FDA Watching Medical Supply Chain Closely for Coronavirus Disruptions
The Food and Drug Administration “has been closely monitoring the supply chain with the expectation that the COVID-19 [coronavirus] outbreak would likely impact the medical product supply chain, including potential disruptions to supply or shortages of critical medical products in the U.S.,” FDA Commissioner Stephen Hahn said in a news release. The agency has communicated with more than 180 drug manufacturers to remind them about notification requirements for supply disruptions, it said. “Also, 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,” it said. “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 have reported any shortage to date. Also, these drugs are considered non-critical drugs.”
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The FDA is also “aware of 63 manufacturers which represent 72 facilities in China that produce essential medical devices” and has contacted all of them, it said. While there's no supply disruption requirement for medical devices, the FDA said it proposed such a requirement within the administration's budget request. It also proposed “empowering the FDA to require information to assess critical infrastructure, as well as manufacturing quality and capacity.” The FDA said it is “not aware of any reports at this time of human illnesses that suggest COVID-19 can be transmitted by food or food packaging.”