For the first time since the coronavirus outbreak began, the Food and Drug Administration has reported a shortage of a medicine due to a manufacturing “issue” with an active pharmaceutical ingredient “related to a site affected by coronavirus.” However, the agency did not disclose the name of the medicine, prompting criticism over concerns the lack of information can make it difficult to plan for patient needs.
In a statement issued Thursday night, the FDA explained that an unnamed manufacturer reported a shortage, but did not provide any further details. The statement added that “it is important to note that there are other alternatives that can be used by patients,” and that the FDA is working with the company and other manufacturers to mitigate the shortage.
The failure to release the name of the drug, however, raised hackles.
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It’s “absolutely ridiculous to release something like this without the drug name,” tweeted Erin Fox, who tracks shortages and directs the drug-information service at University of Utah Health Care, which has four hospitals.
“The reason (for having the name of the drug) is it can be a clue as to how long the shortage may last, since drug companies don’t have to provide an expected duration in their notifications. … It’s important to know which drugs are short to make plans for patients.”
An FDA spokeswoman explained the name of the drug is considered confidential commercial information.
“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 spokeswoman wrote us.
“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 discloses commercial confidential information such as drug names, company names or exact location of facilities.”
Shortages have been expected since an estimated 80% of active pharmaceutical ingredients are made in China, where the coronavirus outbreak began and has severely disrupted the global supply chain for all sorts of products. Generics, in particular, are likely to be affected, since Indian drug makers supply much of the copycat medicines to the world, but rely heavily on Chinese ingredients manufacturers.
For the past month, the FDA has issued reminders to more than 180 manufacturers about requirements for notifying the agency of anticipated supply disruptions, and asked them to evaluate supply chains. The also identified about 20 other medicines, which source ingredients or finished drug products solely from China, but none of these are in short supply or are considered critical drugs.
Republished with permission from STAT. This article originally appeared on February 28 2020
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