The Myth of Drug Expiration Dates

There’s not necessarily anything scientific or magical about the dates printed on medications

BY NAVPREET DHILLON

hose expiration dates stamped on everything from a gallon of milk to a bottle of acetaminophen don’t mean what you probably think. Food doesn’t suddenly become unsafe and medicine doesn’t magically lose its potency at noon on a certain preordained day.

But that doesn’t stop hospitals, nursing homes, businesses and households—just about every institution— from wasting billions of dollars every year by throwing out food and drugs that might still be good.

See, it’s more subtle than being OK one day and not OK the next. Expiration dates represent the latest date when the manufacturer guarantees a drug’s safety and full potency. While the law requires drug makers to provide expiration dates, setting them is more or less on the honor system.

The U.S. Food and Drug Administration (FDA) isn’t responsible for verifying expiration dates when approving a drug. That lack of oversight leads critics to charge pharma companies with setting the dates with an eye toward enticing buyers to throw out and replace medicine that might still be perfectly good.

Whether the motivation is corporate profit or just an abundance of caution, it’s clear that at least some classes of drugs can last much longer than the expiration dates suggest.

ARE OLD EPIPENS SAFE?

EpiPens—a brand name for auto-injectable devices that deliver epinephrine to counteract an allergic reaction— provide a good example of a product without firm rules for expiration dates, says Dr. Lee Cantrell, director of California Poison Control.

Cantrell led a study that found expired EpiPens contained at least 84% of the original dose of epinephrine 50 months after the expiration date. Given the FDA allows 90% to 110% variability in doses, EpiPens could last at least 29 months after their expiration date with 90% potency, he notes.

Every EpiPen his team tested would deliver the dose needed to prevent fatal anaphylactic shock, including the oldest one that was 50 months past the expiration date. The dose ranges from 0.2 to 0.5 milligrams for adults, and the maximum for children is 0.3 milligrams.

“I wondered if the expired EpiPens contained enough viable medication to potentially be beneficial in the case of an emergency,” Cantrell said. “And the majority of them had the potency that we used.”

NEARLY ALL ALBUTEROL PRODUCTS RETAINED MORE THAN 90% OF THEIR LISTED STRENGTH FOR MORE THAN 15 YEARS POST-EXPIRATION.

Still, he doesn’t recommend routinely using expired EpiPens. But in a pinch, one within the 50-month time limit could save a life.

But the drug’s longer-than-anticipated lifespan isn’t the only reason it’s attracting attention.

CONGRESSIONAL HEARINGS

EpiPens manufacturer Viatris (VTRS) and the corporate entitites that preceded it have been under fire for years for the way they’ve handled EpiPen pricing and how they have allegedly dictated expiration dates to increase revenue.

The trouble began even before 2020, when Pfizer (PFE) spun off its Upjohn Business and combined it with Mylan to create Viatris.

As early as 2016, Congress hauled Mylan management into a hearing for a dressing-down by skeptics that included U.S. Rep. Gerald Connolly, R-Va.

“Because you have such a stranglehold on the market, you could do what you want in terms of pricing—and you have,” Connolly said to Heather Bresch, who was then Mylan CEO.

The Mylan-Viatris lineage had endured for 30 years, remaining the sole source of epinephrine up until the FDA approved AuviQ, a generic, in 2012. Even after losing its exclusive right to make the drug, Mylan was still clinging to a 94% market share in 2016.

EPIPEN PRICE SKYROCKETS

Mylan raised the price of a pack of two EpiPens from about $100 in 2007 to $608 in 2016, even though the cost of labor and materials had not risen commensurately.

Besides, EpiPens expire 18 months after they’re made, causing families to suffer financial hardships or risk fatal anaphylactic shock, observers note.

But those policies caught up with the company.

In 2017, Mylan paid $465 million to settle a lawsuit brought by the Department of Justice, according to Fierce Pharma, a watchdog website for the pharma industry.

In 2022, Viatris agreed to pay a $264 million settlement class-action antitrust lawsuit filed by consumers and insurers, The New York Times reported.

It was the rapidly rising cost of EpiPens that led Cantrell to begin his study, but it wasn’t his first crack at tackling expiration dates.

STUDYING EXPIRATION

In 2012, one of Cantrell’s friends found 25- to 40-year-old medications in the back of a closet in a pharmacy he owned.

“I’m always really skeptical about the dating of medications, and we analyzed them and found the majority of them retained their full potency,” Cantrell noted.

Twelve of the 14 compounds that Cantrell studied were within the 90% to 110% efficacy concentration the FDA mandates, notably acetaminophen (Tylenol), hydrocodone (Vicodin) and codeine.

Granted, the medications were stored in a pharmacy under nearly ideal conditions, which would likely extend their useful lifespan. But even in a less than perfect environment, drugs tend to last much longer than expiration dates dictate, Cantrell maintains.

A similar study of the post-expiration strength of the asthma medications albuterol and montelukast led by Dr. Raman Kutty of White River Health System also demonstrated that “expiration date” is a misnomer.

“Often, the expiration date is interpreted as the date beyond which the medication is no longer effective.” Kutty wrote in a study published in 2022 by Heliyon, a research journal.

“It is important to note,” the paper says, “that the expiration date of a medication is determined by the manufacturer based on the stability of the drug under specific storage conditions, and it is not intended to indicate the exact point at which a drug becomes ineffective or unsafe.”

Nearly all albuterol products “retained more than 90% of their listed strength for more than 15 years post-expiration,” Kutty’s study indicates.

DOOMSDAY PREPPERS

While the FDA doesn’t regularly test expired drugs, it runs the Shelf Life Extension Program (SLEP) for the Strategic National Stockpile, the government’s emergency repository of critical medicine.

That’s how the FDA found 88% of 122 commonly used drugs retain efficacy for longer than a year after said expiration date, Cantrell said. “With an average extension of 66 months and a maximum extension of 278 months,” he noted.

Every dollar SLEP spends on research saves the government $94 because medications can stay in the stockpile longer, according to a National Library of Medicine article by Brooke Courtney, a senior FDA regulatory counsel.

MANUFACTURERS DETERMINE THE EXPIRATION DATES OF THEIR DRUGS.

So, if the FDA finds through SLEP that Americans could spend significantly less on medications, why aren’t manufacturers compelled to extend the expiration dates?

As the House Oversight Committee emphasized back in 2016, manufacturers follow the money. While Mylan paid over a billion dollars in settlements for its EpiPen price-gouging, it hasn’t extended EpiPens’ expiration dates and a pack of two EpiPens costs $690 as of December 2022.”