Lawmakers are concerned about a lack of generic competition in the epinephrine auto-injector market after news broke that the cost of the EpiPen® auto-injector increased over 400 percent since the product’s manufacturer—Mylan—purchased the allergy medication device in 2007. Members of the House Committee on Energy and Commerce sent a letter to FDA Commissioner Robert Califf, on August 29, 2016, seeking answers to questions regarding the FDA’s prioritization and review of competitor products for EpiPen, inquiring specifically as to the agency’s review of abbreviated new drug applications (ANDAs) for generic epinephrine auto-injectors. On the same day, Mylan announced the release of its own generic EpiPen® Auto-Injector, which the manufacturer plans to sell for $300—a 50 percent discount off of its branded product.
The EpiPen is the primary epinephrine auto-injector available in the U.S. for the emergency treatment of life-threatening allergic reactions. In 2007 when Mylan acquired the drug-device combination, the list price for a single EpiPen was $57. The list price for the Epi-Pen 2-Pak® is now $608 (see Mylan attempts to mitigate EpiPen® cost hike controversy, Health Law Daily, August 25, 2016). When news of the price hike spread, Mylan announced it would double eligibility for its patient-access program. The manufacturer is attempting to further increase access through its generic product. With the release of a generic EpiPen, Mylan is offering a product identical to the branded product in terms of functionality and drug formulation. Mylan expects to release the product in several weeks, after labeling revisions are finalized.
The letter from lawmakers to the FDA raises concerns that federal laws and regulations are not adequately tailored to promote a competitive prescription drug market—a fact made apparent by the Mylan EpiPen controversy. The letter asked the FDA Commissioner to answer: (1) how many ANDAs have been submitted to the FDA relying on Mylan’s EpiPen?; (2) has the FDA prioritized review of those ANDAs?; (3) what are the factors the FDA considers when deciding whether to approve an ANDA which references a drug-device combination like EpiPen?; and (4) has the agency issued any guidance documents that would be of interest to a company seeking approval of a generic epinephrine auto-injector?