Coronavirus has caused drug shortage, says FDA chief

The FDA has announced the first drug shortage caused by the COVID-19 coronavirus outbreak, following previous warnings about its impact on the drug supply chain.

In a statement the FDA’s commissioner Stephen Hahn said that an unnamed manufacturer has flagged a shortage of a human drug, related to a site affected by coronavirus.

According to Hahn the drug had recently been added to a list of drugs in short supply maintained by the FDA.

Hahn said the shortage is due to an issue with manufacturing of an active pharmaceutical ingredient (API) used in the drug.

There are alternative therapies that could be used by patients, according to Hahn, who said the FDA is working with the manufacturer to mitigate the shortage.

Manufacturers are legally required to notify the FDA of any anticipated supply disruptions, and the regulator has asked them to evaluate their entire supply chain, including API, and other components manufactured in China.

The FDA has identified about 20 other drugs which are made from API only manufactured in China, and has been in contact with their manufacturers to assess whether they face any shortage risks due to the outbreak.

There is also a potential threat to the supply of medical devices too: Hahn said the FDA knows of 63 manufacturers, across 72 facilities, that produce devices classed as “essential”.

These are devices that may be prone to shortages if there is a supply disruption.

However for now there are no current reported shortages for these types of devices within the US, Hahn said.

Earlier this week, a report from ratings firm Moody’s predicted that supplies of APIs for generic drugs will be affected by coronavirus.

Just how serious the shortages will be depends on how far the virus spreads from “ground zero” in Wuhan.

Moody’s believes most active pharmaceutical ingredient (API) manufacturers are based in China’s northern Shandong and eastern Jiangsu and Zhejiang provinces.

Wuhan is based in the central province of Hubei but the virus has been detected in all of China’s provinces, including those with big pharma manufacturing hubs.

Coronavirus has already had an impact on stock markets, which slumped across the world amid fears over the impact of the disease.

Bank of England governor Mark Carney warned the outbreak could lead to a downgrade of the UK’s economic growth prospects.

 

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