FDA is postponing all domestic routine facility inspections in response to the novel coronavirus outbreak, coming one week after the agency hit pause on most overseas visits, reducing its in-person oversight to for-cause, mission-critical assignments.
With the number of cases in the U.S. nearing 10,000 and expected to keep rising, FDA on Wednesday said the new policy is aimed at protecting its inspectors and address industry fears about receiving visitors.
- "Importantly, all domestic for-cause inspection assignments will be evaluated and will proceed if mission-critical," the agency said. "We will continue to respond to natural disasters, outbreaks and other public health emergencies involving FDA-regulated products."
FDA typically performs routine inspections of domestic manufacturers of medical devices and other products every few years, with the exact schedule being determined by a risk analysis. But in the current pandemic scenario, the agency has decided the benefits of these inspections no longer outweigh the risks, citing “the health and well-being of [its] staff” and “industry concerns about visitors” to explain the decision.
In absence of routine inspections, FDA Commissioner Stephen Hahn said the agency is looking into ways to conduct inspection work that do not put agency staff, the companies they visit and the public at risk.
“This can include, among other things, evaluating records in lieu of conducting an onsite inspection on an interim basis when travel is not permissible, when appropriate,” Hahn said in a statement.
Hahn downplayed the necessity of the inspections for the health of the system, framing them as part of a “multi-pronged approach to overseeing the safety and quality of FDA-regulated products” to provide reassurance about the likely impact of the change in policy. Last year, the domestic violation rate was around 5%, a figure Hahn used to back up his argument that companies "understand and appreciate their shared responsibility to ensure the integrity of the supply chain."
But going into 2020, FDA had anticipated stepping up its enforcement actions against medical device companies, citing the lessening of disruption related to its reorganization to argue that it was poised to start issuing more warning letters. The prediction followed a five-year period in which the number of FDA warning letters issued to medical device manufacturers fell by around 90%.
FDA’s ability to deliver the anticipated uptick in warning letters is now in question. The agency plans to “resume any postponed inspections as soon as feasible,” but the experiences of countries hit by the novel coronavirus before the U.S. suggests it may be some time before the situation is sufficiently under control for the inspection program to get back to normal.