According to a press release issued by the FDA, the agency is postponing most foreign inspections through April, effective immediately, in response to the COVID-19 outbreak. Inspections outside the U.S. deemed mission-critical will still be considered on a case-by-case basis.
The FDA based this decision on a number of factors, including State Department Level 4 travel advisories in which travel is prohibited for U.S. government employees, Centers for Disease Control and Prevention 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 its employees, the agency reports.
The release states, “Another critical factor in taking this action is the confidence we have in our ability to maintain oversight over international manufacturers and imported products using alternative tools and methods. We are aware of how this action may impact other FDA responsibilities, including product application reviews. We will be vigilant and monitor the situation very closely and will try to mitigate potential impacts from this outbreak in lockstep with the whole of the federal government. We stand ready to resume foreign inspections as soon as feasible.”
The FDA says that when they are temporarily not able to physically inspect foreign produced FDA-regulated products or manufacturers, as an interim measure they employ additional tools to ensure the safety of products imported to the U.S., which have proved effective in the past. These include denying entry of unsafe products into the U.S., physical examinations and/or product sampling at U.S. borders, reviewing a firm’s previous compliance history, using information sharing from foreign governments as part of mutual recognition and confidentiality agreements and requesting records “in advance of or in lieu of” on-site drug inspections. For example, we began exercising this authority when we postponed on-the-ground inspections of manufacturers of FDA-regulated products in China earlier in the outbreak. This is all part of the FDA’s multi-pronged and risk-based approach to ensuring quality, as well as compliance, with applicable federal laws and regulations.
The FDA says it will continue working with U.S. Customs and Border Protection to target products intended for importation into the U.S. that violate applicable legal requirements for FDA-regulated products, which may come from a variety of sources, such as first-time importers unfamiliar with regulatory requirements or repeat offenders trying to skirt the law. The FDA has the ability through its risk-based import screening tool (PREDICT) to focus examinations and sample collections based on heightened concerns of specific products being entered into U.S. commerce. The PREDICT screening continues to adjust risk scores as necessary throughout the COVID-19 outbreak. “We are keeping a close eye out for indications of port shopping or cargo diversion and will continue our oversight of shipments through potentially higher-risk venues such as International Mail Facilities. We can refuse admission of products that fail sample testing or may violate other applicable legal requirements,” the release states.
The FDA says that Americans can rest assured the agency is diligently monitoring this outbreak and the impact to its operations. The leadership team meets daily to talk about the myriad of urgent issues as they actively facilitate efforts to diagnose, treat and prevent the disease; survey the medical product supply chain for potential shortages or disruptions and help to mitigate such impacts, as necessary; and leverage the full breadth of public health tools, including enforcement tools to stop fraudulent COVID-19 activity.
“As this remains a dynamic situation, we will continue to assess and calibrate our approach as needed to help advance federal response efforts in the fight against this outbreak,” the release states.