According to people familiar with the matter, Mylan sent a team of managers to Pfizer's plant in St Louis, Missouri in an effort to solve manufacturing issues that have led to shortages of EpiPen, the Financial Times reported. One of the sources suggested that Mylan sent the team as its managers sensed a lack of urgency among their counterparts at Pfizer.
Earlier this month, the FDA added EpiPen to its drug shortage list, noting that the product has "intermittent supply constraints due to manufacturing delays from the manufacturing partner." The shortages come after Pfizer's Meridian Medical Technologies unit, which manufactures the EpiPen auto-injector, received a warning letter from the agency over violations related to the manufacturing of the device.
In response to the latest news, Mylan and Pfizer said "we are working together, as we have throughout our long collaboration, to increase production and expedite shipments as rapidly as possible." The companies added that their partnership had "always included frequent interactions such as visits to each other's sites."
Commenting on the matter, Bernstein analyst Ronny Gal said "this product has had decades of manufacturing issues that Pfizer has never fixed." Gall added "this is actually a life-saving, mission-critical product and it is Pfizer's fault — but it is casting Mylan in a bad light when they already have a reputation problem." Mylan has previously faced criticism in the US regarding price hikes on EpiPen, with the company subsequently introducing an expanded access programme and launched an authorised generic of the product priced at a 50-percent discount.
Pfizer has also been working to resolve issues at a manufacturing facility in McPherson, Kansas that have been linked to shortages of Amneal Pharmaceuticals' similar epinephrine auto-injector Adrenaclick. A representative at Amneal explained that the company was "not pleased by the shortages" and that it was "trying to resolve them by working with the manufacturer and the FDA."
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