Mylan chief executive Heather Bresch said one thing at a contentious hearing last week that could quell criticism from people with life-threatening allergies: Mylan will soon push to extend the shelf life for EpiPen.

EpiPens currently expire 18 months after their date of manufacture. Facing outrage from patients and politicians for the drug’s rapidly rising price, Bresch said the company hopes to extend this to a minimum of 24 months.

To make the change, Mylan will need to convince federal regulators that its data demonstrates that a new EpiPen formulation can remain effective for months longer.

“We hope, within the next 12 months, we will have approved a new formulation that will extend the shelf life,” Bresch said during Thursday’s hearing.

An extension would increase the time between refills, helping to address a common complaint among patients and parents who have to toss out unused EpiPens annually and buy new ones. The devices cost more than $600 for a pack of two. (There is a common misconception that Epi- Pen’s shelf life is a year because time elapses between the manufacturing of the drug and when people pick up their prescriptions.)

This would not be the first time EpiPen’s time frame for expiration was altered. In 2002, the product’s shelf life was 27 months, but a formulation change by then-owner Meridian Medical Technologies required a shorter period, according to the Food and Drug Administration. Initially, the approval was for 20 months, but subsequent data supported 19 months. The company decided to use 18 months, she said.

EpiPen’s shelf life has been limited by the chemistry of the drug it contains. Epinephrine is notoriously finicky. If exposed to light, heat or air, it can degrade.

Only subscribers are eligible to post comments. Please subscribe or login first for digital access. Here’s why.

Use the form below to reset your password. When you've submitted your account email, we will send an email with a reset code.