The ongoing spread of the novel coronavirus has prompted the Food and Drug Administration to postpone most foreign inspections of manufacturing facilities through April.
For the next several weeks, the agency will not conduct routine inspections, but may inspect facilities where manufacturing concerns may exist or perform what is known as a pre-approval inspection, which refers to a facility that is to be used to make a medicine. Such inspections will be considered on a case-by-case basis.
The decision comes as governments attempt to cope with the fast-spreading coronavirus, and is the latest sign of how the disease it causes is disrupting day-to-day routines and having an adverse impact on economies. By postponing inspections, for instance, the FDA will not be in a position to visit facilities that would be reviewed as part of product applications.
“We are aware of how this action may impact other FDA responsibilities, including product application reviews,” the agency said in a 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.”
The move also comes at a time when inspections of foreign manufacturing facilities were already a hot-button quality control issue. For more than a decade, the agency has been under pressure from Congress to exercise greater oversight of plants, which was triggered after adulterated heparin made in China led to dozens of deaths of U.S. patients in 2008.
Over the last few years, the FDA has responded by attempting to increase its inspection staffs in China and also India, where quality control problems have been a long-running concern. As a result, the agency has issued a growing number of warning letters to manufacturers in those countries. However, the advent of the coronavirus has also curtailed production there. And the FDA has reduced staffing in China to what a spokesman called “emergency levels,” although the number of personnel and how that compares to regular staffing was not disclosed.
For now, the FDA expects to use other means to ensure that unsafe products do not enter the U.S. These include denying entry into the U.S.; physical examinations and product sampling at U.S. borders; reviewing a company’s previous compliance history; and sharing information with foreign governments as part of mutual recognition and confidentiality agreements.
The agency also expects to request records instead of on-site drug inspections, a tactic that was begun earlier this year after on-the-ground inspections in China were postponed once the coronavirus took hold there. The FDA has “confidence … in our ability to maintain oversight over international manufacturers and imported products using alternative tools and methods,” the statement read.
“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 agency maintained.