Potential supply chain shortages from coronavirus being 'closely monitored' by FDA

by Thomas Dworetzky, Contributing Reporter | March 03, 2020
Business Affairs Risk Management
The FDA is now “closely monitoring” the medical supply chain in anticipation that the coronavirus (COVID-19) would lead to “potential disruptions to supply or shortages of critical medical products in the U.S.,” according to FDA Commissioner Dr. Stephen M. Hahn.

Since January 24, the agency has reached out to over 180 manufacturers of human drugs, “asking them to evaluate their entire supply chain,” for components made in China — and to remind them of a “regulatory obligation” to tell the agency if they might face such a disruption.

At present there are about 20 drugs that have been identified that get their active ingredients or finished products from China — but these are all considered “non-critical.”

In addition there are 63 manufacturers making “essential medical devices” in China and all are in touch with the agency, as it “continues to assess” potential manufacturing disruptions that could cause problems, although at present, the agency advised, there are no reported shortages in U.S. markets.

Some panic buying in the general public is also putting pressure on types of personal protective gear, including “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,” according to the agency.

But at present, FDA says that it “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 healthcare facilities in the U.S. are preparing for potential needs if the outbreak becomes severe.”

In addition, at present the agency is not aware of any cellular or gene therapies produced in China for the U.S. market, and there are no reports of biologics shortages.

The agency did report the first official COVID-19-related drug shortage, however. Said Hahn, “the shortage is due to an issue with manufacturing of an active pharmaceutical ingredient used in the drug,” Hahn said in a statement Thursday night. “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.”

The sudden threat of the virus, may, however, spur some positive action in congress to pass the Mitigating Emergency Drug Shortages (MEDS) Act — stalled in the Senate Health, Education, Labor and Pensions Committee since October 2019.

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