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.
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.
