The Food and Drug Administration approved the first generic versions of Mylan’s EpiPen on Thursday, opening the door for a cheaper and possibly more widely available treatment for life-threatening allergic reactions.
In a released statement, the FDA said Teva Pharmaceuticals USA could market their version of the auto-injectors. These devices deliver the drug epinephrine into a person’s thigh to inhibit severe allergic reactions against potentially life-threatening allergens, such as peanuts or a bee sting.
These reactions include anaphylaxis, which can cause hives, constricted airways or a swollen tongue and throat that can make breathing difficult. It’s something one in 50 Americans have experienced, according to the FDA.
“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,” said FDA Commissioner Scott Gottlieb in a released statement.
Gottlieb, appointed by President Donald Trump last year, has said the administration wants to make lowering drug prices a priority, though he’s said recently prices may need to be increased for certain drugs in short supply.
In recent years, pharmaceutical company Mylan came under public outrage for how it priced its life-saving product. A decade ago, pharmacies paid $103 for a set of two auto-injectors filled with epinephrine. By 2016, that price rose to $608 for the same product — an increase of 400 percent. The Department of Health and Human Services reported in 2016 that the company overcharged taxpayers by as much as $1.27 billion for EpiPens over a 10-year period.
It’s not clear how much Teva will charge for its version of the EpiPen.
Congress launched an investigation into Mylan’s pricing of EpiPens amid reports that the company settled with the Department of Justice over allegations that Mylan overcharged Medicaid patients for EpiPens.
Alternatives to EpiPen already exist, but doctors most often prescribe EpiPen, CBS News reported in 2016.
Tonya Winders, president and chief executive officer of the Allergy and Asthma Network in Vienna, Virginia, praised the FDA’s decision to allow more generic epinephine autoinjectors.
“More options for patients and healthcare professionals will help ensure those who need access to epinephrine get it in a timely and more affordable fashion,” Winders said.
The decision advances generic competition in this market, said Holly Campbell, a spokesperson for PhRMA, the pharmaceutical industry’s lobbying group, in a statement.
“Innovator companies invest in pioneering research to bring new medicines and combination products to patients, and over time those medicines become available as lower-cost generic versions.”