This week, the FDA issued an alert that the EpiPen, a brand name epinephrine injection that should help someone having a serious allergic reaction, might not work properly. The problems include delayed injection, failure to inject, and difficulty removing the product from its container to commence an injection. If this drug fails to work on a patient who is in anaphylactic shock, the result can be death. In fact, such product failures were reported to have killed seven people in 2017 and led to 35 hospitalizations.
Warnings about bad drugs or medical products are often associated with imports, such as from India or China – or buying drugs online. But here we have a homegrown problem, which we actually export.
A few years back, in 2016, the biggest complaint about the EpiPen was its cost. That’s because drug company Mylan increased the price from about $60 to $600 over the course of about ten years. I published a Letter to the Editor in the New York Times noting how much cheaper the EpiPen is in Canada. A few days before my letter, I remember Consumer Reports warning its readers not to buy it from Canada because of safety concerns related to illegitimate online pharmacies: “Don’t Order EpiPens from Canada.” There are rogue online pharmacies that cannot be trusted, but licensed pharmacies in Canada, including those operated by or working with PharmacyChecker-accredited online pharmacies were selling the same EpiPens as the ones sold in the U.S. The far greater risk at that time was the safety of the product itself, as indicated by the seven reported deaths in 2017.
The FDA’s alert describes the situation and the ways in which the EpiPen sometimes doesn’t work. It offers ideas on how to check the product to see if there are problems. The FDA recommends that patients, caregivers and health professionals review the instructions on how to use the products and to practice with the trainer pen that comes with the product. The agency also instructs pharmacists to “inspect the products before dispensing them to patients to ensure quick access to the auto-injector and should not dispense any product which does not easily slide out of its carrier tube or has a raised blue safety release.”
EpiPen is an American-made drug, which is both sold here and exported to other countries, including to Canada. While drug company Mylan is the authorized marketer of the EpiPen in the U.S., drug giant Pfizer is the manufacturer via its subsidiary Meridian Technologies. This recent FDA alert should not come as a surprise. In 2017, Meridian was cited for cGMP (current good manufacturing practices) violations, when the FDA noted that the company still hadn’t fixed problems identified by the agency as far back as 2014.
To hammer home the point about exporting the problem: in 2018, Canada complained to Mylan about shortages of EpiPen. The headline in Reuters was “Canada seeks U.S. help to solve EpiPen shortage.” Due to manufacturing problems, Mylan was reporting shortages – but those shortages didn’t seem to apply to the U.S. This reporting by Reuters may explain why:
“The U.S. market is the most lucrative for EpiPen, where a two-pack of the generic injectors retails for $300. In Canada, a single EpiPen can be bought for $100, while the UK National Health Service price for a single dose is closer to $38.”
Epipen is made for all three countries is in Saint Louis, MO. What’s interesting, if not ironic, is that the same safety problems have not been reported in Canada or the UK as found in the U.S.
As of the summer 2019, Pfizer and Mylan appear to be looking for a change by having a new drug company manufacture Epipen as part of a merger between Mylan and drug company Upjohn. Let’s hope they get it right.
