Around 10 PM ET last night, the FDA said that it is aware of a drug shortage related to an active pharmaceutical ingredient (API) manufacturer affected by the coronavirus, but the agency stopped short of revealing what drug it is.
“The shortage is due to an issue with manufacturing of an active pharmaceutical ingredient used in the drug. 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. We will do everything possible to mitigate the shortage,” FDA Commissioner Stephen Hahn said in a statement.
An FDA spokesperson also confirmed to Focus that the agency cannot disclose the drug in shortage “as it is confidential commercial information.”
But she also explained why the FDA is in a difficult position with respect to such shortages and keeping the public informed.
“While manufacturers are legally required to report drug supply disruptions to FDA, they are not required to provide the detailed information on their supply chain that we have needed to monitor the drug supply since the onset of the outbreak,” the spokesperson said. “We need the cooperation of the drug companies in order to obtain accurate information as we proactively take steps to mitigate drug shortages, and companies will be less willing to provide this voluntary information if they cannot trust FDA not to disclose commercial confidential information such as drug names, company names or exact location of facilities.”
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