Morning Briefing
Summaries of health policy coverage from major news organizations
First Generic Version Of EpiPen Injector Approved By FDA And Could Lower Cost Of Drug
Stat: FDA Approved The First-Ever Generic Version Of EpiPen
The Food and Drug Administration approved the first-ever generic version of EpiPen Thursday — a move the agency says could help lower costs for the drug, which can carry a price tag of more than $600. It isn’t clear how much the new version, which will be sold by Teva, will cost. But it may be a lower-cost option for individuals with allergies, who need to keep this lifesaving medicine with them at all times. Right now, a two-pack of EpiPen, marketed by Mylan, currently lists for $608.61. Mylan also makes its own “authorized generic” version, which it sells for $300 per pair. (Swetlitz, 8/16)
The Wall Street Journal: FDA Approves Teva’s Generic Version Of EpiPen Injector
The product, whose brand-name version is manufactured by Mylan NV, touched off a furor two years ago over its price increases of 548% over about a decade. ... Mylan introduced its own half-priced generic version of the drug in 2016. (Burton, 8/16)
NPR: FDA Approves New Generic Version Of The EpiPen For Allergic Reactions
The FDA says the approval of the new products should help with both cost and availability. "Today's 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 advance access to lower cost, safe and effective generic alternatives," FDA Commissioner Scott Gottlieb said in a statement announcing the approval. (Stein, 8/16)
The Associated Press: US Approves New Generic Competitor To EpiPen
EpiPen injections are stocked by schools and parents nationwide to treat children with severe allergies. They are used in emergencies to stop potentially fatal allergic reactions to insect bites and stings and foods like nuts and eggs. EpiPen maker Mylan has dominated the $1 billion market for the shots for two decades. Several other companies sell competing shots containing the drug epinephrine, but they aren’t heavily marketed or prescribed by doctors. (Perrone, 8/16)
The Washington Post: FDA Approves First Generic Version Of EpiPen
The approval comes right before the back-to-school season, when sales of EpiPen typically spike as parents stock up on injectors for school or replace expired ones, and people have reported difficulty filling EpiPen prescriptions. There has been “limited availability of EpiPen in certain areas in the U.S., including both pharmacy-level supply disruptions and a manufacturer issue,” according to FDA spokeswoman Theresa Eisenman. (Johnson and McGinley, 8/16)
PBS NewsHour: FDA Approves First Generic Rival To 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. (Santhanam, 8/16)
The Hill: FDA Approves First Generic Version Of EpiPen
Teva did not respond to questions about how much its generic version will cost, or when it will become available. “We’re applying our full resources to this important launch in the coming months and eager to begin supplying the market,” Teva said in a statement. (Weixel, 8/16)
