USFDA's COVID-19 Supply Chain Update: Is There a Shortage?
The USFDA has been monitoring the nation's supply chain very closely with the expectation that the coronavirus outbreak would likely cause potential disruptions to supply or shortages of critical medical products in the nation.
The FDA has been contacting over 180 human drug manufacturers to notify them of any anticipated supply disruptions and to evaluate their entire supply chain. Some manufacturers have alerted the FDA about the shortage of a particular drug.
“A manufacturer just notified us that this shortage is related to a site affected by a coronavirus. The shortage is due to an issue with the manufacturing of an active pharmaceutical ingredient used in the drug,” FDA’s recent press release read. “It is important to note that there are other alternatives that can be used by patients. We are working with the manufacturer as well as other manufacturers to mitigate the shortage. We will do everything possible to mitigate the shortage.”
Here’s a gist of the supply chain update:
1. Human drugs
About 20 drugs solely source their active pharmaceutical ingredients from China. The FDA has been in touch with all those manufacturers to assess whether they face any drug shortage risks due to the COVID-19 outbreak. None of them have reported any shortage so far.
2. Medical Devices
A total of 63 manufacturers representing 72 different facilities in China that produce essential medical devices have also reported no shortages within the U.S. market. However, there are some supply challenges of personal protective equipment including gloves, gowns, masks, respirator protective devices and other products that are designed to protect the wearer from injury or the spread of infection or illnesses.
3. Biologics & Blood Supply
Currently, there are no reported shortages of biologics. But the FDA has no information pertaining to any cellular or gene therapies that are made in China for the U.S.
4. Food
The FDA isn’t aware of any reports suggesting COVID_19 transmission via food or food packaging. With more cases of COVID-19 appearing tin the nation, supermarkets and other retailers are preparing for a surge in demand for supplies including staple foods and cleaning products.
5. Animal Drugs
Among 31 animal drug manufacturers that source ingredients from china, six of them have notified that they could soon face shortages.
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