By Bill Berkrot
NEW YORK (Reuters) – Mylan N.V.’s
EpiPens deliver potentially lifesaving doses of the generic drug epinephrine, via an automatic injector that a patient or caregiver can administer in the event of severe allergic reaction.
“We are shipping product. Currently there is no shortage in the U.S.,” said Steve Danehy, a spokesman for Pfizer Inc
Mylan is in charge of managing allocation of the EpiPen supply, Danehy said in an email to Reuters. It was not immediately clear why Canada and the UK would be subject to a shortage at this time. A Mylan spokeswoman was not available for comment.
Mylan’s EpiPen sales practices in the United States sparked public outrage in 2016 as consumers saw the price for a pack of two auto-injectors rise sixfold to $600 in less than a decade, making the devices unaffordable for a growing number of families.
Since then, the company has launched a generic version of EpiPen for half the price, though the U.S. market is still the most lucrative.
Meridian Medical Technologies Inc, the unit of Pfizer that manufactures EpiPens, has been hit by a series of manufacturing problems. In March 2017, Mylan recalled tens of thousands of devices after complaints that some had failed to activate.
In September, Meridian received a warning letter from the U.S. Food and Drug Administration. The FDA said Meridian had failed to thoroughly investigate product failures, including EpiPen products that were associated with patient deaths and severe illnesses. It said the company failed to take corrective actions until FDA’s inspection.
At the time, Mylan said it did not anticipate any impact on EpiPen supply based on the warning letter.
But on Thursday, Pfizer Canada said it was “experiencing supply constraints” for EpiPens used by both adults and children “due to delays at the manufacturing facility,” as well as problems in sourcing a component for the device from an outside supplier.
There are no alternatives on the market in Canada, federal health officials there said. They advised patients and caregivers to use expired EpiPens in an emergency if they have nothing else on hand, and then call 911.
“Pfizer understands and regrets the challenges that these ongoing supply constraints pose to patients and the healthcare community,” the company said in a statement on its website.
On Friday, the UK website for EpiPen notified consumers of “intermittent supply constraints” for the adult injector. It said the next shipment to EpiPen’s distributor in the country was expected toward the end of April.
Mylan’s revenue from EpiPen dropped sharply over the last year 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 U.S. government.
(Reporting by Bill Berkrot and Michael Erman in New York, Yasmeen Abutaleb in Washington and Anna Mehler Paperny in Toronto; Writing by Michele Gershberg)