How Federal Regulations Hiked EpiPen Prices
From the FDA’s perspective, an epinephrine auto-injector is a combination product; composed of both a drug and a medical device. The principal method of action of the combination product determines whether the FDA’s Center for Drug Evaluation and Research or the FDA’s Center for Devices and Radiological Health takes the lead on the approval process.
Since the method of action is epinephrine, an epinephrine auto-injector is considered a drug and must go through a new drug application (NDA) process. Once the patent expires, competing drug makers can, at least in theory, apply for an abbreviated new drug approval (ANDA) for a generic drug. Generic epinephrine is made by several firms and sold inexpensively in ampules. Yet, the FDA requires each new epinephrine auto-injector to be approved as if it were a new drug.
Even if firms were allowed to apply for the right to sell a generic using the older EpiPen design, the backlog of ANDAs awaiting the FDA’s approval number nearly 4,000. Approving a competing product could take several years — even if the FDA were willing to approve a generic based on the older design, which is unlikely.