Kirsten Gillibrand United States Senator for New York

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With 14 Lifesaving Cancer Drugs in Short Supply and Over 100 Drug Shortages This Year Alone, Gillibrand, Parents, and Doctors Urge Congress to Pass Legislation This Week Providing Relief for Sick Patients, Children

New Federal Legislation On the Senate Floor This Week Would For First Time Require All Drug Makers to Give FDA Early Warning Signs of Shortage, Hold Companies Accountable By Penalizing Manufacturers That Fail to Comply

May 20, 2012

New York, NY – With over 100 drug shortages reported this year, including 14 lifesaving cancer medications currently in short supply, and a record-high 267 drug shortages in 2011, U.S. Senator Kirsten Gillibrand today urged Congress to pass legislation this week to combat drug shortages. 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.  Gillibrand, joined by doctors and families who needed access to medicine to treat their children’s serious diseases, urged the Senate to pass a common-sense bipartisan bill expected to come up for a vote this week which would require drug manufacturers to alert the Federal Drug Administration (FDA) at least 6 months before a potential shortage. Gillibrand also announced her support for an amendment that would hold manufacturers accountable by enforcing fines against those who fail to report a drug shortage.  

“No parent should wait and worry over whether or not their child has access to life-saving medicine,” said Senator Gillibrand. “Congress must act now to prevent putting future children’s lives at-risk and ensure that New York families are getting the care they need and deserve.” 

“Without the needed treatment for our teenage son Jack, who has Acute Lymphoblastic Leukemia, he would not be here today,” said Jill Cloonan, Long Island parent who faced shortage fears for her 18 year-old son earlier this year. “It is baffling to think that there is a shortage of the medication used to cure one of one of the deadly diseases of children. Jack's strength and survival of three liver transplants as an infant help him hold onto the hope of a healthy future. He has never given up - and it is our responsibility to ensure that he receives essential medication. We stand with Senator Gillibrand and will do everything we can to prevent the loss of this incredible young life due to a drug shortage.” 

“As a parent of a childhood leukemia survivor and a board member of The Children’s Cause for Cancer Advocacy, I am outraged that our children are not better protected against drug shortages. My son was treated with methotrexate, one of the drugs in short supply, and his treatment would have been compromised had he not had access to that drug,” said Susan Scherr, New York City parent and board member of Children’s Cause for Cancer Advocacy. “We must do everything in our power to ensure that all cancer patients have access to the drugs required for treatment.” 

“We continue to experience shortages in essential cancer drugs that place some of our patient’s lives at risk,” said Dr. James Speyer, Medical Director of NYU's clinical cancer center.  “For all of our patients the prospect of further drug shortages looms enormous and adds an unacceptable burden to an already difficult situation.”

“There is no excuse for lifesaving medications to be in short supply, to threaten the chance of cure and to add to the stress our families are already facing,” said Dr. Birte Wistinghausen, Clinical Director of Pediatric Hemotology and Oncology at Mount Sinai Hospital. “Having to cope with the diagnosis of cancer in a child is one of the most difficult experiences in a parent’s life. Over the past two to three decades, the cure rates for childhood cancer have increased significantly and now we expect that more than 70% of our patients get cured of their disease. I thank Senator Gillibrand for fighting to provide the relief our families need.”

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. Earlier this year, the shortage of methotrexate, which is used to treat childhood leukemia and has a cure rate of over 90%, and Doxil, used for ovarian cancer and AIDS-related Kaposi's sarcoma, threatened lives across the country. To ease the shortage, the FDA temporarily allowed shipments imported from abroad to increase supply of these critically needed cancer medicines. 

The FDA Safety and Innovation Act would require 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 expedite a backlog of generic drugs awaiting FDA approval. 

In December 2011, the FDA issued a rule requiring a limited number of manufacturers to report potential shortages, which has averted hundreds of shortages last year. Last year, President Obama issued an executive order requiring drug companies to voluntarily notify the FDA of drug shortages. Senator Gillibrand urged Congress to take further steps by requiring all manufacturers to mandatorily report potential drug shortages. 

To hold companies accountable, Senator Gillibrand is also pushing for an amendment authored by Senator Richard Blumenthal (D-CT) that gives the FDA authority to penalize manufacturers who knowingly fail to report a drug shortage. Companies may be fined $10,000 each day, up to $1.8 million.

Below lists 14 cancer medicine used to treat or manage critical diseases that are currently in short supply. 9 out of the 14 medicine are used to treat children with cancer.   

Pediatric Cancer Drug

Treatment/Management for Disease

1

Daunorubicin

Acute myeloid leukemia (AML);
Acute lymphoblastic leukemia (ALL)

2

Leucovorin

Childhood leukemia

3

Ifosfamide

Ewing’s sarcoma (bone tumor that affects children); osteosarcoma (bone cancer); neuroblastoma
(common form of cancer in infants)

4

Thiotepa

Breast and ovary cancer; bone marrow transplant; leukemia

5

Doxorubicin

Bladder, breast, lung, stomach and ovarian cancer; Hodgkin’s lymphoma (cancer from white blood cells); non-Hodgkin’s lymphoma;  ALL; bone sarcomas; neuroblastoma; Wilms’ tumor (kidney cancer that affects children)

6

Mesna

Protects bladder wall from harmful effects of cancer drugs such as cyclophosphamide (used in treating aplastic anemia) and Ifosfamide (see column #3)

7

Vinblastine

Langerhans’ cell histiocytosis (children with too many white blood cells); Hodgkin’s lymphoma

8

Paclitaxel

sarcomas (cancer in certain tissues such as bone or muscle)

9

Sodium Bicarbonate

Non-Hodgkin’s lymphoma; ALL; osteosarcoma (protects bladder wall from high doses of methotrexate); tumor lysis Syndrome, (series of metabolic disturbances that occur after  cancer treatment)

Cancer Drug

Treatment/Management for Disease

10

Liposomal Doxorubicin

Advanced ovarian and breast cancer; AIDS-related Karposi’s sarcoma; myeloma (bone marrow cancer)

11

Floxuridine

Colon or stomach cancer that has spread to the liver

12

Theracys BCG

bladder cancer

13

Mechlorethamine

Hodgkin’s disease; lymphosarcoma (cancer in the lymph nodes); certain leukemias

14

Mitomycin

bladder, stomach and pancreas cancer

   

 

 

Source: Memorial Sloan Kettering Cancer Center