1. Aschenbrenner, Diane S. MS, RN


* The Food and Drug Administration has granted Teva Pharmaceuticals approval to market the first generic version of the EpiPen.


* Some of the controversies surrounding approval of this generic product are described below. Alternatives to the EpiPen are also highlighted.



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The Food and Drug Administration (FDA) has approved the first generic version of the EpiPen and EpiPen Jr, epinephrine autoinjectors for the emergency treatment of allergic reactions. The generic products will be manufactured by Teva Pharmaceuticals USA. The adult version contains 0.3 mg of epinephrine and the pediatric version contains 0.15 mg and can be used for children weighing at least 33 pounds. The company has not yet announced the cost, although it is expected to be lower than that of brand-name EpiPen.


The FDA's approval of this generic product follows the controversy surrounding EpiPen pricing, which steadily increased after the drug was purchased by Mylan in 2007. At that time, EpiPen sold for $100 for a pack of two pens. By 2016, the price had risen to $609. In September 2016, public outcry over the price hike resulted in a Congressional hearing, during which Douglas C. Throckmorton, MD, deputy director for regulatory programs in the FDA's Center for Drug Evaluation and Research, emphasized that the FDA lacks any regulatory authority to control drug prices and stated that the agency recognized "that when more than one version of a drug, especially a generic version, is approved, it can improve marketplace competition and help to provide additional options for consumers. With this role in mind,[horizontal ellipsis] FDA is working hard to support the timely, scientific, and efficient development of new epinephrine auto-injector products." (For Throckmorton's entire statement, go to In a January 2017 interview with CBS This Morning, Mylan chief executive officer Heather Bresch suggested that the company had increased the product's price in part to offset the cost of donating pens to schools and providing education to physicians and legislatures around the country.


Previously, the FDA had been criticized for taking so long to bring generics to market, but its process has improved over the years. It used to take almost four years to approve generic submissions; currently it takes less than 15 months. According to the FDA, delays in the approval of generics are exacerbated by two factors. The first is citizen petitions filed with the FDA urging that a generic not be approved. Another delay can result when a drug is dispensed from a unique dispenser. The FDA considers this a "combination product" and generic versions must be similar in both drug and device. Mylan used these two factors to delay approval of a generic EpiPen. The company filed a petition with the FDA in 2015 requesting that Teva's generic product be rejected because the generic autoinjector device was not identical to Mylan's and could cause confusion for consumers. The FDA denied Mylan's petition, but still refused Teva's original application for the generic version.


EpiPen currently costs more than $700 for a pack of two pens. Mylan also offers what it calls a generic version of its EpiPen. It is the same medication and device, made in the same manufacturing facilities, but without the trade name packaging. It retails for $300.


The FDA has approved two additional epinephrine delivery devices, Auvi-Q and Adrenaclick, but they are not considered generic versions of the EpiPen because their delivery devices are not the same. These products, which account for about 25% of the epinephrine sold in autoinjectable devices, cannot be substituted for EpiPen without specific authorization from the prescriber.


Auvi-Q, a talking epinephrine autoinjector, was originally sold by Sanofi but was removed from the market in late 2015 because of inaccurate delivery of the full dose. A different manufacturer, Kaleo, purchased the drug and device and brought it back to the market in February 2017 at an astronomical list price of $4,500 for a package of two autoinjectors. Kaleo guarantees that consumers with commercial insurance will pay only $360, with the expectation that the insurance companies will pay the remaining cost. For consumers without insurance and a household income of less than $100,000, Kaleo offers to provide the drug for free. This business model indirectly drives up the cost of health care, as insurance companies are likely to increase premiums in response to having to pay the balance for some consumers.


The Adrenaclick epinephrine autoinjector device differs from Mylan's EpiPen in two ways. It lacks EpiPen's built-in needle protection shield, and it has two safety shields that must be removed, as opposed to EpiPen's one. Adrenaclick lists for $400 for a pack of two. A generic version of Adrenaclick, manufactured by Lineage Therapeutics, can be purchased through CVS pharmacies for $110. Generic Adrenaclick, like generic EpiPen, is identical to the trademarked product but is sold without the trade markings on the packaging. Adrenaclick and its generic version continue to have a very small market share. Because Ad-renaclick doesn't have the same brand recognition as EpiPen, health care providers may not prescribe it. The variation in administration techniques may also make providers leery of the product, fearing that patients may not be able to manage preparing and injecting the drug. Moreover, the FDA does not consider Adrenaclick therapeutically equivalent to EpiPen because of a lack of evidence. In some states, schools are mandated to stock EpiPens (by trade name) in order to be compliant with the 2013 School Access to Emergency Epinephrine Act. Mylan thus has a legal monopoly on epinephrine injectors. State legislatures would need to rewrite the laws to allow for other trade names of epinephrine to be used.


NPs can prescribe a generic epinephrine product to help patients afford this lifesaving drug. Patient education is crucial when using either the brand-name or a generic product. If the patient is switched from EpiPen or its generic to generic Adrenaclick, or vice versa, instruction including hands-on practice is necessary to confirm the patient is comfortable administering the medication. Nurses, such as school nurses, who work with populations prescribed generic epinephrine self-injectables, need to be comfortable with the injection techniques to safely and accurately administer the drug and provide appropriate education.


To read the FDA news release regarding the approval of Teva's generic EpiPen, go to