EpiPens deliver a potentially lifesaving dose of the generic drug
epinephrine via an automatic injector. They are made at a single
Pfizer Inc facility near St. Louis, Missouri.
Last week, Pfizer notified consumers in Canada and Britain that the
device is in short supply due to manufacturing problems. In response
to a Reuters query, Pfizer said there was no shortage in the United
States and that Mylan decides how EpiPens are allocated to different
countries.
The restricted supply is particularly worrying to doctors and
families in Canada, where no alternatives to the EpiPen are sold.
Health Canada has told consumers to use expired EpiPens and call 911
in an emergency if they have nothing else.
"There's not a robust supply in Canada. And there may not be for a
while," said David Fischer, president of the Canadian Society of
Allergy and Clinical Immunology. He said some Canadians had trouble
accessing EpiPens starting in February.
"We're all perplexed about the whole concept of this worldwide
shortage that does not involve the U.S.," Fischer said.
The U.S. market is the most lucrative for EpiPen, where a two-pack
of the generic injectors retails for $300. In Canada, a single
EpiPen can be bought for $100, while the UK National Health Service
price for a single dose is closer to $38.
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Health Canada, the government health department, is discussing with
Pfizer and the FDA ways to minimize the impact of the shortage,
"including exploring access to international supply," Rebecca Purdy,
a Health Canada spokeswoman, said.
Pfizer Canada spokeswoman Kerri Elkas said the company "is working
diligently to increase production and expedite shipments to Canada
as rapidly as possible."
Officials at Mylan and the FDA were not immediately available for
comment.
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RECALLS, MANUFACTURING LAPSES
Meridian Medical Technologies Inc, the Pfizer unit that manufactures
EpiPens, has been hit by a series of manufacturing problems. In
March 2017, Mylan recalled tens of thousands of devices after
complaints that some failed to activate.
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In September, Meridian received an FDA warning letter saying it had
failed to thoroughly investigate product failures or take corrective
actions until the FDA's inspection. At the time, Mylan said it did
not anticipate any impact on EpiPen supply.
Health Canada said four companies have authorization to sell
epinephrine auto-injectors -- Kaleo Pharma, Taro Pharmaceutical
Industries Ltd, Valeant Pharmaceuticals International Inc and
Lincoln Medical Ltd -- but none are currently marketing them in the
country.
In the UK, two rival products are approved for sale from Danish
drugmaker ALK-Abello and from Valeant's Bausch and Lomb division.
In Toronto, Amy Morrell keeps four EpiPens to protect her 5-year-old
son from a life-threatening peanut allergy. She keeps them at home,
at his school and in his backpack.
She has not had trouble yet filling a prescription. But if supply
were disrupted, she said, "it just wouldn't be acceptable.
"We wouldn't be able to leave the house," she said. "It would be
life-changing - for him, and for us."
(Reporting by Anna Mehler Paperny; Editing by Michele Gershberg,
Lisa Shumaker and Leslie Adler)
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