Several studies have suggested that most epinephrine auto-injectors remain effective long after the expiration dates printed on the devices.
Epinephrine auto-injectors use and cost
An epinephrine auto-injector is a vital device that prevents severe anaphylactic (allergic) shock.
Mylan, the producer of EpiPen, controlled almost 90% of the U.S. market until August of 2018. Due to its large market share, Mylan has dictated the price of this essential medication for decades. The cost of EpiPen has jumped by almost 600% since 1989.
(I understand that the cost of developing the delivery pen will add to the price of this medication but even this, can’t justify a 600% jump in the selling price.)
Lately, the cost of this medication has drastically increased because of the heightening manufacturing costs, shortage of the product, or both.
Consequently, many patients cannot afford this medication because of the exponential increases in price.
Considering this, you might think that epinephrine, the main component of this auto-injector, is a fancy and advanced medication that Mylan, and other companies, had to invest millions of dollars to develop.
What’s the real story?
Epinephrine was discovered in the 1800s, and first synthesized in 1904.
Therefore, this medication has been around for over a century, making it even more astonishing that it bears the price tag it has today.
On the other hand, patients at risk for a severe allergic reaction have no choice other than paying these high prices and riding out the increasing cost. Sadly, even the prices of recently available generic epinephrine injections are too high for the average American.
In addition to unjustifiably high prices pushed by pharmaceutical companies, and shortages of the product itself, patients have to face another outrageous development–compressed shelf-life.
Epinephrine (EpiPen) expiration date
Several studies have concluded that epinephrine auto-injectors are still effective months after their expiration date. For instance, in one study, a total of 46 epinephrine auto-injectors were collected from various brands. The time between the labeled expiration date and the testing of the injectors were, in most cases, about 24 months. Approximately 80% of these products still retained their effectivity.
It is no secret that millions of people have serious concerns about rising drug prices. Most individuals undergo financial hardship in order to afford these life-saving medications. I frequently hear stories from my patients that often worry me. Although I do not agree with the pricing politics of medications in the United States, I can understand that these companies are looking after share-holders and opportunities to make more money.
I feel that the FDA must function in a different way. The FDA’s share-holders should be the everyday residents of this country, including helpless children, and seniors on fixed incomes. Although the FDA has extended the expiration dates of a few epinephrine auto-injectors in August 2018. However, the four month extension is not enough.
Setting an extremely short shelf-life for a medication isn’t a matter related exclusively to epinephrine auto-injectors. Patients with insulin-dependent diabetes face the same challenges. I frequently encounter patients each week who cannot afford their insulin and are afraid to use their insulin because they can’t afford the next insulin pen.
The FDA must act
The FDA needs to do its part and contribute to the fight against increasing drug prices. Extending the expiration date of medications, especially the most expensive injections, can reduce the demand for these medications and help consumers save some money. Understandably, to establish the most accurate expiration dates, we must have high quality, extensive studies.
But today, we have enough data to support a greater extension for epinephrine and Epipen auto-injector usage.
We must come together and demand more action from the FDA. In fact, there are thousands of people who can’t afford their next life-saving epinephrine auto-injector and they need our society’s attention right now.
Clearly, I don’t recommend to ignore the expiration dates on the medication packaging without the FDA approval. But we need to encourage the FDA to do a better job in guiding the public in a timely manner.