The Food and Drug Administration (FDA) is closely monitoring the supply chain of critical medical products with the expectation that the COVID-19 outbreak will likely impact supply and create shortages in the United States, FDA Commissioner Dr. Stephen M. Hahn said in a news release.
The FDA has been in touch with more than 180 human drug manufacturers since Jan. 24, making them aware that they should evaluate their entire supply chain and notify the agency if they anticipate any disruptions in their supply of products. This includes active pharmaceutical ingredients (the main ingredient in drugs) and other components manufactured in China.
At least one manufacturer has alerted the FDA of a drug shortage related to a site affected by coronavirus. “It is important that we note there are other alternatives that can be used by patients,” Hahn said. “We are working with the manufacturer as well as other manufacturers to mitigate the shortage.”
About 63 manufacturers representing 72 facilities in China that produce essential medical devices have been contacted by the FDA. Several are adversely affected by COVID-19 and are experiencing workforce challenges due to necessary quarantine of workers. As of now, there are no reported shortages for these types of medical devices within the U.S.
“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 has heard reports of increased market demand and supply challenges for some of these products,” Hahn said. “However, the FDA 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 increased ordering of a range of human medical products through distributors as some health care facilities in the U.S. are preparing for potential needs if the outbreak becomes severe.”
The FDA is also not aware of any reports of human illness that would suggest COVID-19 can be transmitted by food or food packaging. “However, it is always important to follow good hygiene practices (i.e. wash hands and surfaces often, separate raw meat from other foods, cook to the right temperature, and refrigerate foods promptly) when handling or preparing foods,” he said.
There have also been no shortages reported by the 32 animal drug companies that make finished drugs or source active pharmaceutical ingredients in China for the U.S. However, six of the companies have indicated that they are seeing disruptions in their supply chain that could lead to shortages. “The FDA is working with these firms to help identify interventions to mitigate potential shortages,” Hahn said.
Finally, the FDA said it would continue to aggressively monitor the market for any companies marketing products with fraudulent COVID-19 treatment, preventative, or diagnosis claims. Earlier this week, the agency sent warning letters to several companies for this issue.
“Overall this remains an evolving and very dynamic issue,” Hahn said, adding that the agency would continue to provide the public with updates as they come available.