Canada seeks U.S. help to solve EpiPen shortage

[April 18, 2018] By Anna Mehler Paperny

TORONTO (Reuters) - Canada said on Tuesday it is working with the U.S. Food and Drug Administration to access supplies of Mylan N.V.'s EpiPen emergency allergy antidote amid a growing shortage that has spared the United States.

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.

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.

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.

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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