While pharmaceutical regulatory authorities in other countries are employing creative ways like video-based remote inspections to fulfill their obligations to the public, the U.S. Food and Drug Administration remains committed to conventional on-site inspections. By September 2020, the Covid-19 pandemic had precipitated a virtual pause in drug inspections: Roughly 85% of inspections had been curbed within U.S. borders and 99.5% outside the country.
Inspecting manufacturing facilities is a vital part of drug approval and production, and backlogs can cause huge delays, creating drug shortages in the global supply chain and threatening another global health crisis. Inspections are a key tool the FDA uses to ensure that drug producers adhere to manufacturing and record-keeping requirements, which ensures the safety of drugs on the market. Drug producers cannot legally operate without passing initial or recurring inspections.
Sticking with the traditional approach to inspections as a pandemic made them nearly impossible embodies a broader phenomenon across government: For years, U.S. agencies have been slow to adopt new remote and automated inspection technologies, many of which promise greater public health and safety at lower costs.