FDA reports first coronavirus-related drug shortage
The US Food and Drug Administration has reported the first case of a pharmaceutical drug shortage directly related to the global coronavirus (COVID-19) outbreak that is threatening to reach pandemic status.
In a supply chain update, the agency’s commissioner of food and drugs, Stephen Hahn said a manufacturer had alerted the FDA to an unnamed human drug that has recently been added to the drugs shortages list.
“The manufacturer just notified us that this shortage is related to a site affected by coronavirus,” he said. “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,” he continued. “We are working with the manufacturer as well as other manufacturers to mitigate the shortage. We will do everything possible to mitigate the shortage.”
Over the last month, the FDA has been talking to over 180 pharmaceutical manufacturers to remind them of the legal requirements for communicating any anticipated supply disruptions and asking them to evaluate their entire supply chains, including APIs and other components manufactured in China, where the virus first emerged.
The FDA has so far identified about 20 drugs -- all of which have been deemed non-critical -- which solely source their APIs or finished drug products from China, Hahn said, adding that so far none of their manufacturers have reported any shortages.
The World Health Organisation has declared the outbreak a global health emergency, with WHO director-general Dr Tedros Ghebreyesus saying coronavirus has “pandemic potential.”
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance