FDA outlines plan for making inspections more consistent going forward

The US Food and Drug Administration (FDA) has issued a new report outlining its inspectional activities during the COVID-19 pandemic, caused by the spread of the SARS-CoV-2 coronavirus, and its detailed plan to move toward a more consistent state of operations going forward.

“Like most organisations around the world, the FDA experienced unprecedented and unique challenges during the SARS-CoV-2 pandemic. In particular, our inspection, surveillance and compliance activities were significantly impacted,” explained Acting FDA Commissioner, Dr Janet Woodcock. “The FDA fully understands the importance of getting back to a more consistent state of inspectional capacity. This plan provides the public with a transparent picture of both the successes and challenges we have faced in these areas over the past year, as well as our plan moving forward. We want to assure the American public that we have used a variety of tools to oversee the regulated industry and ensure that Americans continue to have access to safe food and high-quality FDA-regulated products.”

COVID-19 impact

The FDA announced in March 2020 that it was temporarily postponing all domestic and foreign routine surveillance facility inspections while attempting to continue mission critical inspections when possible, because of the pandemic. In mid-July 2020 the agency began to work toward resuming prioritised domestic inspections using its COVID-19 Advisory Rating system. Mission-critical inspections include inspections of facilities for which there was a drug shortage, inspections needed for the approval of novel drugs or drugs related to the potential treatment of COVID-19, support of pre-market and pre-license applications and response to foodborne disease outbreaks or other food safety risks.

Overall, the agency’s Resiliency Roadmap for FDA Inspectional Oversight report shows that between March 2020 and March 2021 the agency conducted a total of 821 mission-critical inspections, including 29 in foreign countries. Of these, 475 were in human medicinal product or bioresearch applications. The FDA also conducted 777 prioritised domestic inspections, 260 for human medicinal products, since it resumed that practice in July 2020. The report also indicates that only 68 of the roughly 13,500 applications for medical product approval or authorisation received since March 2020 have been delayed due to the inability to conduct inspections, with the FDA deeming the majority of those ‘not mission critical’. The report also shows how many inspections the agency was unable complete.

Within the report are details of the various alternative tools and approaches the FDA used where inspections were/are not currently feasible, including remote interactive evaluations (eg, remote livestreaming video of operations and teleconferences), record requests and leveraging information from trusted regulatory partners.

Moving forwards

The document also outlined the ongoing steps the agency is taking in order to resume standard operational levels of inspection activities, including how it intends to prioritise domestic and foreign inspections that were not performed during the pandemic. The plan incudes a variety of possible scenarios because the FDA said the trajectory of the ongoing pandemic is uncertain.

Under the plan, inspections considered critical to the FDA’s mission will remain the primary focus. When planning routine surveillance inspections, the agency will prioritise higher-risk establishments. Therefore, a longer interval between inspections will occur for the less high-risk facilities as the FDA adjusts to the impact of the COVID-19 pandemic. This means that postponed inspections will be prioritised based on risk and conducted over a longer period of time, ultimately increasing the amount of time between inspections of certain lower-risk facilities. The agency has so far planned 26,250 surveillance inspections for 2021, 2,953 have already been completed, and of the remaining 23,297, 3,829 are in human medicinal or bioresearch facilities.

The agency will also begin a multi-year modernisation effort to further transform their data enterprise platforms and cross-program interoperability infrastructure to better support innovation related to its regulatory oversight role, including remote approaches. According to the agency, this effort will include a review of inspectional approaches using next-generation assessment technologies and improvements. The FDA is also establishing an agency-wide FDA Inspectional Affairs Council that will plan and co-ordinate inspectional activities.