The United States FDA has approved the first generic version of EpiPen and EpiPen Jr (epinephrine). The approval was granted to Teva Pharmaceuticals USA, who will now be able to market generic epinephrine in an auto-injector in two strengths: 0.3 mg and 0.15 mg. For more information, you can click here to read the source press release by the FDA.
About EpiPens
EpiPen auto-injectors are used as an emergency treatment for anaphylactic shock. Anaphylactic shock is a potentially life-threatening medical emergency that can be triggered by allergies, such as food, medications, or insect stings. According to the FDA’s press release, an estimated one in fifty Americans are at risk of anaphylaxis.
EpiPen Pricing Controversy
This approval of a generic version of EpiPen and EpiPen Jr follows previous controversy over their pricing. According to CBS News, the cost of an EpiPen increased almost 500% over seven years from just over $100 in 2009 to just over $600 in 2016. The CEO of Mylan has responded the controversy by saying that making EpiPens more accessible by reducing the prices for certain people leads to higher pricing overall.
Encouraging Generic Products
The approval of a generic EpiPen is part of a broader FDA commitment to increasing the number of cheaper generic alternatives to branded medical products. In the source press release, the FDA commissioner Dr Gottlieb says, “this approval means patients living with severe allergies […] have a lower-cost option.”
However, the path towards creating generic alternatives to existing drugs is challenging. The FDA is currently working to provide clear scientific and regulatory guidelines, especially in regards to complex products that can be difficult to reproduce. EpiPens are an example of this because they are made up of the drug epinephrine and the auto-injector device. According to the FDA press release, the organisation encourages the development of generic forms of these complex products by supporting individual companies working to develop generic alternatives. The FDA also provides outlines of recommended steps in the development process. Since 2009, the FDA has published three guidances relating to generic epinephrine auto-injector development. The FDA also inspects manufacturing and packing facilities to make sure that the drugs will be consistently safe and effective.
The approval of a generic form of EpiPen and EpiPen Jr is expected to provide a lower-cost alternative for people with severe allergies and may help to alleviate shortages of the drug. The New York Times reports that Ms Madsen, head of federal advocacy for the Food Allergy Research & Education advocacy group, says of the news, “We’re very excited to have this big win for the food allergy community.”
