By: Janet Woodcock, M.D., Acting Commissioner of Food and Drugs and Judy McMeekin, Pharm. D., Associate Commissioner for Regulatory Affairs
Over the past year, the U.S. Food and Drug Administration’s approach to foreign and domestic inspections for food and medical products has been both risk-based and deliberate. The COVID-19 pandemic required FDA to rework their business operations so that they could carry out its public health mission while protecting their workforce, and the workforces of those they regulate.
Food and medical product manufacturers of FDA-regulated products generally are required to have a quality management system, known as preventive controls systems for food safety plans in the food industry, in place to ensure that their products are suitable for the U.S. consumer. The FDA conducts inspections to verify that these quality management systems are in place and operating as required, and to note and mandate corrections when they are not functioning appropriately. While on-site inspections represent a key tool, they are one part among multiple components of a comprehensive approach to the oversight of FDA-regulated products.
During the pandemic, FDA has prioritized inspections by identifying those that are “mission-critical” on a case-by-case basis. This means that conducting the inspection was key to its public health mission and that the activity could not be accomplished in any other way. They have done this with careful consideration of many factors, including whether products:
Due to travel restrictions imposed in response to the global pandemic—implemented both at home and abroad—traveling to sites has been challenging, if not impossible in some situations. When FDA have been able to visit facilities in person, they have worked hard to protect the safety of their staff and others. In some cases, FDA investigators underwent required quarantine periods in various countries for 14 days prior to starting inspections, and again when they returned home.
In July of 2020, prioritized domestic surveillance inspections resumed using a rating system that the FDA developed to assist in determining when and where it is safest to conduct prioritized domestic inspections. The COVID-19 Advisory Rating system (COVID-19 Advisory Level) uses real-time data to qualitatively assess the number of COVID-19 cases in a local area based on state and national data. The resumption of prioritized domestic inspections is based upon location and COVID risk, not upon product type.
To extend their reach during the pandemic, the FDA created and implemented innovative approaches to facility oversight. When entering facilities for inspections was not feasible or advisable, they utilized the following:
They continue to assess the ongoing efforts we are taking to execute regulatory oversight. The examples below highlight some of the results:
As they look to the future, the FDA will continue to leverage and maximize every available tool and resource to meet its inspectional responsibilities while achieving optimal public health outcomes.
They will continue to study how to incorporate additional data sets and insights, and new technologies and tools for facility oversight, including the further use of remote interactive evaluations (e.g., remote livestreaming video of operations, teleconferences or screen sharing), and will work with industry to expand their use.
In concert with these efforts, they are pursuing agency-wide preparedness efforts for resuming a more normal state of operations, which will factor in how best to address inspectional activities that were paused due to the pandemic.
As they continue to navigate the challenges posed by this unprecedented public health emergency, they remain steadfast in advancing its mandate to protect and promote public health and ensure that the products they regulate are safe and of high quality for all Americans.