The spread of the novel coronavirus has prompted the Food and Drug Administration to temporarily postpone all routine inspections of manufacturing facilities in the U.S. The agency has also directed most employees to begin teleworking.
The move, which comes one week after foreign inspections were suspended for several weeks, will halt inspections the agency typically conducts every few years based on risk analyses. Otherwise, the FDA will inspect facilities only when specific manufacturing issues arise and are evaluated as “mission critical.” This includes pre-approval inspections for products not yet approved for marketing.
Last year, the FDA conducted nearly 12,292 domestic inspections, down from 14,472 in 2018. These included inspections for a wide variety of products, including drugs, biologics, medical devices, food, and cosmetics and veterinary medicines. An agency database shows 3,101 foreign inspections conducted in 2019, down from 3,309 the year before. There was no breakdown for routine surveillance inspections.
In explaining its decision, the agency attempted to downplay concerns that oversight will be insufficient, an issue that has plagued FDA officials for several years. After scandals involving the heparin bloodthinner and a pharmaceutical compounder led to dozens of deaths, the agency has been under pressure to bolster inspections.
Despite the shift, though, the FDA maintained that it is reviewing additional ways to evaluate manufacturing plants and ensure public safety. “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,” FDA Commissioner Stephen Hahn said in a statement.
The agency noted that the inspections were halted to ensure the safety of its employees, but also in response to industry concerns about visitors. The FDA insisted it will continue to respond to natural disasters, outbreaks, and other public health emergencies involving products that the agency does not regulate, according to its statement.
As for teleworking, the FDA explained that the new mandate does not apply to personnel carrying out non-portable activities, such as certain lab activities or monitoring of imported products. There was no update concerning advisory committee meetings. Two meetings listed for April were postponed, but others scheduled for subsequent weeks remain on the agency calendar.