Amid a major shortage, the Food and Drug Administration said Tuesday that people can keep certain EpiPens past their expiration dates as parents scramble to find the auto-injectors before school starts.
Depending on the batch and amount of medicine in the EpiPen, some of the auto-injectors can now be used up to four months longer than their printed expiration dates in the case of a severe allergic reaction. The FDA shared the list of these newly approved devices.
The FDA came to this decision after Mylan, the distributers of the EpiPen, requested the extension and provided data to show that it would be safe to use them past the listed, 20-month-long shelf life.
“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,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said 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.”
There is currently a shortage of EpiPens due to supply disruptions and manufacturing issues. The FDA announced the shortage in May, and said that based on information from Mylan, they believed the shortage “to be short-term.” But Mylan confirmed on Aug. 8 that it was still ongoing.
On Aug. 16, the FDA approved a generic alternative to the EpiPen for the first time. This version, produced by Israeli company Teva Pharmaceuticals, is also an auto-injector that delivers a dose of epinephrine, but will be sold at a lower price point.
“We are doing everything we can to help mitigate shortages of these products, especially ahead of the back-to-school season,” Woodcock said Tuesday. “The FDA remains committed to using all of the tools available to help prevent and mitigate drug shortages of medically necessary products used to prevent or treat a serious or life-threatening disease or medical condition.”
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Mylan’s shortage follows several tumultuous years for the distributer. While their EpiPens remain the most well-known option for allergy sufferers, the company has been widely criticized for increasing the price by more than 400 percent, from $57 to over $500 since they took over distribution in 2007.
Mylan also had to recall tens of thousands of EpiPens in March 2017 after two separate families reported that theirs failed to work in an emergency. And in Sept., the FDA sent a warning notice to Pfizer, the manufacturers of the EpiPen, because they did not properly investigate issues at a Missouri plant or resolve complaints about failed EpiPens.
The FDA said that they’re hoping to approve more generic autoinjectors to “remove barriers to generic development and market entry of critically important medicines.”