What’s behind the persistent shortage of lifesaving EpiPens

Mylan NV and Pfizer Inc. are still struggling with manufacturing issues for the EpiPen anti-allergy injector as the critical back-to-school season gets underway and a rival generic product hits the market.

EpiPens, which can help stop a severe or life-threatening allergic reaction, have been hard to get since at least May 2018, when the U.S. Food and Drug Administration said the device was in short supply. Former and current employees of Pfizer’s Meridian Medical Technologies Inc., which makes the product for Mylan, said supply has been unsteady since at least 2017, when inspectors began noticing defects.

“Our production output is improving,” Pfizer spokeswoman Amy Rose said. “However, we anticipate supply to be tight as we enter the peak demand season.”

Consumers have been forced to adjust. While other options are available, patients switching to other devices face uneven distribution, the reluctance of insurers to pay for similar treatments and uneasiness with unfamiliar products.

Teva Pharmaceutical Industries Ltd., which already makes a generic EpiPen, began selling a copycat version of Mylan’s EpiPen Jr. for small children on Aug. 20.

“We will continue working to ensure availability of both strengths in the U.S. and plan to accelerate production to meet the urgent need for this medicine,” Brendan O’Grady, Teva’s executive vice president and head of North American commercial, said in a statement.

Each year in the U.S., 200,000 people require emergency medical care for allergic reactions to food, according to Food Allergy Research & Education, an advocacy group. More than 40% of children with food allergies have experienced a severe reaction such as anaphylaxis, the group said.

The EpiPen shortage can be traced at least in part to two factories in Missouri. The Mylan EpiPen, EpiPen Jr. and its generics are all manufactured near St. Louis. The devices are produced at a plant in Brentwood and inspected at a site in Westport.

The three-step inspection process begins with the devices being scanned by a machine for defects. The EpiPens then move along a conveyor belt while inspectors look at the devices under magnification. Lastly, the inspectors hold a handful of units to look for deficiencies.

A former employee, who left the company about two years ago, said workers were expected to successfully inspect about 4,000 EpiPens a day in 2016. About every day-and-a-half, the employee said, the plant was able to put out a new batch of EpiPens — as many as 90,000 devices.

But that changed in 2017 when inspectors began noticing chips in the glass cartridges of the devices, the inspector said. Other issues followed, the employee said, such as bent or broken needles.

An FDA warning letter was sent to Meridian in September 2017 that “summarizes significant violations of good manufacturing practice” found in inspections from Feb. 20 to March 24, 2017.

EpiPens, which contain the hormone epinephrine (also known as adrenaline), are used to stave off allergic reactions that can in some cases kill. Complaints of EpiPen failures skyrocketed between 2016 and 2017, and included deaths allegedly linked to device malfunctions.

After a series of changes to the process, the former employee said supply dropped to one new batch of EpiPens about every two to three days, and a current employee interviewed by Bloomberg said problems continue to plague the plant.

Rose, the Pfizer spokeswoman, declined to comment on the manufacturing process.

A current inspector, who also requested anonymity, said batches of EpiPens have failed to eject and that entire lots of the devices were dumped in the trash.

At the end of November 2018, a little over a year after the FDA warning letter was issued, the Brentwood manufacturing plant was shut down for its typical two-week maintenance period.

While inspectors routinely have a backlog of work to do, the employee said, they ran out of product to inspect by the second week of December. The next week, supervisors indefinitely laid off all inspectors.

Meridian, meanwhile, is working to improve the conditions. The current inspector was brought back earlier this year, and there are now 20-30 inspectors per shift.