WASHINGTON, D.C. –U.S. Senators Amy Klobuchar (D-MN), Bob Casey (D-PA) and Susan Collins (R-ME) today offered an amendment to legislation currently being considered on the Senate floor in an effort to quickly advance their bipartisan bill to prevent critical drug shortages. After a critical childhood cancer drug Methotrexate was recently placed on the drug shortage list, the Senators said that their drug shortages legislation, which was introduced over one year ago, cannot wait any longer and that urgent action is needed. Klobuchar today also spoke with FDA Commissioner Margaret Hamburg to discuss how to alleviate the current cancer drug shortage.
“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.“Our legislation would help prevent these types of shortages from wreaking havoc on families’ lives, and we must take immediate action to pass this important bill.”
“Patients and hospitals in Pennsylvania and around the country have experienced an inexcusable shortage of life saving drugs,” said Senator Casey.“This action will help ensure that patient care is not jeopardized by a lack of life-saving medication.”
“Physicians, pharmacists, and patients in my state of Maine and throughout the country are struggling to cope with a surge in shortages of drugs that is causing significant disruptions in care and putting patients at risk,” said Senator Susan Collins. “Our legislation would give the FDA the information and tools needed to help address and prevent drug shortages. This would help ensure that health-care professionals are able to provide the best care medical science allows. Most important, it would help ensure that patients have access to the medications that they need to treat their conditions.”
Klobuchar, Casey, and Collins’ bipartisan legislation, the Preserving Access to Life-Saving Medications Act, 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.
Preservative-free Methotrexate recently was added to the drug shortages list. The medication 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.
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.