STAT+: FDA sets aggressive deadline for inspection overhaul
The FDA has a huge job ahead of overhauling the way it handles inspections of regulated products, and it plans to get it done this year.
WASHINGTON — Food and Drug Administration officials hope to finish this year a massive overhaul of the way the agency inspects facilities that make drugs, medical devices, and food products, they said Friday.
The reorganization was spurred by the FDA’s mishandling of the infant formula crisis. The agency was slow to inspect a major infant formula plant despite a whistleblower complaint about deadly bacterial contamination at the facility. An investigation found that the delayed response was due in part to the agency’s organization. A nonprofit, nonpartisan advisory body reported in December it was not clear who is in charge of food oversight, and agency food safety staff are siloed among divisions that don’t communicate with each other.
Although the food center has been the focus of attention in the reorganization, it will affect a huge swath of the agency. The reorganization is expected to impact about 8,000 FDA employees, according to Michael Rogers, FDA associate commissioner for regulatory affairs. The Office of Regulatory Affairs, which will be called the Office of Inspections and Investigations under the proposed reorganization, will go from having about 5,100 full-time employees to 3,586 employees.
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