FDA reports first drug shortage due to coronavirus

On February 27, 2020, FDA announced the first reported drug shortage brought on by the recent COVID-19 outbreak. The agency did not identify the drug but stated that the shortage is “due to an issue with manufacturing of an active pharmaceutical ingredient used in the drug” and is “related to a site affected by coronavirus.” FDA assures that there are alternative drugs patients can use during the shortage, and that it is doing everything possible, including working with manufacturers, to mitigate the issue.

FDA stated that it is closely monitoring the drug supply chain amid the COVID-19 outbreak. It expects that the outbreak will likely affect the medical product supply chain, including possible disruptions to supply or shortages of drugs or essential medical devices.

As part of wider efforts, the agency said it has been in touch with more than 180 drug manufacturers since January 24 and is asking them to evaluate their entire supply chain, especially active pharmaceutical ingredients and other components manufactured in China.

FDA has identified about 20 other drugs that “solely source their active pharmaceutical ingredients or finished drug products from China.” It has also identified 63 manufacturers representing 72 facilities in China that produce essential medical devices. Some of these facilities have been affected by the outbreak, particularly as a result of the necessary quarantine of workers. The agency has contacted these firms to determine if they are facing risks of shortages. As of press time, none has reported any shortages.