FDA reveals COVID-19-related drug shortage
The US Food and Drug Administration (FDA) has revealed a COVID-19-related shortage of a drug, adding to concerns that the virus has the potential to massively disrupt medical supply chains.
“A manufacturer has alerted us to a shortage of a human drug that was recently added to the drug shortages list,” said Stephen Hahn, commissioner of the FDA. “The manufacturer notified us that this shortage is related to a site affected by coronavirus.”
Hahn added that the shortage is due to an issue with the manufacturing of active pharmaceutical ingredients (APIs), but added that it’s “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 FDA stated that since late January this year, it has been in touch with more than 180 manufacturers of drugs, to “not only to remind them of the legal requirements for notifying the FDA of any anticipated supply disruptions but also ask them to evaluate their entire supply chain, including APIs”.
The FDA has identified about 20 additional drugs that solely source their APIs or finished drug products from China, the statement added.
A 2019 FDA report estimated that just over 14% of facilities making APIs for the US market were located in China. The EU and India were at 31% each.
“We have been in contact with those firms to assess whether they face any drug shortage risks due to the outbreak, but none of these firms have reported any shortage to date,” said the FDA statement, and “these drugs are also considered non-critical”.
Generics maker Mylan, which also develops APIs, has already warned of drug shortages if the COVID-19 outbreak continues to spread, even though it claimed last week that its exposure to China is limited.
It cited the global nature of its supply chains as a concern, although it claimed that despite facing some logistical issues it had not yet experienced physical shortages.
In February this year, French drugmaker Sanofi announced it was looking to create a new European manufacturer of APIs, amid concerns over-dependence on Chinese manufacturing.
Sanofi will combine six European manufacturing plants into a new standalone company, with sites in France, the UK, Italy, Hungary, and Germany. According to Sanofi, the new firm would rank as the world’s second-largest API manufacturer.
A statement from the French drug company said a new European hub for producing drug ingredients could help balance the pharmaceutical industry’s “heavy reliance on API sourced from the Asian region”.
China is a major supplier of APIs to drugmakers around the world, with some estimates placing a figure of 40% on its share of global production.
The COVID-19 outbreak, despite becoming more widespread, has so far mainly affected China, which has seen the majority of the just-over 81,000 infections, according to the World Health Organization (WHO).
China has seen 2,718 deaths from the virus, while outside the country there have been 44 deaths, spread across 37 countries.
Read all the latest COVID-19 updates in our regularly updated blog here.
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