Extending expiration dates on EpiPens is not as crazy as it sounds

As everyone with severe allergies—or everyone who loves anyone with severe allergies—freaks out over the ongoing EpiPen shortage, the Food and Drug Administration has taken an unusual step: It pushed back the expiration date for specific lots of auto-injectors marketed by Mylan. The dates will be extended by four months.

Here’s why that’s not as crazy as it sounds:

Drug expiration dates are somewhat arbitrary. While expiration dates are critical on things like warm tuna sandwiches, there is convincing evidence that many drugs last far past their so-called expiration dates, even as much as 30 years. The dates on drug labels aren’t when the drugs turn toxic, but rather the point where the FDA and drug companies can no longer guarantee their effectiveness, typically at two or three years.
Drug expiration dates are conservative by design. But drugs aren’t suddenly ineffective past their dates. As ProPublica reported, back in 2012, scientists stumbled on a trove of pharmaceuticals that were 30 to 40 years past their expiration dates. The study, published in the Archives of Internal Medicine, found that “a dozen of the 14 compounds were still as potent as they were when they were manufactured, some at almost 100% of their labeled concentrations.” This backs up an earlier study by the FDA itself, done at the behest of the military, which had a lot of drugs it didn’t want to throw out every few years.

That said, the FDA discourages people from using old drugs and it is the governing body. “Expiration dates should not be ignored,” FDA spokeswoman Theresa Eisenman told Fast Company in an email. “Expired medical products can be less effective due to a decrease in strength or pose potential safety risks due to changes in chemical composition. Once the expiration date has passed there is no guarantee that the medicine will be safe and effective. If your medicine has expired, do not use it.”

Even one of the authors of the 2012 study wouldn’t recommend using expired medication, claiming their study just looked at the “arbitrary way the dates are set.”

As for why the FDA was willing to extend the expiration date on EpiPens, the decision was not a precursor to a revised drug-expiration policy. “Mylan submitted data to the FDA to show that a specific lot of its EpiPen product remained stable, retaining its strength, quality, and purity for up to 24 months when stored according to its labeled storage conditions,” explained Eisenman. “The FDA reviewed this data and determined to exercise discretion to allow Mylan to extend the expiration date of specific lot numbers by four months beyond the labeled expiration date to mitigate a potential shortage of EpiPen.”