MARY REICHARD, HOST: It’s Tuesday, the 28th of August, 2018.
Glad to have you along for today’s edition of The World and Everything in It. Good morning, I’m Mary Reichard.
NICK EICHER, HOST: And I’m Nick Eicher. First up today, a shortage of EpiPens.
That’s causing some additional back-to-school anxiety for parents of kids with dangerous allergies.
About 1 in 13 children has a food allergy. And many of them rely on EpiPens. These, as the name implies, are pen-shaped injection devices that deliver epinephrine to treat potentially fatal reactions.
REICHARD: EpiPens release artificial epinephrine into the bloodstream, opening airways and stimulating the heart to beat faster. That reverses the effects of an allergic reaction.
Many parents fill their children’s prescriptions right before they head back to school, but this year parents are having a hard time getting that done. World Radio’s Sarah Schweinsberg explains.
SARAH SCHWEINSBERG, REPORTER: Andrea Oswald discovered her daughter Hayden’s food allergy when she was just a baby.
OSWALD: I had given her a, like a Girl Scout peanut butter cookie to just munch on or whatever. And she immediately scraped at her tongue. I noticed she had red marks around her mouth.
After two more encounters with peanut butter produced hives soon after, Oswald took Hayden to the doctor and confirmed she had a peanut allergy.
OSWALD: They did the whole allergy test on her back and she was fairly allergic. But, but no tongue swelling or anaphylaxis or trouble breathing or anything.
Still, the severity of an allergic reaction is unpredictable, so doctors prescribed pharmaceutical company Mylan’s EpiPen Junior for Hayden.
Pharmaceutical companies advise patients to replace EpiPens once a year since they can’t guarantee the epinephrine will work after 12 months. So before Hayden started second grade last week, Andrea Oswald refilled her annual prescription at a local pharmacy.
Oswald didn’t have trouble getting her daughter’s EpiPens, but other parents are struggling to get the potentially life-saving device.
In May, the Food and Drug Administration added epinephrine auto-injectors to its drug shortage list. Nearly four months later, they’re still there. Jennifer Madsen leads federal advocacy at Food Allergy Research and Education or FARE. She says the shortage first affected patients in the United Kingdom and Canada.
MADSEN: We put together a survey to try to ascertain how much impact this was having in the U.S. and within the span of about a week and a half, we received reports of over 400 cases in 45 states where individuals were reporting that they were either unable to fill or only partially able to fill a prescription for an EpiPen.
What’s behind the shortage? Only three companies sell auto-injectors: Mylan, Amneal Pharmaceuticals, and Kaleo Incorporated. Patent protections have prevented other manufacturers from entering the market, creating a near monopoly.
And now, Mylan and Amneal are both having manufacturing problems.
Mylan’s brand-name injector makes up 10 percent of the market, and its generic auto-injector 60 percent. Amneal makes up 30 percent, with a product called Adrenaclick.
Mylan’s manufacturing issues started in 20-17 when the F-D-A cited manufacturing violations at Mylan’s only U-S EpiPen plant. That plant is run by Pfizer Pharmaceutical. Amneal has also reported manufacturing problems at its Pfizer plant as a result of compliance issues. Pfizer cites issues with third-party suppliers.
Last week, Pfizer Chief Medical Officer, Dr. Freda Lewis-Hall said the company is working hard to address the problems.
LEWIS-HALL: We want you to know that Pfizer as the manufacturer of EpiPen is working around the clock to get back on track to full supply as quickly and as safely as possible.
Kevin Linderman is a supply chain and operations professor at the University of Minnesota. He says it’s especially difficult for pharmaceutical companies to keep production up when they encounter manufacturing issues.
LINDERMAN: When you’re in the medical area, and you’ve got the FDA, they’ll approve a process, and then you need to make sure that you’re maintaining that process to the exact standards that was approved by the FDA. So if you’re having a problem filling an FDA approved process, you just can’t shift production to another facility like an auto manufacturer could potentially do that.
FARE’s Jennifer Madsen says the FDA is pursuing several strategies to cope with the shortage. Last week the agency approved a new EpiPen generic made by Teva Pharmaceuticals.
MADSEN: And so what that means is if you have a prescription from your doctor for an EpiPen and you go to the pharmacy counter, the pharmacists can substitute and give you the Teva product.
But that product won’t hit shelves for at least a few weeks. The F-D-A and Mylan also announced they are extending certain EpiPen expiration dates by four months to alleviate shortages.
MADSEN: It’s better to have an expired product on hand than to not have anything at all.
But that offers little comfort to parents like Andrea Oswald who trust EpiPens and other auto-injectors to reverse a potentially fatal allergic reaction.
OSWALD: I just don’t feel good about not having something that’s current and you know, it’s not something you want to chance.
Mylan says it hopes to return supplies to normal levels by the end of this year.
Reporting for WORLD Radio, I’m Sarah Schweinsberg.