Mylan’s EpiPen has had a troubled few years—to say the least—with federal prosecutors knocking at the door and shortages plaguing production. Now, with Mylan and Pfizer's generic business Upjohn working on a merger, a new EpiPen manufacturer could be in the cards.
Mylan and Pfizer are in talks to move EpiPen’s production to the new merged generics company, which is expected to take flight in mid-2020. A spokeswoman for Pfizer, which manufactures the drug under its Meridian Medical Technologies unit, said talks are ongoing and terms have yet to be finalized.
EpiPen has faced major production shortages since late 2017, when the FDA found serious issues at the Pfizer plant where the auto-injectors are made. At the time, Pfizer said Meridian was suffering "manufacturing constraints," but it was working with Mylan to improve "consistent availability."
Those shortages presented an opportunity for competitors like Novartis’ Symjepi to step up to meet demand. The challenger drug launched in early 2019 at $250 for a two-pack, compared with more than $600 for branded EpiPen.
Federal prosecutors have also given Pfizer a good reason to dump EpiPen after the U.S. Attorney's Office for the Southern District of New York launched a civil investigation into the drug’s manufacturing in February, citing “alleged quality issues” at the Meridian plant in St. Louis.
The civil inquiry followed a monthslong inspection of the plant’s manufacturing practices, which turned up 171 complaints about EpiPens “misfiring” since the FDA issued its warning letter in 2017. During that investigation, Mylan recalled 80,000 injectors worldwide.
According to the FDA, inspectors found Meridian did nothing to address complaints—which included injectors that spontaneously dispensed epinephrine—or identify the source of the problem.
The FDA also noted that Meridian discovered a defect in one of the critical parts during a routine inspection and passed the investigation off to a supplier after rejecting a few component lots.
Those manufacturing concerns aside, Mylan has also been the focus of a massive price-fixing lawsuit alongside more than 20 generics makers and has drawn Congress’ ire since 2016 after misclassifying EpiPen as a generic and low-balling Medicaid rebates by an estimated $1.27 billion.
After that scandal, Congress approved the Right Rebate Act in April giving the Department of Health and Human Services more oversight of drugmakers' classifications of their products.
Editor's Note: This story has been updated to include comment from Pfizer.