Gillibrand wants alerts on drug shortages

Senator Kirsten Gillibrand, Dr. Birte Wistinghausen, Clinical Director of Pediatric Hemotology and Oncology at Mount Sinai Hospital, Jack Cloonan, 18, Rich Cloonan, father, and Jill Cloonan, mother, (speaking at podium) during a news conference in Manhattan to urge Congress to pass legislation to combat drug shortages. The Cloonan family is from Coram. (May 20, 2012) Credit: Office of U.S. Senator Kirsten Gillibrand
Sen. Kirsten Gillibrand wants to stop future shortages of cancer drugs by requiring the manufacturers to give six months' notice before supplies run scarce, saying not doing so puts patients in danger.
Gillibrand (D-N.Y.) urged the Senate to pass a bill, expected to come up for a vote this week, that would require drug manufacturers to alert the Federal Drug Administration of impending shortages six months beforehand.
"Parents should not have to worry and wait in line for lifesaving medicines that they desperately need," Gillibrand said Sunday at a news conference in her Manhattan office.
She also voiced support for legislation that would hold manufacturers accountable by fining them $10,000 a day and up to $1.8 million for failing to report a drug shortage.
Called the FDA Safety and Innovation Act, the bill would also expedite a backlog of generic drugs awaiting FDA approval.
Cancer drugs such as daunorubicin, used to treat childhood leukemia, and doxorubicin, used to treat Hodgkin's lymphoma and leukemia, are now in short supply. They are two of 100 drug shortages reported so far this year, Gillibrand said.
"Now we are not even halfway through 2012 and we already have 100 drug shortages reported," Gillibrand said. "Last year, there was an all-time high of 267 reported drug shortages . . . We must do better."
Jill Cloonan, of Coram, understands the seriousness of a drug shortage.
Her son Jack, 18, missed the last two years of high school while battling a life-threatening immune system disorder when he was diagnosed with acute lymphoblastic leukemia last August.
Not only was the family faced with yet another illness but then in February they learned that the drug needed to treat the new illness -- methotrexate -- was in short supply. That's when Cloonan decided to contact local lawmakers, including Gillibrand, for help.
"It was of kind of devastating to find out," Cloonan, 53, said in a telephone interview. "What's worse than being told that your child has a deadly disease is that it's curable but the cure is not available. It's like dangling a carrot in front of your face: 'Look it's available but you can't have it.' "
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