February 21, 2012
FDA Rushes To Fix Shortage Of Cancer Drugs
The Food and Drug Administration (FDA) announced plans on Tuesday to help resupply the U.S. with two leading cancer drugs.
The agency said they will address shortages of two leading cancer drugs by allowing one of them to be imported from abroard, and rush approval for a new manufacturer to make the second.
"We're not out of the woods," Dr Sandra L Kweder of the Food and Drug Administration's drug center told the New York Times. "But these two particular shortages have been very, very upsetting to patients and to us."
The FDA said it will allow imports of a version of the cancer drug Doxil in the next few weeks, satisfying doctors and patients who have been forced to postpone care or to use alternatives.
The imported drug is called Lipodox and has the same active ingredient as Doxil, which is doxorubicin.
The agency announced it will also approve APP Pharmaceuticals to make methotrexate, which is a drug used to treat childhood leukemia, ovarian cancer and multiple myeloma.
The FDA said it reached a limited, temporary arrangement for importing Lipodox from Sun Pharmaceutical Industries.
Doxil has been in short supply since manufacturing problems surfaced at the plant Ben Venue, a unit of Boehringer Ingelheim.
Problems at the plant also contributed to a shortage of methotrexate, which lead the FDA to take action so medical practices would not run out of the drug entirely.
Ben Venue said last week that it would release reserves of methotrexate that were made before it shut down the plant last November.
According to analysis from the IMS Institute for Healthcare Informatics, over half a million cancer patients were affected by a short supply of drugs last year.
Doxil is one of 287 drugs that have been in short supply in the past year, according to the University of Utah's Drug Information Service.
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