WASHINGTON – U.S. Sen. Mark R. Warner (D-VA), a member of the Senate Finance Committee, today pressed the only pharmaceutical company that manufactures EpiPens to explain recent increases in the price of the lifesaving injection device for children and other people with severe allergies. It has been reported that costs for the EpiPen have risen more than 400% since 2007.

“Many families across the country, including my own, depend upon access to epinephrine auto-injectors to administer potentially life-saving treatment in the event of severe adverse allergic reactions. The EpiPen, which currently has no generic substitute on the market, made up over 87% of U.S. epinephrine auto-injector prescriptions in 2015, and plays a critical role in ensuring the health and peace of mind for many of the 1 in 13 children with food allergies,” wrote Sen. Warner in a letter to Mylan CEO Heather Bresch. “As the parent of a child with severe allergies, I am all too familiar with the life-or-death importance of these devices, and in Congress I have worked to facilitate access to epinephrine auto-injectors by sponsoring the Airline Access to Emergency Epinephrine Act and the School Access to Emergency Epinephrine Act, both of which have been signed into law.”

An EpiPen injects a pre-measured dose of epinephrine (adrenaline) in the event of a dangerous allergic reaction, known as anaphylaxis, to consuming peanuts, eggs and other foods as well as bee stings and insect bites. While a pair of the devices sold for less than $60 when the pharmaceutical company Mylan bought the rights to produce the EpiPen in 2007, wholesale prices for the drug have risen more than 400% since then. There is no generic equivalent for the EpiPen, and those with high-deductible insurance plans are paying more out of pocket to cover the high costs.

“As students head back to school, schools and parents are restocking on EpiPens, which have a one-year shelf life. However, the price of a two-pack of EpiPens recently increased to $600, a price increase of over 400% since 2007. In recent weeks, I have heard from hundreds of Virginia parents, teachers, and families who have been impacted by this increase,” Sen. Warner noted. “As a member of the Senate Finance Committee, I certainly understand that our health system is designed to encourage and reward pharmaceutical innovation, and that rising costs are often the result of a range of complex factors. However, I am deeply concerned by this significant price increase for a product that has been on the market for more than three decades, and by Mylan's failure to publicly explain the recent cost increase, which places a significant burden on parents, schools and other purchasers of the EpiPen.”

In his letter, Sen. Warner pressed Mylan on what specific factors contributed to recent price increases, and whether Mylan explored reasonable alternatives to the price increase, such as working to extend the product’s one-year shelf life or allowing the purchase of individual EpiPens, which are currently only sold in two-packs.

Up to 6 percent of children have food allergies, according to the Centers for Disease Control and Prevention, and studies have found that up to 18 percent of children with food allergies have had a reaction after accidentally consuming allergens at school.

A copy of the Senator’s letter is available here. The full text also appears below.

 August 23, 2016

 Ms. Heather Bresch

Chief Executive Officer

Mylan

1000 Mylan Boulevard

Canonsburg, PA 15317

Dear. Ms. Bresch,

I write today to inquire about recent reports indicating a significant and to-date unexplained increase in the cost of EpiPens, which are a lifesaving treatment for millions of Americans with severe food and other allergies.

Many families across the country, including my own, depend upon access to epinephrine auto-injectors to administer potentially life-saving treatment in the event of severe adverse allergic reactions. The EpiPen, which currently has no generic substitute on the market, made up over 87% of U.S. epinephrine auto-injector prescriptions in 2015, and plays a critical role in ensuring the health and peace of mind for many of the 1 in 13 children with food allergies.

As the parent of a child with severe allergies, I am all too familiar with the life-or-death importance of these devices, and in Congress I have worked to facilitate access to epinephrine auto-injectors by sponsoring the Airline Access to Emergency Epinephrine Act and the School Access to Emergency Epinephrine Act, both of which have been signed into law. As the result of the Airline Access to Emergency Epinephrine Act, airlines must maintain a supply of epinephrine auto-injectors on commercial aircraft and train flight crews on proper administration. The School Access to Emergency Epinephrine Act encourages states to enact laws requiring schools to have non-student specific epinephrine auto-injectors on hand in case of an emergency, and my home state of Virginia is among those with such a mandate.

As students head back to school, schools and parents are restocking on EpiPens, which have a one-year shelf life. However, the price of a two-pack of EpiPens recently increased to $600, a price increase of over 400% since 2007. In recent weeks, I have heard from hundreds of Virginia parents, teachers, and families who have been impacted by this increase. As a member of the Senate Finance Committee, I certainly understand that our health system is designed to encourage and reward pharmaceutical innovation, and that rising costs are often the result of a range of complex factors. However, I am deeply concerned by this significant price increase for a product that has been on the market for more than three decades, and by Mylan's failure to publicly explain the recent cost increase, which places a significant burden on parents, schools and other purchasers of the EpiPen. As Congress continues to consider questions of value in the pharmaceutical market as a whole, the short-term impact of this spike is devastating. As a result, I write today to respectfully request your response to the following questions:

1. 1.      What specific factors, investments and otherwise, contributed to recent price increases? To what extent did Mylan explore reasonable alternatives to the price increase, such as working to extend the product’s one-year shelf life or allowing the purchase of individual EpiPens, rather than requiring consumers to purchase two injectors at a time?
2. 2.      Does Mylan plan to expand its work with school systems to facilitate EpiPen access?
3. 3.      Insurers and employers may extract price discounts from manufacturers by agreeing to lower cost-sharing, and if a manufacturer is unwilling to offer discounts the insurer or employer may require higher cost-sharing, deterring utilization. Does offering financial assistance to some consumers make it less likely for Mylan to offer price discounts or rebates to insurers? What is Mylan doing to protect consumers from the impact of these price increases, especially for Americans enrolled in high-deductible plans?
4. 4.      While Mylan provides financial assistance to many consumers, depending on their health coverage, many are also ineligible for such assistance. How is Mylan providing assistance to these consumers, including the uninsured, those covered by state or federal programs, and others?
5. 5.      Via coverage under Medicaid, Medicare and other federal and state healthcare programs, the government is a significant purchaser of the EpiPen. To what extent does Mylan anticipate increased costs being borne by the taxpayer, given that the government is not eligible to take advantage of coupons or other cost-saving measures that may be available to other purchasers of the drug?
6. 6.      Emergency medical service providers often face even steeper costs for these devices. What steps has Mylan taken to ensure that EMS providers have access to EpiPens?

While it is critical that our healthcare system continues to function in a way that encourages pharmaceutical innovation, I remain deeply concerned by these increases at a time when parents and students should be able to focus on academics and the start of a new school year, rather than on affording lifesaving medication. EpiPens have long served as a lifeline for millions of American families, including my own, and I strongly urge you to prioritize continued access.

Sincerely,

Mark R. Warner

United States Senator

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