FDA Admits Delays in Response , to Baby Formula Shortage.
The Food and Drug Administration (FDA) released a report detailing its response to the shortage on Sept. 22.
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 the public health, if you don’t have some understanding of how all the pieces fit together, , Robert Califf, FDA Commissioner, via NBC News.
... then when you get into a
crisis or a shortage you
have a real problem, Robert Califf, FDA Commissioner, via NBC News.
To a large extent that’s what happened here, Robert Califf, FDA Commissioner, via NBC News.
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, Scott Faber, Environmental Working Group,
via NBC News.
Nothing in this evaluation addresses the fragmented leadership structure that led to critical communication failures, Scott Faber, Environmental Working Group,
via NBC News.
U.S. 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."