COVID-19: USFDA updates about supply chain effect on medicines, devices and PPE

FDA has been closely monitoring the supply chain with the expectation that the COVID-19 outbreak would likely impact the medical product supply chain, including potential disruptions to supply or shortages of critical medical products in the U.S.

A manufacturer has alerted that a shortage of a human drug that was recently added to the drug shortages list. The 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.

" 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," the USFDA stated in its release

FDA further informed that since January 24, it has been in touch with more than 180 manufacturers of human drugs, not only to remind them of applicable legal requirements for notifying the FDA of any anticipated supply disruptions but also asking them to evaluate their entire supply chain, including active pharmaceutical ingredients (the main ingredient in the drug and part that produces the intended effects, e.g., acetaminophen) and other components manufactured in China.

 "As part of our efforts, the FDA has identified about 20 other drugs, which solely source their active pharmaceutical ingredients or finished drug products from China. We have been in contact with those firms to assess whether they face any drug shortage risks due to the outbreak. None of these firms has reported any shortage to date. Also, these drugs are considered non-critical drugs," the regulator stated

FDA: "We will remain in contact with manufacturers so that we can continue to assist them with any potential issues in the fastest way"

On the issue of medical devices, it stated that it aware of 63 manufacturers which represent 72 facilities in China that produce essential medical devices; FDA has contacted all of them. Essential devices are those that may be prone to a potential shortage if there is a supply disruption.

"FDA is aware that several of these facilities in China are adversely affected by COVID-19, citing workforce challenges, including the necessary quarantine of workers. While the FDA continues to assess whether manufacturing disruptions will affect overall market availability of these products, there are currently no reported shortages for these types of medical devices within the U.S. market." the FDA stated

Regarding personal protective equipment—surgical gowns, gloves, masks, respirator protective devices, or other medical equipment designed to protect the wearer from injury or the spread of infection or illness, the FDA stated that is currently not aware of specific widespread shortages of medical devices, but we are aware of reports from CDC and other U.S. partners of the increased ordering of a range of human medical products through distributors as some healthcare facilities in the U.S. are preparing for potential needs if the outbreak becomes severe.

The FDA is not aware of any cellular or gene therapies that are made in China for the U.S. market. There are no shortages of biologics to report at this time.

The potential for transmission of COVID-19 by blood and blood components is unknown at this time; however, respiratory viruses, in general, are not known to be transmitted by blood transfusion. Further, there have been no reported cases of transfusion-transmitted COVID-19.

The FDA has made information available to blood establishments and to establishments that manufacture human cells, tissues, or cellular or tissue-based products that may wish to consider additional donor screening measures in response to the COVID-19 outbreak.