FDA to restart domestic inspection program using new Advisory Rating system

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The U.S. Food and Drug Administration (FDA) said Friday it plans to resume on-site inspections of FDA-regulated facilities and other associated activities the week of July 20, 2020. The agency had temporarily halted most domestic facility inspections on March 18, 2020, as part of the government’s response to the COVID-19 pandemic. FDA has been conducting limited mission critical inspections over this period. FDA plans to use its new COVID-19 Advisory Rating system to determine where it will be safe to conduct pre-announced domestic inspections moving forward.

FDA Commissioner Stephen Hahn said in a statement that FDA is “working toward the goal of restarting on-site inspections during the week of July 20,” but “resuming prioritized domestic inspections 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.” To determine where it is safest to conduct domestic inspections, Hahn described how FDA will rely on the agency’s new COVID-19 Advisory Rating system (“COVID-19 Advisory Level”), which uses real-time data to qualitatively assess the number of COVID-19 cases in a local area, based on state and national data. Advisory Level data will also be available to FDA’s state partners, Hahn said.

The Advisory Level will be based upon the outcome of three metrics: Phase of the State (as defined by White House guidelines), and the current trend and intensity of infection, as based on county-level data. Considering each factor, FDA will identify which of three types of regulatory activities can occur within the given geographic region:

  • mission critical inspections only,

  • all inspections with caveats to help protect staff who have self-identified as being in a vulnerable population, or

  • resumption of all regulatory activities.

FDA noted that the availability of other services that have been curtailed by the pandemic, such as public transportation, will also be “an important factor” in how the agency determines resuming domestic inspections.

A critical aspect of FDA’s plan to restart domestic inspections is that they will be pre-announced for the foreseeable future. This is a meaningful difference from the traditional unannounced, surprise inspections that the pharmaceutical, biotechnology, and medical device industries are used to seeing.

As the coronavirus pandemic response evolves, we will continue to monitor FDA’s foreign and domestic drug inspection programs, related pharmaceutical supply chain issues, and the agency’s response to the COVID-19 outbreak more broadly. Please contact us if you have any questions.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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