The EpiPen, a life-saving medical product for treating severe allergies, is in short supply as American kids head back to school. But Mylan, the pharmaceutical company that owns the EpiPen, has come up with a solution to the shortage: Expand the expiration date on some of its products. The U.S. Food and Drug Administration (FDA) has approved the extension of four months on some of its EpiPens, but it’s important to note that it doesn’t apply to every device.
“Mylan submitted additional data to the FDA to show specific lot of its EpiPen product remained stable, retaining its strength, quality and purity for up to 24 months when stored according to its labeled storage conditions,” FDA spokesperson Theresa Eisenman told Gizmodo over email.
EpiPens have a printed shelf life of 20 months, but some will now be deemed effective at 24 months. The specific lot numbers for the EpiPens that can be used for up to four months beyond their expiration dates can be found at the FDA website.
How can the expiration date on a product like the EpiPen get extended? Is the exact date arbitrary? A representative from Pfizer, which manufacturers the EpiPen for Mylan, told Gizmodo that they were able to extend the dates because of their rigorous testing.
“It is sometimes possible to extend expiration dates in cases where long-term stability studies have provided sufficient data to support the expiration date extension. It’s also possible, in some cases, to conduct stability testing beyond the filed expiration date to determine whether the filed expiration period may be extended. Product expiration dates are not arbitrarily set shorter than what the stability data support,” Pfizer spokesperson Steven Danehy told Gizmodo over email.
“The expiration date for a given product is set based on studies we run to measure a product’s shelf stability over time,” Danehy continued. “A product’s shelf stability period is added to a lot’s manufacturing date to calculate the expiration date. Stability data is collected for each product and is used to support the expiry period specified in regulatory filings.”
Consumers are encouraged to keep expired EpiPens on hand if they haven’t been able to get a new prescription for one reason or another. An expired EpiPen is better than no EpiPen in a life-threatening situation.
Mylan became a household name to anyone with severe allergies after it was accused of price-gouging in the summer of 2016. The company had raised the price on the life-saving product from roughly $57 in 2007 to over $600 in 2016. Heather Bresch, Mylan’s top executive, even had to testify in front of Congress about the prices, though she faced no consequences for lying about how much the company was actually making on each EpiPen sold. Defects in the product the following year helped lead to a shortage that has never truly been recovered from.
“We are doing everything we can to help mitigate shortages of these products, especially ahead of the back-to-school season,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a press release. “We’ve completed the necessary reviews of the data to extend the expiration date by four months for specific lots of EpiPen that are expired or close to expiring.”
“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.”