Mylan CEO Heather Bresch's recent announcement that Mylan is looking to extend the shelf life of the EpiPen could help make costs more manageable for food allergy sufferers, who must replace the expensive devices nearly every year.
Bresch said Wednesday during a tense hearing of the House Committee on Government Oversight and Reform that the company plans to submit a request to the Food and Drug Administration “within days,” and has been working for "a couple of years" on extending the shelf life of the EpiPen from 18 months to 24 months.
Extending the shelf life of the EpiPen may take significant research and development because epinephrine, the drug inside the EpiPen, is known for having a short shelf life and being highly susceptible to heat and light.
Most consumers replace their EpiPens every year, though the FDA-approved shelf life of the device is 18 months. It's likely that many patients aren't receiving them at the beginning of their shelf life; patients on a number of online forums report that pharmacies have offered them products that are marked to expire in less than ten months.
Patients say it's a waste of money replacing the device every year, even if it's not used. Even though it's possible the EpiPen could last beyond its expiration date, patients can't risk having an ineffective dose when it comes to the life-or-death situation of anaphylactic shock. So most patients won't hold onto their EpiPen too far past expiration. The devices can cost as much as $608, the list price, though the price paid by patients varies widely based on insurance and discount cards.
A number of studies have suggested that that the EpiPen's shelf life could be extended, but until recently Mylan hadn't publicly revealed plans to request a formal change.
In order to successfully request an expiration date change, Mylan has to gather enough data to convince the FDA that the product meets the agency's specifications for drug stability through the end of the requested timeframe. But if the company's data is solid, that process is pretty straightforward and objective, said David Rosen, head of the FDA practice group at law firm Foley & Lardner.
“It either meets specifications or it doesn't,” Rosen said. “If it meets specifications…they will get approval to extend the expiration date.”
The request is called a manufacturing supplement, which is added to the EpiPen's new drug application. The FDA says its goal is to review 90% of those requests within four months, and most requests generally are approved or declined within four to six months, said Rosen, a former FDA official and pharmacist.
There have been 28 supplements approved for the adult EpiPen application since it was approved in 1987, including an expiration date change in 2002, according to an FDA database. It's not clear what the expiration date was before 2002, and Mylan did not immediately respond to a request for that information or other comment on this article.
It's unclear exactly what changes Mylan or prior distributor Merck KGaA have made to the product that might extend shelf life, because some previous documents are not available on the FDA's site and documentation makes it hard to tell how the device has changed. Bresch said the company hopes to have a "new formulation" approved in the next 12 months.
Rosen said the company may have changed its manufacturing process or it may be using some kind of chemical stabilizer in its epinephrine solution to prevent oxidation and lower its sensitivity to heat. Any effort to extend the shelf life of the EpiPen would take significant time and money because of the characteristics of epinephrine, he said.
Rosen acknowledged the questionable timing of Bresch's announcement amid public outrage, but expressed doubt as to whether extending the shelf life by six months would have a significant effect on patient costs, because patients often don't get their prescriptions filled on time anyway, he said. Patients also need to consider that if they don't store the product in a cool, dark place, it could go bad even before the expiration date, he noted.
When asked whether Mylan could justify raising the price of the product if it's able to successfully extend the shelf life, Rosen said it's possible but highly unlikely given public backlash. “I think the heat is on them, and they'll probably be pretty conservative over the next few years,” he said.