The Tools That Help Stabilize EpiPen Shortage

After a year filled with public outcry over pricing and drug shortages, the FDA and Mylan are taking steps to increase patient access to epinephrine auto-injectors.

Mylan’s manufacturing partner, Meridian Medical Technologies (a subsidiary of Pfizer), continues to experience interruptions in the production of EpiPen and EpiPen Jr Auto-Injectors, according to a statement from Mylan. The company says it is “actively exploring several options” to help fix the supply problem, adding that its priority is to ensure patients with a life-threatening allergy have access to EpiPens.

Related article: Are EpiPens Still Good After Their Expiration Date? 

Mylan is promising to expedite shipments from Pfizer and to maintain closer contact with it and authorities about the status of EpiPen shipments.

The FDA, meanwhile, extended the expiration date of specific lots of 0.3 mg EpiPen products marketed by Mylan by four months beyond the labeled expiration date.

“FDA continues to work closely with Mylan on EpiPen production and supply, and also has been in contact with the other manufacturers of epinephrine auto-injectors, including Adrenaclick and Auvi-Q, regarding their supply as the school year begins since this is historically accompanied by increased product demand,” the agency said in a statement.

Generic Approved

The FDA made another big move late last week, approving the first generic versions of EpiPen and EpiPen Jr. Teva gained approval to market its generic epinephrine auto-injector in 0.3 mg and 0.15 mg strengths.

“Having more than one source of product for an emergency situation remains important in the U.S. market given the history of shortages as well as price,” says Randy Vogenberg, PhD, principal, Institute for Integrated Healthcare and chairperson of the Employer-Provider Interface Council.

While Teva did not reveal the cost of the generic EpiPen or when it will be available, in a statement the pharmaceutical manufacturer said it is applying its full resources to this important launch in the coming months and is eager to begin supplying the market.

“I think watching the cost of the generic as it becomes available will be more important and interesting, even more so, if it becomes available during shortage conditions,” says Nicholas W. Carris, PharmD, assistant professor, University of South Florida College of Pharmacy and Morsani College of Medicine.

FDA Commissioner Scott Gottlieb, MD, in a statement said the approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the U.S. is “part of our longstanding commitment” to safe, low-cost generic options. “This approval means patients living with severe allergies who require constant access to life-saving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages,” he added.

The FDA also said there are “authorized generic” versions of EpiPen and Adrenaclick, which are marketed without the brand names. An authorized generic is made under the brand name’s existing new drug application using the same formulation, process, and manufacturing facilities that are used by the brand name manufacturer.

Related article: Why Health Systems Are Making Their Own Generics

“Families and healthcare entities have been held hostage to product shortages in many critical care conditions, so these FDA efforts are welcome,” says Vogenberg. “Allowing competition to occur should help to further lower product prices at the patient level along with purchasers of care through commercial plans and CMS.”