FDA extends shelf life of some EpiPens: Alex Azar

By Health CareFOXBusiness

FDA extending expiration dates on certain EpiPen lots: Alex Azar

HHS Secretary Alex Azar on Trump administration efforts to reduce drug prices, President Trump calling on the Justice Department to sue opioid makers and the EpiPen shortage.

The U.S. Food and Drug Administration will extend the expiration date of some EpiPens in order to help alleviate the burden caused by a mass shortage of the life-saving medication, according to Health and Human Services Secretary Alex Azar.

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“We’re quite concerned about the EpiPen shortage,” Azar said during an interview on Tuesday with FOX Business’ Stuart Varney.

The allergy-treatment drug is manufactured by a subsidiary of Pfizer and marketed by Mylan, which came under fire in 2016 for a series of drastic price hikes.

But since May, there have been shortages of EpiPen, which is largely chalked up to manufacturing and supply problems. Another issue: The drug expires 18 months from the date of manufacturing, and now there are parents who can’t find new ones to purchase for their children.

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According to a report from The Washington Post, Mylan CEO Heather Bresch -- fresh off the heels of national criticism -- began petitioning in 2016 to extend the shelf life for EpiPen. Doing so may not only help curtail a rising shortage, but quell frequent criticisms from families who have to throw out unused EpiPens each year and buy new ones.

Azar said parents should seek guidance from the FDA as to which makes of EpiPen will have their usage date extended, but declined to comment further.

And less than one week ago, on Thursday, the FDA approved the first generic version of EpiPen, which will be produced by Teva Pharmaceuticals.

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“I have directed the FDA to use all of its regulatory tools at its disposal to bring relief to parents and children as they go back to school here,” Azar said. “You’ll be seeing action on that very soon.”

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