A persistent shortage of Mylan's EpiPen anti-allergy injectors is forcing patients and pharmacists to go to great lengths to get their hands on the lifesaving device.
EpiPens, which can help stop a severe or life-threatening allergic reaction, have been hard to get since at least May 2018, when the Food and Drug Administration said the device was in short supply. While other options are available, including an identical lower-priced version of the device from Mylan, consumers have also struggled to secure alternatives thanks to uneven distribution, the reluctance of insurers to pay for similar treatments and uneasiness with unfamiliar products.
Even patients who live near numerous pharmacies have been scrambling. Boston resident Justin Klaassen said he drove 45 minutes outside the city earlier this year to find EpiPens for his 7-year-old daughter. Everywhere he called within 10 miles of Boston was out of stock of the device, which carries a list price of more than $600 for a two-pack but has been scarce because of manufacturing problems.
"My family has enough money to buy one with insurance, you know, and even two because you want one at school and you want one at home," Klaassen said. "But there are families out there who can't even afford one, and then you have the problem finding them."
EpiPens can be especially difficult to track down at the start of a new school year, when sales tend to peak. Teachers and staff in school districts across the U.S. have been trained to use the devices, while few have been shown how to use rivals like Adrenaclick and Auvi-Q. Some parents say that they worry that the few moments needed to get familiar with a new injector could be costly in an emergency.
Pharmacists are racing to keep EpiPens on their shelves, scooping up fresh supply whenever they can. Ashley Seyfarth, the owner of New Mexico pharmacy Kare Drug, said she "plays the back-order game," ordering from her wholesaler as soon as a shipment comes in regardless of whether she has prescriptions that need immediate filling.
Steps taken by U.S. regulators in recent weeks suggest that they expect the deficit of EpiPen brand injectors to linger, meaning more headaches likely await parents of students returning to school next month. In June, the FDA said expiration dates for some devices would be extended by four months.
Mylan has been providing information about EpiPen production and distribution shortages to the FDA on a weekly basis, said agency spokesman Nathan Arnold. The FDA can't say when the shortage will end, he said.
"The FDA looks at drug shortages on a national scale," Arnold said. "There may be local shortages in any given area of the United States even when there are not national shortages."
Mylan shares declined as much as 4.7% on Wednesday, the largest intraday decline in more than a month. So far this year, the drugmaker's stock price has fallen by 32%.
The current problems finding EpiPens can be traced back to September 2017, when Pfizer Inc.'s Meridian Medical Technologies division, which makes them for Mylan, received a warning from the FDA after allegedly failing to investigate hundreds of complaints about faulty devices.
Pfizer spokeswoman Kim Bencker said the company is also frustrated by the unsteady supply and that EpiPens involve a "highly complex and technical" manufacturing process.
"Despite our significant efforts, we do anticipate further supply shortages over the coming months," Bencker said. "Product is routinely shipping, and we are committed to permanently resolving this availability issue as quickly as possible."
Mylan spokeswoman Lauren Kashtan said the company is sending shipments as soon as it receives the product from Meridian and encourages people to call customer relations for assistance in locating alternative pharmacies. The generic injector made by Mylan isn't offically in shortage, according to the FDA.
Pharmacists say that nailing down when they can get more EpiPens has been difficult. Carter High, owner of Best Value Rhome Pharmacy in Texas, said his wholesaler has pushed back the date when more injectors would be available several times.
"As a parent, I look at that and think, God I wish I could help them," High said. "I can't. There's nothing to give them because I just can't get it."
High said he has also had difficulty obtaining Mylan's generic EpiPens. At times, he said he gave patients epinephrine, the drug delivered by a shot from Mylan's device, the "old-school way," with a syringe. He said he tells patients to keep expired EpiPens because it's "better to have something than nothing."
In the meantime, brand-name EpiPen prescriptions have swooned. After peaking at more than 580,000 in August 2016, there were just 27,000 in May 2019, according to data compiled by Bloomberg Intelligence.
Going without an EpiPen can be dangerous for patients like Ashley Spencer, 29. She was eating a strawberry when she went into anaphylaxis on June 23. Her skin was bright red and itchy. Her throat was closing.
Spencer, who suffers from a rare autoimmune disease, didn't have an EpiPen. She'd been waiting for a refill for more than a week when her body developed the new allergy.
"I can't go a week and a half without it because my disease also can cause me to go into anaphylaxis at any time," Spencer said. EpiPens "are crucial to my life."
"As a parent, I look at that and think, God I wish I could help them...There's nothing to give them because I just can't get it."
Insurance companies have sometimes balked at paying for pricier alternatives. High, the Texas pharmacist, said wholesalers "have plenty of Auvi-Q, but at $5,000 a whack, I can't even get insurance to pay for that."
While some large pharmacy chains have struck agreements with EpiPen competitors to try to alleviate the shortage and reduce patients costs, others have struggled to get insurers to pay for alternatives.
"Though there are other things out there, we can't use them even if we can get our hands on them," said Seyfarth, the pharmacist in New Mexico.
Additionally, a new generic made by Teva Pharmaceutical Industries Ltd. has been difficult to track down, pharmacists say. "I've never actually seen Teva's product in the marketplace," said Hamilton, New Jersey, pharmacist Eklavya Lalwani.
In an earnings call in May, Teva Chief Executive Officer Kare Schultz said the company is "ramping up the volumes" and is distributing its injector to Anda Inc., a supplier the drugmaker owns. "Any pharmacy who needs EpiPen can just call Anda, and they will get it within 24 hours," Schultz said in May.
Teva spokeswoman Kelley Dougherty said the company has no backorders for the product, but both High and Lalwani said it was indicated as out of stock in Anda's ordering system on July 8.
Elsewhere, Sandoz, a division of Swiss drug giant Novartis, said on Tuesday that Symjepi epinephrine injections, previously only given in hospitals and clinics, will now be available at pharmacies.
Even when insurance covers another brand, some parents like Klaassen, in Boston, have trained their family and friends on Mylan's device and don't want to switch. Others such as Erin Malawer, who lives near Washington, switched her 14-year-old son to Auvi-Q but still tries to find at least one EpiPen, because she fears that his friends or teachers might not recognize an alternative device in an emergency.
"If you're looking for an EpiPen, blue and orange tube, and it's not there, you're wasting precious seconds that could save a life," Malawer said.