By: Laura O’Brien
In 2004, Congress passed the Federal Food, Drug, and Cosmetic Act, requiring food labels to include the eight major food allergens: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, and soybeans. Prior to the Act, many foods were mislabeled, or failed to label one or more of these allergens. By mislabeling, or failing to label foods, individuals with allergies were vulnerable to allergic reactions to seemingly safe foods. Allergies, to food, bees, and other common allergens, put approximately 30,000 individuals in the hospital every year due to anaphylactic reactions. Individuals with severe allergic reactions rely on EpiPen’s to provide relief from symptoms. An EpiPen contains epinephrine, otherwise known as adrenaline. One injection from an EpiPen allows for 20 to 30 minutes after injection to suppress the allergic reaction and allow for an individual to reach medical care. Typically, individuals with allergies carry two EpiPen’s to offer either a backup, or an extra 30 minutes.
Pfizer and Mylan, the drug maker and distributor, came under heat for increasing the price to the life-saving device. Pfizer and Mylan were then subject to several lawsuits arising out of the price hike. Pfizer and Mylan have lacked competition in the EpiPen market, essentially having a monopoly in the market. By having a monopoly, the drug companies are able to charge a higher price, and consumers have no option other than to pay what is required. Unlike many other pharmaceuticals, EpiPen’s consist of non-patented epinephrine and a patented injector, the patent is owned by Mylan. Previously, the FDA wouldn’t approve any EpiPen alternative that had a different injector than the one patented by Mylan. As a result, no other pharmaceutical companies were able to produce an alternative that would be approved by the FDA.
Recently, the FDA has announced its commitment to expedite the approval process for alternative treatments. As a result, the FDA recently approved an auto-injector from the Israel based pharmaceutical company, Teva, creating competition for Pfizer and Mylan. Although Mylan introduced a generic EpiPen in 2016, this introduction did not create competition between companies, allowing Mylan and Pfizer to continue to sell both products at a high price. The FDA hopes the introduction of competition into the market will allow for lower prices, and more accessibility to those who need the life-saving drug.
In 2017, Mylan recalled several lots of EpiPen’s due to potential defects. The recall resulted in the FDA reprimanding Pfizer for failing to investigate complaints they hade received about EpiPen failures, some of which resulted in death. More recently, a shortage of EpiPen’s has continued, causing concern for parents of children with allergies going back to school who can’t seem to track down any pharmacies that are stocked with EpiPen’s.
Although the approval of the generic gives hope for those who need EpiPen’s and haven’t been able to afford or find them, the approval will not allow immediate relief. The shortage will continue until manufacturing and distribution can catch up with the need.
Sonja Haller, How parents can find a lifesaving EpiPen for their kids during current shortage, USA Today (Aug. 22, 2018), https://www.usatoday.com/story/life/allthemoms/2018/08/22/find-epipen-parents-can-try-3-things-find-one-during-shortage/1065096002/.
Nathan Bomey, FDA approves first generic EpiPen in blow to Mylan, USA Today (Aug. 08, 2018), https://www.usatoday.com/story/money/2018/08/16/generic-epipen-teva-pharmaceuticals-mylan/1010118002/.
Avik Roy, FDA’s New Generic EpiPen Approval Exemplifies Progress on Drug Price Reform, Forbes (Aug. 23, 2018), https://www.forbes.com/sites/theapothecary/2018/08/23/fdas-new-generic-epipen-approval-exemplifies-progress-on-drug-price-reform/#.
Joseph Walker, EpiPen Shortage Hits Back-to-School Season, The Wall Street Journal (Aug. 25, 2018), https://www.wsj.com/articles/epipen-shortage-hits-back-to-school-season-1535202001.
FDA approves Teva’s generic of Mylan’s EpiPen, 25 No. 14 Westlaw J. Med. Devices 08 (2018).