WASHINGTON – Sens. Chuck Grassley (R-Iowa), Patrick Leahy (D-Vt.), Amy Klobuchar (D-Minn.), Richard Blumenthal (D-Conn.) and Ron Johnson (R-Wisc.) today asked the Food and Drug Administration to answer questions about its approval process and other steps for alternatives to the EpiPen, a self-injectable remedy for severe allergic reactions that has been the subject of steep price increases from Mylan, its manufacturer. The price increases have caused concern among parents buying EpiPens for their children with severe peanut and other allergies.
“We are also concerned that the substantial price increase from Mylan could limit access to a much-needed medication,” the senators wrote to Commissioner Robert M. Califf. “Given the importance of this topic, it is imperative to understand the FDA’s role with respect to EpiPens and its approval of generic equivalents that could help to increase competition and lower prices if introduced.”
The senators outlined the cost increases of the EpiPen in the United States compared with lower prices for alternative products in Europe. They said U.S. law, through the School Access to Emergency Epinephrine Act, encourages states to supply such products in schools, and that a number of states have passed laws requiring public schools to have epinephrine. In addition to affecting individual families, the cost of EpiPens could affect school budgets, as well as taxpayer-funded health care programs such as Medicaid.
The senators noted that since market competition affects medication costs, “It would be helpful to understand the [FDA’s] role and impact in this area, given the regulatory authority it exerts over the review and approval of the EpiPen and competitor products.”
The senators sought an explanation of what factors could be behind the lack of competition for the EpiPen. They asked whether the FDA is taking steps to ensure an adequate supply of self-injectable epinephrine, since the number of people with peanut allergies has tripled in the last 20 years. The letter asked whether the FDA has taken steps to ensure an efficient, safe process for alternatives to the EpiPen, without being hampered by backlogs, and whether certain situations such as drug shortages warrant changes to the typical FDA approval timeline. It also asked whether the agency has considered whether the EpiPen could become an over-the-counter medication and for a description of that process. Finally, the senators asked how many alternatives to the EpiPen are under review at the FDA and for a description of where each alternative stands in the process.
The senators’ letter is available here.