U.S. EpiPen Supply Issue a “Spot Shortage,” says FDA

4615
By:
in Food Allergy
Published: April 30, 2018
Photo: Getty

For the latest update on the EpiPen shortage, see Allergic Living’s article here. 

The U.S. Food and Drug Administration is now calling the availability of EpiPen and Mylan generic epinephrine auto-injectors a “spot shortage.” But the federal agency maintains that “this is not a national shortage” in the United States.

Jeremy Kahn, an FDA press representative, told Allergic Living that pharmacies sometimes report local supply issues called “spot shortages.” They are “usually temporary and involve distribution issues and resolve when the pharmacy is able to reorder from their distributor,” Kahn said.

The FDA tracks national shortages and pharmacies are not required to report drug supply issues to the agency. However, manufacturers must do so, says Kahn. When the FDA receives supply issue reports from pharmacies or hospitals, it checks with manufacturers about supply levels to ensure demand can be met “at the national level.”

“At this time, Mylan is reporting adequate supplies of EpiPen for the U.S., and we will continue to monitor this situation closely,” Kahn told Allergic Living.

However, if the EpiPen supply issue is not national as such, it is certainly affecting numbers of local pharmacies, across both large and regional chains. Allergic Living has heard from several people in New York, New Jersey, Illinois and Texas, as well as a few individuals in each of Ohio, Virginia, Maryland, Massachusetts, Maine, Kentucky, Georgia, Texas, California and Washington. In many cases, pharmacists said the auto-injectors – both the Mylan branded and generic versions – were on back order.

Pfizer Inc. owns the subsidiary that makes the EpiPens the pharmaceutical company Mylan distributes. Pzifer has faced manufacturing delays that have led to shortages in Canada, the U.K. and Australia. In a statement about U.S. supply, Pfizer says: “We are currently shipping product; however, supplies may vary from pharmacy to pharmacy.”

The U.S. supply issue with the Mylan injectors was first reported by the northeast chain Wegmans on April 23. From Allergic Living’s reporting, supply issues seem to be arising more frequently with the adult-size EpiPen, but some consumers also report the EpiPen Jr size for younger children is also on backorder. As no data is being collected on the supply issues, it is difficult to gauge the scale of the problem.

People who are finding it difficult to obtain epinephrine are encouraged to speak to their physician about getting a different auto-injector prescription, advises FARE (Food Allergy Research & Education). To read more about the epinephrine auto-injector options in the U.S., see Allergic Living’s article.

Get more news from Allergic Living to your inbox.  

Related:
U.S. Consumers Report EpiPen Supply Issues: What to Do and Auto-Injector Choices
EpiPen Supply Issues Reported in Some U.S. Regions
Supply Shortage of EpiPen Auto-Injectors in Canada