The EpiPen , a life - saving medical mathematical product for treat severe allergies , is in short supply as American nipper head back to school . But Mylan , the pharmaceutical society that have the EpiPen , has come up with a solution to the dearth : Expand the departure escort on some of its products . The U.S. Food and Drug Administration ( FDA ) has approved the extension of four month on some of its EpiPens , but it ’s significant to observe that it does n’t apply to every equipment .
“ Mylan submitted extra data to the FDA to show specific lot of its EpiPen product remained stable , retaining its metier , quality and purity for up to 24 months when stored according to its labeled storage consideration , ” FDA spokesperson Theresa Eisenman told Gizmodo over email .
EpiPens have a printed shelf lifespan of 20 months , but some will now be deem effective at 24 months . The specific lot numbers for the EpiPens that can be used for up to four months beyond their termination dates can be determine at theFDA web site .
How can the expiration date on a product like the EpiPen get extended ? Is the exact date arbitrary ? A interpreter from Pfizer , which manufacturers the EpiPen for Mylan , told Gizmodo that they were able to offer the escort because of their rigorous examination .
“ It is sometimes possible to extend expiration date in cases where long - condition stability written report have provided sufficient datum to affirm the expiration date extension . It ’s also possible , in some cases , to conduct stableness testing beyond the filed release date to specify whether the file expiration period may be extended . Product expiration dates are not indiscriminately set shorter than what the stability data documentation , ” Pfizer spokesperson Steven Danehy tell Gizmodo over email .
“ The expiration appointment for a given product is coiffure base on studies we run to measure a product ’s shelf stability over metre , ” Danehy continued . “ A product ’s ledge stability period is supply to a lot ’s manufacturing date to calculate the expiration date . stableness data is collected for each product and is used to support the termination period specified in regulatory filing . ”
Consumers are encouraged to keep expired EpiPens on hand if they have n’t been able to get a new prescription for one reason or another . An expired EpiPen is better than no EpiPen in a life-time - threatening situation .
Mylan became a household name to anyone with severe allergies after it was incriminate of damage - gouging in the summer of 2016 . The company had raise the Leontyne Price on the aliveness - saving product from just about $ 57 in 2007 to over $ 600 in 2016 . Heather Bresch , Mylan ’s top executive director , even had to take the stand in front of Congress about the prices , though she face no consequences for lying about how much the companionship was really making on each EpiPen sold . Defects in the ware thefollowing yearhelped lead to a shortage that has never truly been recover from .
“ We are doing everything we can to facilitate mitigate shortages of these products , especially out front of the back - to - schoolhouse time of year , ” Janet Woodcock , music director of the FDA ’s Center for Drug Evaluation and Research , order in apress release . “ We ’ve finish the necessary review of the data to extend the expiration date by four months for specific lots of EpiPen that are expired or stuffy to expiring . ”
“ We ’re hopeful this natural process will ensure patients have admittance to this crucial medication and leave extra peace - of - nous to parents as the agency works with the maker to increase supply . ”
[ FDA ]
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