May 24, 2012

Gillibrand Announces Senate Passage of Legislation to Provide Relief for Sick Patients & Children, Ensure Access to 14 Life-Saving Medicines Currently in Short Supply

Newly Passed Federal Legislation Will For First Time Require All Drug Makers to Give FDA Early Warning Signs of Shortage, Inspect Foreign Facilities that Import Drugs into U.S.

Washington, DC – U.S. Senator Kirsten Gillibrand (D-NY) today announced that the U.S. Senate passed legislation that will combat drug shortages, expedite approval process for life-saving medicines, enhance safety monitoring of devices after clearance and ensure the safety of drugs from foreign manufacturers. The Food and Drug Administration Safety and Innovation Act (FDASIA) passed the full Senate and now heads to the House for a vote. The legislation comes after 100 drug shortages have been reported this year alone, including 14 lifesaving cancer medications currently in short supply, and a record-high 267 drug shortages reported in 2011. The current shortage of 14 cancer drugs, such as daunorubicin, used to treat childhood leukemia, and doxorubicin, used to treat Hodgkin's lymphoma and leukemia, puts young lives in danger.  

Earlier this week, Gillibrand, joined by doctors and families who needed access to medicine to treat their children’s serious diseases, urged the Senate to pass this common-sense bipartisan bill which would require drug manufacturers to alert the Federal Drug Administration (FDA) at least 6 months before a potential shortage. 

“No parent should wait and worry over whether or not their child has access to life-saving medicine.” said Senator Gillibrand. “This common-sense, bipartisan bill brings us one step closer to ensuring that New York families are getting the care they need and deserve. I urge my House colleagues to pass this critical legislation that would quicken review times and prevent putting future children’s lives at-risk.” 

The current shortage of cancer drugs such as daunorubicin, used to treat childhood leukemia, and doxorubicin, used to treat Hodgkin's lymphoma and leukemia, puts young lives in danger. This year alone, over 100 medications have been reported as being in short supply. Between 2005 and 2011, reported drug shortages nearly quadrupled from 55 to 267. According to the Memorial Sloan Kettering Cancer Center, there are currently 14 life-saving cancer drugs in short supply, with nine of them used for pediatrics. The FDA Safety and Innovation Act would require all drug makers to give the FDA early warnings of potential supply problems at least six months in advance. Improving communication between drug makers, the agency and hospitals early on would go a long way towards ensuring that patients have access to treatment they need. 

The bill would also allow the FDA to collect user fees from manufacturers to quicken the review process and expedite a backlog of generic drugs awaiting FDA approval. The bill also speeds up approval for drugs used to treat life-threatening diseases and spurs innovation for the development of new antibiotics for serious infections. 

To hold foreign manufacturers who sell drugs into the U.S. to the same standards upheld by domestic manufacturers, the bill would authorize the FDA to ensure that drugs coming from foreign facilities are safe and effective by overseeing imported drug ingredients and inspecting overseas facilities.