For the first time since the coronavirus outbreak began, the Food and Drug Administration
reported shortage of a medicine due
to a manufacturing “issue” An active
pharmaceutical ingredient “related to a site
affected by coronavirus.” The agency
did not disclose the name of the medicine,
prompting criticism for concerns of having
lack of information may result to
difficult plan with regards to patient's need.
In a statement issued late on 27th Feb,
the FDA told that an unnamed manufacturer
reported a shortage, but it did not provide
any further details. During statement added that
“it is important to note that there are other
alternatives that can be used by patients,”
and the FDA is working with the drug
company and other manufacturers to
fill in the shortage.
However, the failure to release the name of the drug,
raised hackles.
It was “absolutely ridiculous to release something
like this without the drug name,” tweeted Erin Fox,
who tracks shortages and directs
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 expected duration in their
notifications. … It is important to know which
drugs are short to make plans for patients.”
An FDA spokeswoman said that 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,”
spokeswoman told.
“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.”
The shortages have been expected since an
estimated 80% of active pharmaceutical
ingredients are made in China, where the
coronavirus outbreak began and has
severely affected the global supply chain
for all sorts of products.
Generic drugs, in particular,
are likely to be affected, since the Indian drug
makers supply much of the copied medicines
to the world, but rely heavily on Chinese
ingredients manufacturers.
During the past month, FDA has issued
reminders to more than 180 manufacturers
regarding requirements for notifying the agency
of anticipated supply disruptions, and ordered
them to evaluate supply chains.
They 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.
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