US reports first drug shortage tied to virus outbreak
WASHINGTON (AP) — Health officials reported the first U.S. drug shortage tied to the viral outbreak that is disrupting production in China, but they declined to identify the manufacturer or the product.
The Food and Drug Administration said late Thursday that the drug’s maker recently contacted officials about the shortage, which it blamed on a manufacturing issue with the medicine’s key ingredient. Regulators stressed that alternative medicines are available to treat patients.
The FDA previously said it had reached out to 180 drug manufacturers and asked them to check their supply chain and report any potential disruptions. The agency also said it had identified 20 drugs produced or sourced exclusively from China, but it declined to name them.
The FDA has good reason to not release the names of drugs facing potential shortages, said Rosemary Gibson, who wrote the book “China Rx” on that nation’s role in American health care.
“People might rush to buy it and that would create a worse situation,” said Gibson, a senior adviser at bioethics research group The Hastings Center. “In the context of shortages globally, you have to be very, very careful.”
More than 83,000 COVID-19 cases have been reported worldwide, nearly 79,000 of them in mainland China. Government officials there have severely restricted travel and imposed strict quarantine measures to try and stop the virus from spreading.
Restrictions on movements of people and
goods have been imposed by at least 90 countries, and that’s disrupting
flow of drugs and raw materials, said Nicolette Louissaint, executive
director of Healthcare Ready, a nonprofit group funded by drug
distributors, government and foundations that tracks the impact of
epidemics and natural disasters.
For decades, the pharmaceutical
industry has shifted manufacturing to China, India and other countries
to take advantage of cheaper labor and materials. Today, roughly 80
percent of the ingredients used in U.S. medicines are made abroad,
according to federal figures. India and other Asian nations rely on
Chinese drug ingredients to make finished generic pills.
China
ranks second among countries that send drugs and biotech medicines to
the U.S., according to the FDA. It is also the top exporter of medical
devices and equipment to the U.S.
The country is a major producer
of antibiotics for the U.S. market, as well ingredients and medicines
for common chronic conditions such as heart disease, said Louissaint.
The
virus, which led to strict travel restrictions in Chinese cities home
to more than 60 million people, has affected a range of industries. Some
factories have tried to restart and run into problems getting the raw materials and components they need.
Chinese
factories making pharmaceutical ingredients and drugs are still
operating, with some trying to produce far more than usual and others
still trying to get workers back, Louissaint said Friday. Cargo carriers
are still transporting those products from China to other countries,
she said.
“It is challenging,” but fortunately Chinese ports have remained open, Louissaint said.
She
added that the FDA’s announcement of the shortage indicates the FDA’s
tracking efforts are working and drugmakers are communicating with the
agency.
The FDA said Thursday there are no reported medical device
shortages related to the coronavirus. However, the agency said several
Chinese device manufacturing facilities are being “adversely affected”
by the outbreak due to staffing problems, including workers who have
been quarantined.
The FDA said it is in touch with 63 device
manufacturers with Chinese facilities that produce “essential” medical
devices. While noting increased orders for masks, respirators, gloves
and other protective gear, regulators said there are no reported
shortages of those items in the U.S.
Under a 2012 law, drugmakers are required to notify the FDA of production or sourcing issues that could create medication shortages. The agency noted this week that medical device manufacturers are not bound by that law and “are not required to respond when the FDA requests information about potential supply chain disruptions.”
Johnson reported from Trenton, New Jersey. AP Writer Bernard Condon contributed from New York.