EpiPen Shortage Hits Back-to-School Season

By Joseph Walker

Parents are scrambling to find pharmacies carrying EpiPens for the new school year as regulators and the drug's manufacturer struggle to abate a continuing global shortage of the lifesaving devices.

EpiPens, the emergency epinephrine treatment for allergic reactions, have been in short supply since at least May, when the U.S. Food and Drug Administration first declared a shortage. Some pharmacies around the country have been unable to restock the medication for weeks at a time because of the shortages.

A rival epinephrine injector product, a generic version of Adrenaclick made by Amneal Pharmaceuticals Inc., is also in short supply, according to the FDA. That product is manufactured at a different Pfizer plant in Kansas, where production delays have caused shortages since the first quarter of the year, an Amneal spokesman said.

The scarcity is being felt more acutely now amid the back-to-school rush of August and September when demand for the devices is highest. For parents of children with food allergies, refilling EpiPen prescriptions, which are typically for sets of two in case the first injection doesn't work, has become part of the annual back-to-school ritual.

Julie Cook has been unable to fill EpiPen prescriptions for her two teenagers since the beginning of August and is relying on a single unexpired set if one of them has an allergic reaction. When she called a Walgreens near her Wheaton, Ill., home a few days ago, the pharmacist said they may not have more until September.

On the first day of school this week, Ms. Cook split the unexpired EpiPen set and gave one injector each to her children. As a backup, she also gave each an old, expired injector from among the dozen or so she keeps just in case.

"It's so frustrating," Ms. Cook said. "Why is this happening in August? What's going on? And what's going to happen in the future?"

EpiPens are sold by Mylan NV and manufactured at a Pfizer Inc.-owned plant in Brentwood, Mo. Pfizer has been unable to make enough EpiPens because it is changing its manufacturing processes in response to an FDA inspection last year that found several violations, including a failure to investigate serious complaints about product quality. In a statement, Pfizer said, "We are working tirelessly to increase production and expedite shipments as rapidly as possible."

Mylan referred questions about manufacturing delays to Pfizer. In a statement earlier this month, the company encouraged patients to call its customer service hotline for assistance in locating pharmacies with EpiPens in stock.

Rajiv Malik, Mylan's president, said on an earnings call with analysts earlier this month that "Pfizer supplies to Mylan are inconsistent and inadequate in meeting global demand." There are months where supply from Pfizer is good, and "then suddenly we get very erratic," and supply is 30% to 40% off expectations "because of the quality issues," Mr. Malik said, according to a transcript.

To help alleviate the effects of the shortage, the FDA on Tuesday extended the expiration date for certain EpiPen lots for an additional four months. The devices typically have a shelf life of 20 months, the agency said. The FDA has also been in touch with manufacturers of rival products to help ensure alternatives are available, the agency said.

Kaleo, the privately held maker of the Auvi-Q epinephrine injectors, has significantly increased manufacturing capacity to help meet demand in the U.S. and Canada due to the EpiPen shortage, said Kaleo CEO Spencer Williamson in an interview. Some 40% of all epinephrine injectors are purchased during the back-to-school season, he said.

However some patients have said they are reluctant to use Auvi-Q because it isn't covered under their insurance or because it has a different mechanism that they and their children aren't used to.

Patient access to EpiPens has been a controversial issue since the summer of 2016, when parents looking to buy the devices for their school-age children complained they had to pay hundreds of dollars out of pocket to meet insurance deductibles. Congress began scrutinizing Mylan for raising the list price of EpiPen 548% over several years to about $608 for a set of two. Mylan later began selling its own generic version of EpiPen for $300.

Earlier this month, the FDA approved the first generic EpiPen from a rival, which the agency said was part of an effort to inject more competition into the pharmaceutical industry and bring down prices. But Teva Pharmaceutical Industries Ltd., which will market the generic version in the U.S., said the product would be launched in "coming months." Antares Pharma Inc., which is manufacturing the injection device for Teva's generic, said the delay wasn't due to manufacturing constraints on its part and that it has already shipped $22 million of product to Teva.

Meanwhile, Mylan issued a nationwide recall last year of certain EpiPen lots because of a potential manufacturing defect that could cause the devices to fail to activate. In a letter to Pfizer last year, the FDA admonished the company for "not thoroughly investigat[ing]" hundreds of complaints it received, stating that "EpiPen products failed to operate during life-threatening emergencies, including some situations in which patients subsequently died."

Pfizer said in a statement that "there is no information to show that there was any causal connection between complaints of product failure and any patient deaths."

Rosvold Pharmacy in Cinnaminson, N.J., hasn't received an EpiPen shipment since July 19, said owner Thomas E. Stehr. The pharmacy tries to order more every day, but it is still on back-order, he said. "We have a pretty good school-age population here," and "the parents start freaking out" when they can't get EpiPens, Mr. Stehr said.

Wegmans Food Markets Inc., an East Coast supermarket chain, said its pharmacies' supply of EpiPens has been spotty since April, and some of its stores have extremely limited quantities. A significant share of EpiPen prescriptions are filled between July and September, according to a Wegmans spokeswoman. To meet demand, the company will move product between stores or refer patients to another location, she said.

Tory Palenscar tried in early August to fill EpiPen prescriptions for her 7-year-old daughter, who suffers from severe food allergies. Her daughter's school wants her to have four sets.

But there were no EpiPens at any pharmacy near Ms. Palenscar's home in Beaumont, Calif. "I started panicking," she said. Finally, Ms. Palenscar found a pharmacy 30 minutes away in San Bernardino that agreed to hold one set for her, but she is still waiting to buy more. She used a voucher from Mylan to cover the prescription's $170 copay, she said.

She and her husband are keeping the new EpiPen set in an emergency bag. Ms. Palenscar also obtained two sets of Auvi-Q, which Kaleo provided to her free of charge because her insurance policy doesn't cover the product. She has given the Auvi-Q injectors to her daughter's school, along with two expired EpiPen sets.

"There's been so many recalls and overcharging. It's one thing after another, and it feels like we're being taken advantage of and played with," Ms. Palenscar said. "This is my daughter's life."

Write to Joseph Walker at joseph.walker@wsj.com

(END) Dow Jones Newswires

August 25, 2018 09:14 ET (13:14 GMT)

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