FDA Postpones Inspections of Foreign Facilities Due to Coronavirus OutbreakBy
The US Food and Drug Administration (FDA) has announced this week (March 10, 2020) that it will postpone most inspections of foreign facilities, effective immediately, through April 2020 in response to the novel coronavirus (COVID-19) outbreak. Also, the European Medicines Agency (EMA) announced this week (March 11, 2020) that all meetings of EMA committees and working parties will be held virtually until the end of April 2020.
FDA’s inspection of foreign facilities
The FDA had issued its supply-chain surveillance plan last month (February 2020), in which it announced it was postponing inspections of facilities in China. Its most recent announcement now postpones most FDA inspections of facilities outside the US through April 2020. The FDA says that inspections outside the US deemed mission-critical will still be considered on a case-by-case basis.
The FDA said it based its decision on a number of factors, including US State Department Level 4 travel advisories in which travel is prohibited for US government employees, the US Centers for Disease Control and Prevention travel recommendations, access restrictions being imposed on foreign visitors by certain countries, guidance from the US Office of Personnel Management, and the health and safety of its own employees. The agency says it will 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,” said FDA Commissioner Stephen Hahn in the agency’s March 10, 2020 statement. “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.”
Hahn noted that when the FDA is temporarily not able to physically inspect foreign produced FDA-regulated products or manufacturers, as an interim measure, it employs additional tools to ensure the safety of products imported to the US, which have proved effective in the past. These include: denying entry of unsafe products into the US; physical examinations and/or product sampling at US 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, the FDA began exercising this authority when it postponed on-the-ground inspections of manufacturers of FDA-regulated products in China earlier in the outbreak.
The FDA says it will continue working with US Customs and Border Protection to target products intended for importation into the US 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. The FDA has the ability, through its risk-based import screening tool (PREDICT), to focus its examinations and sample collections based on heightened concerns of specific products being entered into US commerce. The agency says 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,” said the FDA in its statement. “We can refuse admission of products that fail sample testing or may violate other applicable legal requirements.”
EMA’s decision on virtual meetings
As a precautionary measure, the EMA announced on March 11, 2020 that all meetings of EMA committees and working parties will be held virtually until the end of April 2020. In addition, stakeholder events hosted by EMA that were planned to take place at the agency’s premises in Amsterdam in March and April (2020) will either be held virtually or postponed until later in the year. Participants of these meetings will be informed directly about this decision.
The EMA says that these measures aim to limit international travel and the number of visitors coming to EMA’s offices in order to reduce the risk of an infection with the novel coronavirus for delegates, visitors and staff.
The EMA has also initiated its Business Continuity Plan to provide a clear structure for the agency’s management of the COVID-19 outbreak. “The agency’s overarching goal is to ensure that the assessment and monitoring of medicines are not disrupted and that patients in Europe continue to have access to high quality, safe and effective treatments during the COVID-19 outbreak,” said the EMA in its March 11, 2020 statement.
The EMA says its core activities are not impacted by these measures and the agency will ensure that the virtual meetings will be conducted in the most efficient way. “Continued coordination with the EU regulatory network and other European institutions is essential to manage the COVID-19 crisis,” said the EMA in its statement. The EMA says that the European Commission’s Directorate-General for Health and Food Safety, the European Center for Disease Prevention and Control, and the EMA will have videoconferences three times per week to share information and expertise.
The EMA says its plans are being continually reviewed. The EMA’s dedicated webpage on COVID-19 is updated as the situation develops.