Blumenthal Demands Mylan Lower Price for Life-Saving Epipen

[WASHINGTON, DC] – In response to exorbitant prices increases for a drug to treat extreme, life-threatening allergic reactions, U.S. Senator Richard Blumenthal (D-CT) today demanded that pharmaceutical company Mylan lower the price of the EpiPen Auto-Injector to an affordable, accessible level. In a letter to the company, Blumenthal said the skyrocketing price threatens to put the life-saving product out of reach for families, schools, and first responders.

“I was both shocked and dismayed to discover that the price of your product, which has not been improved upon in any obvious or significant way, has skyrocketed by 480% since 2009,” the Senator wrote. “My office has been contacted by dozens of concerned Connecticut residents, families, school nurses, and first responders who urgently require your life-saving product but fear that its skyrocketing price has put it out of reach. Due to Mylan’s virtual monopoly of the epinephrine auto-injector market and its unique life-saving attribute, it is crucial that your product remains affordable for all Americans. Therefore, I demand that Mylan take immediate action to lower the price of EpiPen’s for all Americans that rely on this product for their health and safety.”

Blumenthal’s letter references Connecticut families who have contacted his office with their concerns about the price increase. A mother of two children with life threatening allergies, wrote that she spends more than $2,000 each year on EpiPens, stating that “We’ve carried expired EpiPens because we cannot always afford the new ones.” Another concerned parent said, “This is heartbreaking that I work full time and literally cannot afford this medication that would save my beautiful two year old. That’s right. A two year old.”

Senator Blumenthal was an original cosponsor of a bill that passed in 2013 awarding grants to states that require their public elementary schools and secondary schools to maintain a supply of emergency epinephrine. In addition to maintaining a supply of easily accessible epinephrine, these states will be allowed authorized personnel to administer epinephrine to students who experience anaphylactic reactions.  More recently, he supported a proposal requiring epinephrine on airplanes. He has also called for investigations into the price increases of other critical drugs, including Naloxone and Saline.

The full text of today’s letter is available here and below.

Dear Mrs. Bresch,

I am writing to express concern over the well-documented, exorbitant price increases of the EpiPen Auto-Injector sold exclusively by Mylan over the past several years. My office has been contacted by dozens of concerned Connecticut residents, families, and first responders who urgently require your life-saving product but fear that its skyrocketing price has put it out of reach. Due to Mylan’s virtual monopoly of the epinephrine auto-injector market, and its unique life-saving attributes, it is crucial that your product remains affordable. Therefore, I demand that Mylan take immediate action to lower the price of EpiPen’s for all Americans that rely on this product for their health and safety.

As you know, allergic reactions resulting in anaphylaxis are serious and potentially life threatening. Currently, EpiPen Auto-Injectors are the safest and most effective way of delivering an appropriate dose of epinephrine to victims of an allergic reaction, undoubtedly saving thousands of lives each year by preventing anaphylaxis. In order to ensure the efficacy of Epinephrine, it is recommended that the drug be replaced each year, making an EpiPen purchase an annual burden for many.

Congress, along with many states, including Connecticut, have taken significant steps to increase the availability of EpiPens in schools[1] and on ambulances because of its life-saving potential.[2] Indeed, in 2013, I was proud to work with my colleagues in the Senate to pass legislation that would provide grant support to states that require their public elementary schools and secondary schools to maintain a supply of emergency epinephrine. More recently, I have supported a proposal requiring epinephrine on airplanes.[3] Mylan has shared this commitment to expanding access, with a spokeswoman for your company stating, “Mylan has worked tirelessly over the past years advocating for increased anaphylaxis awareness, preparedness, and access to treatment.”[4] However, I am concerned that your company has failed to recognize that affordability in health care is key to ensuring accessibility. When families, schools, and first responders struggle to purchase your product, any effort to mandate its availability becomes an expensive burden that they are forced to bear.

I was both shocked and dismayed to discover that the price of your product, which has not been improved upon in any obvious or significant way, has skyrocketed by 480% since 2009.[5] In Connecticut, I have heard from countless concerned parents expressing their outrage over these seemingly arbitrary price increases. For example, a mother of two children with life threatening allergies, wrote that she spends over $2,000 each year on EpiPens, stating that “We’ve carried expired EpiPens because we cannot always afford the new ones”. Another concerned parent expressed, “This is heartbreaking that I work full time and literally cannot afford this medication that would save my beautiful two year old. That’s right. A two year old. 

Families are not alone in facing the dire consequences of the increasingly unwarranted price of your product. My office has heard from first responders on this issue, with one emergency medical services (EMS) supplier offering “lists of EMS representatives who can show you that EpiPen prices are destroying their EMS budgets.” In fact, first responders in other states have turned to directly injecting epinephrine using syringes, a method that is far less safe but increasingly necessary.[6]  Along with ambulances, schools in Connecticut are also required to stock epinephrine auto-injectors.[7] The costs that Mylan’s price increases have waged not only on individual families, but on each taxpayer in Connecticut, is unacceptable.

In my role on the Senate Special Committee on Aging, I have taken part in hearings on the inexplicable and shameful price increases of various decades-old drugs. All too often, the responses from manufacturers revolve around inadequate rebate programs, complicated discounts, and uncorroborated improvements to the product.  I hope these will not be the same arguments employed by Mylan.[8] In an effort to understand these recent shocking price increases please provide answers to the following questions by September 5^th, 2016:

• Mylan has been quoted as stating that your prices have “changed over time to better reflect important product features and the value the product provides.”[9] What are these changes, and how have they contributed to a more safe or effective product for consumers?
• Mylan’s website highlights a “$0 co-pay” program, stating, “Carry EpiPen® (epinephrine injection) Auto-Injectors wherever you go…and do it for as little as $0.”[10] However, this “savings offer” maxes out at $100. What other programs do you have to help consumers cover the remaining $500 that the underinsured, uninsured, or those with high deductible plans may be forced to pay annually?
• First responders in Connecticut and around the country are struggling to pay for your product. Do you have financial assistance programs to help provide our first responders with the tools they need to save lives?
• Following FDA guidelines suggesting those with “severe allergic reactions” be prescribed two doses of epinephrine, you began exclusively selling twin-packs. You characterized these guidelines as a big event that “[Mylan] started to capitalize on.”[11] Will you consider selling single pens again for those who do not require a twin-pack or simply need a single replacement?

Following Congressional action to make EpiPens more accessible in schools, a move that Mylan advocated for, your company released the following statement: “even one anaphylactic episode without access to epinephrine is one too many.”[12] Thousands of Connecticut residents – from children and their parents to the first responders who keep us safe – would agree. However, the prolonged unaffordability of EpiPens will only continue to serve as a barrier to this lifesaving, and well-established safety measure. Consequently, millions of Americans may resort to other unproven methods of administering an otherwise affordable dose of epinephrine.

Due to the abundance of reports coming from consumers and first responders struggling with the high price of EpiPens, I am calling on you to immediately lower the price of your product to an affordable level that truly allows for expanded accessibility. I look forward to your response and hope we can work together to bring the price of Mylan’s lifesaving product back down to a reasonable level.

Sincerely,

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