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Klobuchar: Shortage of Critical Childhood Cancer Drug Averted, Calls on Congress to Pass Drug Shortage Legislation to Help Prevent Future Shortages

FDA and top manufacturers avert shortage after Klobuchar urged companies to take all necessary steps to rapidly increase production; Klobuchar has introduced legislation to help prevent shortages of critical drugs

February 21, 2012

WASHINGTON, D.C. –U.S. Senator Amy Klobuchar today called on Congress to pass her drug shortage legislation sponsored by U.S. Senators Bob Casey (D-PA) and Susan Collins (R-ME) after the FDA and drug manufacturers announced they were able to avert a further shortage of the critical childhood cancer drug preservative-free Methotrexate. Last week Klobuchar wrote a letter to top manufacturers of preservative-free Methotrexate (MTX), a drug used to treat children with acute lymphoblastic leukemia (ALL), and urged the companies to take all necessary steps to rapidly increase production to 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 relieved that the FDA and the top manufacturers of this vital drug were able to boost production and help ensure that patients can get the medication they need. Today’s action underscores why Congress must 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. Today’s announcement will mean hospitals and pharmacies should be receiving additional shipments of preservative-free Methotrexate in the coming days and 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.

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