WASHINGTON -- February 21, 2012 -- The Food and Drug Administration (FDA) today announced that it is taking major steps to address a critical shortage of cancer drugs that has left patients without lifesaving medications such as Doxil and Methotrexate.
"The actions announced today will help to boost the supply of some of the most badly needed cancer drugs by patients across the country," said J. Leonard Lichtenfeld, MD, deputy chief medical officer of the American Cancer Society, who attended the announcement. "It is critical that the FDA ensure that the added supply of these drugs is safe and made easily available to the patients who urgently need them."
The American Cancer Society and its advocacy affiliate, the American Cancer Society Cancer Action Network (ACS CAN), have been closely monitoring the growing drug shortage crisis, which has made it difficult or impossible for some cancer patients to get the medications they need to save their lives. The overall number of drugs in shortage has grown dramatically in recent years, from 56 drugs in 2006 to a record 178 drugs in 2010. More than 275 drugs were reported in shortage in 2011. In some cases, cancer patients and their families have been completely unable to obtain necessary drugs. In other cases, patients have been forced to pay exorbitant prices through the emerging "grey market," where drugs in short supply are sold legally at a reported cost of up to 650 percent of the original price.
Those families include Sara Stuckey, a Society volunteer from Lincoln, IL, who was told by her doctor that she may soon be unable to access the drug Methotrexate for her 6-year-old son, Nate, who is suffering from acute lymphoblastic leukemia. Stuckey, who attended today's FDA announcement, says her son's life could depend on their ability to get the drug.
"Today's announcement is a critical step forward that will help to put lifesaving medications in the hands of people with cancer, but by all accounts there is much more to be done to resolve the drug shortage crisis," said Christopher W. Hansen, president of ACS CAN. "We urge pharmaceutical companies, distributors and other stakeholders to work with the administration, Congress and the patient community to find a solution to this urgent problem."
Experts have cited several possible factors for the drug shortage problem, including:
* Manufacturing difficulties, such as quality control issues that can force the shutdown of production lines or inaccurate projections of demand for a certain drug.
* The small number of companies that have the capacity to increase production of a drug if one manufacturer ceases production of that drug.
* Tight production schedules that are not readily altered if a manufacturing problem occurs or if demand increases faster than anticipated.
The Society and ACS CAN will continue to advocate for a long-term solution that will guarantee the efficient and effective exchange of information as well as a plan to accelerate production of drugs in imminent and existing shortages. A safe and consistent supply of evidence-based therapies is critical to ensure cancer patients have the best opportunity to fight their disease.
About the American Cancer Society
The American Cancer Society combines an unyielding passion with nearly a century of experience to save lives and end suffering from cancer. As a global grassroots force of more than three million volunteers, we fight for every birthday threatened by every cancer in every community. We save lives by helping people stay well by preventing cancer or detecting it early; helping people get well by being there for them during and after a cancer diagnosis; by finding cures through investment in groundbreaking discovery; and by fighting back by rallying lawmakers to pass laws to defeat cancer and by rallying communities worldwide to join the fight. As the nation's largest non-governmental investor in cancer research, contributing more than $3.5 billion, we turn what we know about cancer into what we do. As a result, more than 11 million people in America who have had cancer and countless more who have avoided it will be celebrating birthdays this year. To learn more about us or to get help, call us any time, day or night, at 1-800-227-2345 or visit www.cancer.org.
About ACS CAN
ACS CAN, the nonprofit, nonpartisan advocacy affiliate of the American Cancer Society, supports evidence-based policy and legislative solutions designed to eliminate cancer as a major health problem. ACS CAN works to encourage elected officials and candidates to make cancer a top national priority. ACS CAN gives ordinary people extraordinary power to fight cancer with the training and tools they need to make their voices heard. For more information, visit www.fightcancer.org.
FOR MORE INFORMATION, CONTACT:
Alissa Crispino or Steven Weiss
American Cancer Society Cancer Action Network
Phone: (202) 661-5772 or (202) 661-5711
Email: [email protected] or [email protected]