FDA Eyes End Of Year As Deadline For Inspection Procedure Overhaul
The reorganizational push at the agency comes in the wake of the infant formula crisis. Other FDA news is on manufacturing problems at an Eli Lilly plant, rules to trace foodborne illness outbreaks, and a Novartis breast cancer treatment TV ad.
Stat:
FDA Sets Aggressive Timeline For Overhauling Inspection Procedures
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. (Wilkerson, 1/22)
Reuters:
Exclusive: US FDA Finds New Manufacturing Lapses At Eli Lilly Plant
U.S. inspectors recently uncovered new manufacturing problems at an Eli Lilly plant that has been under scrutiny by federal investigators, according to government records obtained by Reuters. The U.S. Food and Drug Administration inspection in July at Lilly's Branchburg, New Jersey, plant detected eight separate deficiencies. They included problems in tracking manufacturing process and quality controls, as well as lapses in its calibration of equipment and failure to properly maintain facilities and equipment, the inspection report shows. (Taylor and Fick, 1/19)
CIDRAP:
Oversight Report Urges FDA To Finalize Food Traceability Rule
A new report from the Government Accountability Office (GAO) urges the US Food and Drug Administration (FDA) to finalize its plan to implement new rules to help identify sources of foodborne illness outbreaks. The FDA's final rule on food traceability, introduced in November 2022, established a list of certain foods for which enhanced recordkeeping is required, including additional traceability records to track certain points in the item's supply chain—known as critical tracking events. Products that contain dairy, eggs, nuts, prepared food, produce, and seafood are covered by the rule's recordkeeping requirements if that ingredient remains in the form in which it appears on the list, according to the FDA. Examples include fresh lettuce used in a bagged salad mix and a sandwich containing a tomato. (Dall, 1/19)
Stat:
FDA Scolds Novartis Over A Misleading TV Ad For A Breast Cancer Treatment
The U.S. Food and Drug Administration scolded Novartis for making false and misleading statements about a best-selling breast cancer treatment in a television ad in 2022. In a Nov. 18 letter, the agency admonished the company for touting the benefits of its Kisqali medicine by referencing data that did not support the messages in the ad. (Silverman, 1/19)
