The 10-page report cites several aspects of the agency’s response. including poor data-sharing systems, staffing shortages and lack of oversight for the specific manufacturing and supply chain protocols.
“For things that are critical to public health, if you don’t have some understanding of how all the pieces fit together. Then when you get into a crisis or a shortage you have a real problem. To a large extent, that’s what happened here,” Robert Califf, FDA Commissioner.
The report arrives several months after a baby formula manufacturing plant in Michigan was closed because of safety issues. An FDA investigation into a whistleblower’s warning about the plant didn’t begin until months after the complaint was filed.
Consumer advocates say the FDA’s report falls short of what is needed to fully address systemic issues. “This internal evaluation treats the symptoms of the disease rather than offering a cure. Nothing in this evaluation addresses the fragmented leadership structure that led to critical communication failures,” Scott Faber, Environmental Working Group.
Inventories of baby formula have increased from 69 percent in July to 80 percent. Imports of various baby formula products have increased significantly since May. The FDA’s food division is currently under an external review seeking answers to “questions about the structure, function, funding and leadership.”