There is a shortage of EpiPens in the U.S. due to manufacturing issues, Bloomberg reported on Tuesday. Some patients say they’ve had to wait weeks to get the device, while others haven’t been able to find it at all.
James Baker, CEO of the Food Allergy Research & Education advocacy group, told the outlet that more than 400 patients in 45 states have reported experiencing problems in filling prescriptions for the medical devices since May 2.
Mylan, the company that owns the rights to EpiPens, told the Food and Drug Administration months ago that manufacturing delays were leading to issues with the supply. A spokesperson told Bloomberg, “Mylan and Pfizer have remained in close contact with FDA to provide regular updates on the inventory status.” The FDA has, in turn, claimed that Mylan is reporting “adequate supplies” of EpiPen in the U.S. The device has not been placed on the agency’s list of drug shortages.
Pfizer, which makes EpiPens for Mylan, further told Bloomberg that it had changed its manufacturing process in response to a September warning letter from the FDA. The FDA had found that Pfizer failed to investigate hundreds of reports concerning faulty EpiPens, including cases in which people were killed or injured. A spokesperson for Pfizer said that “there has been some impact on manufacturing capacity” due to the changes. Yet, he also claimed that shipments have been increasing recently and that they beat expectations for April.
Reuters reported on April 13 that there was a shortage of EpiPens in the UK and Canada, though Mylan had claimed at the time that there were no such issues in the U.S.
Mylan has, in the past, come under fire for raising the price of EpiPens from an average of $50 to more than $300 over the course of a decade. The device accounted for 40 percent of the company’s profits in 2015. The company released a generic version of the product in 2016 for $150.