FDA Reports One Drug in Shortage Due to Mfg Issues Related to Coronavirus
As part of its supply-chain surveillance plan for the novel coronavirus (COVID-19), the US Food and Drug Administration (FDA) reports that a manufacturer reported a drug for human use that was recently added to the drug shortages list related to a site affected by coronavirus. The shortage is due to an issue with manufacturing of an active pharmaceutical ingredient used in the drug.
The FDA said in a February 27, 2020 statement that there are other alternatives for the drug. “We are working with the manufacturer as well as other manufacturers to mitigate the shortage,” the FDA said in its statement. “We will do everything possible to mitigate the shortage.”
Since January 24, 2020, the FDA says 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 APIs and other components manufactured in China.
Also, as part of its efforts, the FDA has identified about 20 other drugs, which solely source their APIs or finished drug products from China. The FDA says it has been in contact with those firms to assess whether they face any drug shortage risks due to the outbreak. None of these firms have reported any shortage to date (as of February 27, 2020). Also, these drugs are considered non-critical drugs.
“We will remain in contact with manufacturers so that we can continue to assist them with any potential issues in the fastest way,” said FDA Commissioner Stephen M. Hahn in the February 27, 2020 statement.
The FDA reports that there are 32 animal drug firms that make finished drugs or source APIs in China for the US. The FDA says it has contacted all 32 firms, and no shortages have been reported at this time (as of February 27, 2020). However, the FDA reports that six of those firms have indicated that they are seeing disruptions in the supply chain that soon could lead to shortages. The FDA says it is working with these firms to help identify interventions to mitigate potential shortages.
With respect to medical devices, the agency says it is aware of 63 manufacturers, which represent 72 facilities in China that produce essential medical devices, and the agency has contacted all of them. Essential devices are those that may be prone to potential shortage if there is a supply disruption. It said that it is aware that several of these facilities in China are adversely affected by COVID-19, citing workforce challenges, including the necessary quarantine of workers. The FDA says while it 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 US market, as of the February 27 statement.
Personal protective equipment
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 said in its February 27 statement that it has heard reports of increased market demand and supply challenges for some of these products.
“However, the FDA is currently not aware of specific widespread shortages of medical devices, but we are aware of reports from CDC [US Centers for Disease Control and Prevention] and other US partners of 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 notes that no law exists requiring medical device manufacturers to notify the FDA when they become aware of a circumstance, including discontinuation of a product, that could lead to a potential shortage, and manufacturers are not required to respond when the FDA requests information about potential supply-chain disruption. “As with prior emergencies, the FDA has taken proactive steps to establish and remain in contact with medical device manufacturers and others in the supply chain, including hospitals and group purchasing organizations,” said the FDA in its February 27, 2020 statement.
Biologics and blood supply
The FDA said in its February 27, 2020 statement that is not aware of any cellular or gene therapies that are made in China for the US market. The FDA says there are no shortages of biologics to report at this time (as of February 27, 2020).
With respect to blood products, the FDA says that 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, said the FDA in its February 27, 2020 statement
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.
Source: US Food and Drug Administration