Health Canada is reviewing a decision by the U.S. Food and Drug Administration to approve the expiry date extension for some EpiPen products as pharmacies across North America run out of the life-saving epinephrine auto-injectors.
The FDA approved on Tuesday a four-month extension of expiration dates for specific lots of 0.3 mg EpiPens marketed by Mylan that are expired or close to expiring.
“We are doing everything we can to help mitigate shortages of these products, especially ahead of the back-to-school season,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, in a statement. “We’re hopeful this action will ensure patients have access to this important medication and provide additional peace-of-mind to parents as the agency works with the manufacturer to increase supply.”
In a statement to CTV News, Health Canada spokesperson André Gagnon said the agency is aware of the FDA notice and is working with Pfizer, the drug company that produces the EpiPen, to assess the information. Each country has its own regulatory process for drug approval, which includes any changes in product instructions for use.
“Health Canada will communicate a decision regarding the extension of the expiry date once we review the data that formed the basis of the FDA decision,” the statement said.
Pfizer Canada spokesperson Christina Antoniou told The Canadian Press in April that it’s not unusual to have short periods of reduced supply of the auto-injector. “There’s a relatively short shelf-life on it of 12 to 18 months,” she said, “so between the relatively short shelf-life and managing the inventory supply, it’s quite normal for us to experience periods of limited supply.”
Canada has been experiencing a shortage of EpiPens since at least January.
— FDA Drug Information (@FDA_Drug_Info) August 21, 2018
Currently, the supply of EpiPen® (epinephrine injection, USP) Auto-Injector 0.3 mg & the authorized generic version in the US varies from pharmacy to pharmacy. Dr. Freda Lewis-Hall comments on situation. More info on #EpiPen here: https://t.co/kfMbAFVdLI or call 1-800-796-9526 pic.twitter.com/w7YIrqZRyC
— Pfizer Inc. (@pfizer) August 21, 2018