The Food and Drug Administration has approved a cheaper generic version of the allergy drug EpiPen, which was the subject of intense public scrutiny a few years ago due to its $600 price tag for a two-pack.
The agency said on Thursday that the move was part of an effort to speed up approval of more complex generic products in order to lower prices.
“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,” FDA Commissioner Scott Gottlieb said in a statement.
[Also read: FDA broke monthly generic drug approval record in July]
The EpiPen is a combination of a medical device and a drug that delivers an emergency dose of epinephrine to deal with a life-threatening allergic reaction.
Mylan ignited public outcry back in 2016 after the price of a two-pack of EpiPen increased to $608 in 2016 compared to $103 in 2009.
Mylan was able to raise the price due to a lack of competition, such as a generic competitor. Mylan, whose CEO is West Virginia Sen. Joe Manchin’s daughter Heather Bresch, had a much larger market share than both of its brand-name competitors, contributing in part to the price hikes.
Mylan responded to the price furor by making an “authorized generic” of EpiPen, but left in place the original’s high price.
“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,” FDA said. “The labeling or packaging is, however, changed to remove the brand name or other trade dress. In some cases, a company may choose to sell an authorized generic at a lower cost than the brand-name drug product.”
But Teva now has approval to make a generic EpiPen. Teva is a different company that could offer a lower-priced version.
