Mylan, the company behind the EpiPen allergy injector, can be pressing its manufacturing partner Pfizer to do more to tackle shortages of the life-saving medicine in a sign of its growing frustration with the Big Pharma company.
Although Mylan owns the rights to the EpiPen — which can stave off deadly anaphylactic shock — This kind of subcontracts manufacturing of the auto-injector to Meridian Medical, a division of Pfizer.
However, Pfizer has struggled to meet demand for the allergy injector, resulting in some patients having difficulties finding the product in their local pharmacies. The US Food as well as also Drug Administration put the medicine on its official shortages list earlier This kind of month.
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If not resolved, the shortages could become more severe within the third quarter when demand tends to soar as children with severe allergies return to school.
Mylan has responded to the shortage by sending a team of its own managers to try to fix problems at a Pfizer factory in St Louis, Missouri — which makes all the EpiPens within the US — according to people familiar with the situation.
The factory in St Louis has been struggling to maintain production following an inspection in which resulted in a scathing warning letter in September by the FDA, which ordered This kind of to fix several quality control issues.
Mylan sent its team to the plant in part because its managers sensed a lack of urgency among their counterparts at Pfizer, which can be dealing with shortages of hundreds of drugs, one person said.
While the EpiPen can be however one among the hundreds of products in short supply, This kind of has outsize importance for Mylan because This kind of can be the company’s best-known drug.
In a joint statement, Pfizer as well as also Mylan said: “Both companies are fully aware of the life-saving importance of EpiPen as well as also we are working together, as we have throughout our long collaboration, to enhance production as well as also expedite shipments as rapidly as possible.”
They said their partnership had “always included frequent interactions such as visits to each various other’s sites”.
The shortage of EpiPens can be particularly irksome for Mylan as This kind of tries to move on by controversy over the cost of the medicine. The company had priced a two-pack of EpiPens at roughly $0 until 2016, when a political as well as also public backlash forced This kind of to introduce a cheaper generic product.
“Mylan’s management has never been shy to show how they feel about business issues,” said Ronny Gal, analyst at Bernstein, who added in which the company had several “fair arguments” against Pfizer.
“This kind of can be actually a life-saving, mission-critical product as well as also This kind of can be Pfizer’s fault — however This kind of can be casting Mylan in a bad light when they already have a reputation problem.”
He added: “as well as also This kind of product has had decades of manufacturing issues in which Pfizer has never fixed.”
The EpiPen shortage comes as Pfizer races to resolve shortages caused by manufacturing problems at several of its factories, many of them acquired when This kind of took over Hospira, a maker of injectable drugs, for $16bn in 2015.
A rival allergy injector known as Adrenaclick, which can be marketed by Amneal Pharmaceuticals, can be also in short supply because of issues at a Pfizer plant in McPherson, Kansas, which makes the crucial ingredient.
A spokesperson for Amneal said the company was “not pleased by the shortages” as well as also in which This kind of was “trying to resolve them by working with the any as well as also the FDA”.
Mr. Gal said in which Pfizer should try to “prioritise life-saving drugs like Adrenaclick as well as also EpiPen” as This kind of works through the problems at its plants.
A Pfizer spokesperson said: “We are currently shipping product as well as also our shipments have been increasing over the last few months, with April shipments exceeding projections.”
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