Letter to Hospira, Inc., Mylan, Inc., Sandoz, Inc. and APP Pharmaceuticals

Letter

U.S. Senator Amy Klobuchar today called on drug manufacturers to boost production of a critical childhood cancer drug that has been placed on the drug shortage. In a letter to the top manufacturers of Methotrexate (MTX), a drug used to treat children with acute lymphoblastic leukemia (ALL), Klobuchar urged the companies to take all necessary steps to rapidly increase production and help alleviate the shortage. Klobuchar has introduced legislation that would give the Food and Drug Administration (FDA) the tools it needs to help prevent drug shortages.

"Families fighting childhood cancer should not have to worry about where they're going to get the next dose of the drug they need to save their child's life," Klobuchar said."I am asking the manufactures of this vital drug to boost production and help ensure that patients can get the medication they need, and I will continue to work to pass critical legislation that will help prevent these types of shortages from wreaking havoc on families' lives."

Preservative-free Methotrexate is critical to the treatment of children with ALL. Approximately 3,500 children and teenagers are diagnosed with ALL each year, with cure rates approaching 90%. Without this drug, patients are at a dramatically heightened risk of dying. Hospitals and pharmacies are at risk of running out of the drug in a matter of days to weeks.

Last February, Klobuchar and Casey introduced the Preserving Access to Life-Saving Medications Act. The bipartisan bill would require prescription drug manufacturers to give early notification to the FDA of any incident that would likely result in a drug shortage, as well as direct the FDA to provide up-to-date public notification of any actual shortage situation and the actions the agency would take to address them. The FDA prevented nearly 200 drug shortages in 2011 due to voluntary early notifications from companies, up from 38 in 2010. During a recent FDA workshop, FDA officials said that the rise in preventions is due to increased pressure from Klobuchar and other members of Congress.

In October of 2011, President Obama issued an executive order advancing the key provision in the bill, which urged pharmaceutical companies to notify the FDA of impending prescription drug shortages. Additionally, the FDA action took that order one step further by expanding requirements on certain manufacturers of lifesaving, medically necessary drugs.

Klobuchar is a member of a bipartisan drug shortages working group in the Senate, which is aimed at bringing together patients, doctors, pharmacists, manufacturers, and the FDA to stop drug shortages. Last month, Klobuchar held a forum in Edina, Minnesota with Federal Trade Commission (FTC) Chairman Jon Leibowitz and Minnesota Attorney General Lori Swanson to discuss the drug shortages crisis and how to ensure patients have access to affordable medications.

The full text of the letter is below. The letter was sent to Hospira, Inc.; Mylan, Inc.; Sandoz, Inc; and APP Pharmaceuticals.

Dear,

I know that your company has been working hard to increase production of preservative-free Methotrexate (MTX) since production difficulties began last fall. I have been contacted by physicians and institutions throughout the country that are increasingly concerned they will run out of this drug in a matter of days to weeks, and I urge you to do all you can to ensure continued access to this critical medication.

As you know, MTX is vital to the treatment of children with acute lymphoblastic leukemia (ALL). Approximately 3,500 children and teenagers are diagnosed with ALL each year, with cure rates approaching 90%. Preservative-free MTX is part of a treatment regimen that makes this high rate of success possible. I have been contacted by physicians and institutions throughout the U.S. that are increasingly concerned they will run out of this drug in a matter of days to weeks and I urge you to do all you can to ensure continued access to this critical medication.

In my state, I have been contacted by the parents of four year-old Axel Zirbes who is in treatment for ALL in the Twin Cities. This is the second drug shortage his family has faced and I know you join me in extreme frustration that the Zirbes family has to encounter a difficulty like this when they should be focusing on helping Axel manage his treatment and recovery.

I am grateful for everything your company has been doing to address the situation, but I request that you redouble your efforts and explore all avenues possible to rapidly increase access to preservative-free Methotrexate. I know that these are not easy decisions for your company, but we should all be doing everything we can to avoid the tragedy of not being able to deliver necessary therapy to children and families facing this horrible disease.

Thank you for your efforts. I am committed to working with you, the FDA, and other key stakeholders to expedite response to this critical shortage.

Sincerely,

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