A generic competitor to the EpiPen won’t cost any less than the version already on the market, despite the Trump administration touting it as a cheaper alternative.
Teva Pharmaceuticals on Tuesday said its drug is now available in limited quantities in the United States, for a wholesale cost of $300. The drug already on the market from original manufacturer Mylan also costs $300.
In a statement Tuesday, Food and Drug Administration (FDA) Commissioner Scott Gottlieb said the generic epinephrine injector is still less expensive than the branded version, but said the agency has no control over how private companies set their prices.
"We cannot control commercial decisions on pricing," Gottlieb said. "Importantly, we have found that having three or more generic competitors brings prices down more sharply than with only one or two generic competitors."
Gottlieb added the agency will continue to focus on bringing more generic versions of complex drugs to the market.
The FDA approved generic versions of both the EpiPen and the lower dose EpiPen Jr. in August. Gottlieb touted the approvals as part of an “overarching effort to remove barriers” to access “critically important” drugs.
“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,” Gottlieb said at the time.
Gottlieb has said approving more generic drugs will help put pressure on manufacturers to lower the costs of their drugs.
The EpiPen is meant to inject epinephrine into patients to stop a potentially fatal allergic reaction. Consumers and lawmakers have been clamoring for a generic version of the EpiPen since Mylan drastically hiked the price more than 400 percent in less than a decade.
The price has risen from less than $100 in 2007 for a pack of two injectors to just more than $600. As a result of the outcry, Mylan began selling an “authorized generic” for $300. An authorized generic is essentially the same product as the brand-name drug, just marketed as a generic.
Lawmakers have often cited the price hike as a key example of skyrocketing drug costs, and CEO Heather Bresch was grilled for hours during a 2016 Senate hearing.
The company has faced little competition from other manufacturers and has benefited from a virtual monopoly on the market. However, Mylan has been experiencing a shortage of its EpiPens since May.
Courtesy of: https://www.medpagetoday.com/publichealthpolicy/generalprofessionalissues/76551