FDA reports shortage of EpiPens, citing 'manufacturing delays'

The manufacturer of Epi Pens faced criticisms regarding its ability to make functional Epi Pens in 2017

"The FDA may not be fully aware of it because the companies that manufacture and distribute the EpiPen are not saying anything", FARE Chief Executive James Baker told Reuters. Mylan is expediting shipment to wholesalers upon receipt, and supply levels may vary across wholesalers and pharmacies.

Mylan, the company that distributes and is the rights holder of EpiPen knows that many people in the United States have had difficulties getting EpiPens, but they don't want to call it a shortage just yet. "However Mylan continues to release the product".

A pharmacist holds a package of EpiPen epinephrine auto-injectors.

Mylan, the company that makes the devices, stressed that the product remains available although there are "intermittent supply constraints".

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Impax Therapeutics generic epinephrine auto-injector in the adult and child sizes are also in shortage, according to the American Society of Health-System Pharmacists on May 3 and now also on the FDA's website.

In a statement released Wednesday, Mylan said it is now receiving continual supply from its manufacturing partner and is expediting shipments to wholesales upon receipt. Reasons for that shortage are not clear, but many consumers have reported buying these devices for the first time in several cases where EpiPens weren't available.

Hundreds of patients in 45 states say they're having trouble finding EpiPens. Pfizer and the FDA maintained there was no national shortage of the lifesaving medication.

"I am now without an epinephrine auto-injector", one patient said. Mylan's revenue from EpiPen dropped sharply over the a year ago due to increased competition, the launch of its own cheaper generic and higher rebates that it has had to pay to as a result of a settlement for overcharging the US government.

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