to “develop a multi-year strategic action plan to enhance our coordinated approach to inspections, information sharing, and other processes to accelerate evaluation and potential integration of new oversight methods and tools.”  In the Resiliency Roadmap Update, FDA announced FIAC’s intent to focus on the use of Remote Regulatory Assessments among its top initial priorities.  Such assessments involve records requests made pursuant to FDA’s statutory authority as well as requests for voluntary submission of records and remote interactive evaluations—tools, as we mentioned, that FDA has already been employing over the course of the pandemic.

The Resiliency Roadmap Update reflects FDA’s commitment to achieving its inspectional goals despite the obstacles presented by COVID-19.  We can expect that with no clear end in sight to the pandemic, FDA will continue to adapt and utilize new strategies for accomplishing oversight activities that were previously conducted primarily through FDA in-person inspections.  We will continue to monitor FDA’s inspection and enforcement activities during these unprecedented times.

[1] 21 U.S.C. § 374(a)(4).

[2] Decisions on 60 applications, including 52 human drugs, 7 animal drugs, and 1 device, remain delayed pending inspection.

[3] See FDA News Release, “Coronavirus (COVID-19) Update:  FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future State of Operations” (May 5, 2021), available at https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-outlines-inspection-and-assessment-activities-during-pandemic.