When the COVID-19 pandemic struck the U.S., manufacturers regulated by the Food and Drug Administration (FDA) were afforded some relief from agency inspections, allowing time to focus on adapting to a new norm. Roughly four months since a March 2020 notice announcing that FDA domestic facility routine inspections would be postponed, the agency is taking steps to restart on-site inspections the week of July 20, 2020.
The FDA has been modulating its inspectional conduct throughout the pandemic. Prior to scaling back domestic inspections in March, the agency had postponed foreign inspections on the basis of "State Department Level 4 travel advisories in which travel is prohibited for U.S. government employees, Centers for Disease Control and Prevention (CDC) travel recommendations, access restrictions being imposed on foreign visitors by certain countries, guidance from the Office of Personnel Management and the importance of the health and safety of [FDA] employees." The decision to delay domestic inspections followed a similar calculus, though the FDA underscored that it could still proceed with foreign and domestic mission-critical inspections, such as those conducted for-cause or in preparation for product approval.
Under a new agency inspectional risk assessment system to be analyzed at the county level, conducting only mission-critical inspections is the baseline category of regulatory activity. The remaining two categories are all inspections with caveats to help protect staff who have self-identified as being in a vulnerable population and resumption of all regulatory activities. The applicable regulatory activity category for a county is determined by the Phase of the State (as defined by The White House Guidelines for Opening Up America Again), statistics measured at the county level to gauge the current trend, and intensity of infection. Considering these three metrics, the FDA will utilize a new COVID-19 Advisory Rating system to render a COVID-19 Advisory Level that will help the agency decide when and where it's safest to conduct prioritized domestic inspections.
Although the agency intends to resume prioritized domestic inspections this month, the timeline will depend on the data about the virus' trajectory in a given state and locality and the rules and guidelines that are put in place by state and local governments. Before progressing to the next phase, FDA intends to look for downward trends in new cases of COVID-19 and hospitalizations in a given area. And as a practical matter, the ability to resume inspections is also affected by other services that have been curtailed by the pandemic, such as public transportation.
As drug and device manufacturers know, the FDA's policy has long been a risk-based approach to conducting inspections even before the COVID-19 pandemic. However, these prior risk assessments were largely focused on the product and manufacturer. The agency's new assessment system prompted by the pandemic is expected to be layered in with the former risk-based assessment framework, leaving many manufacturers confused about how to gauge the likelihood of an inspection at their facility. Until the agency provides further information, stakeholders are encouraged to monitor local COVID-19 statistics consistent with the FDA's metrics to help calibrate the likelihood of FDA inspectors showing up at the front door. Additionally, stakeholders should find some relief knowing that nearly all FDA prioritized domestic inspections will be pre-announced for the foreseeable future to help assure the safety of the investigator and the firm's employees. Given that the FDA has taken a stepwise approach to scaling back and ramping back up inspections, additional guidance is anticipated on FDA's on-site regulatory activities.
