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SILVER SPRING, Maryland (Reuters) - The U.S. Food and Drug Administration said it will resolve a potentially life-threatening shortage of two leading cancer drugs by allowing one of them to be imported from abroad and rushing approval for a new manufacturer to make the second.
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The moves announced on Tuesday mark the latest government effort to address severe drug shortages. More than 200 medicines were in short supply in 2011 and doctors and patient advocates say the crisis has forced providers to postpone care or use second-best or costlier alternatives.
The FDA will allow imports of an alternative to the cancer drug Doxil, which in the next few weeks should meet all patient needs, the agency said. The drug is called Lipodox and has the same active ingredient as Doxil, doxorubicin.
Late on Friday, the FDA also approved a new company, APP Pharmaceuticals, to make preservative-free methotrexate, a drug used to treat children with leukemia. APP is a unit of German healthcare group Fresenius.
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"We believe we can meet the needs of patients on a continuing basis," FDA Commissioner Margaret Hamburg said at a news conference. "This should resolve the shortages."
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Doxil, a cancer drug marketed by Johnson & Johnson, has been in persistent short supply since manufacturing problems surfaced at a plant of Ben Venue, a unit of German drugmaker Boehringer Ingelheim that has been making the drug under contract.
The injectable drug, which has annual global sales of about $500 million, is used to treat ovarian cancer and multiple myeloma. About 7,000 patients used the drug in the United States before Johnson & Johnson announced a possible supply disruption last June. The company said in January it was able to allocate the drug to 4,400 patients.
The FDA said it reached a limited, temporary arrangement to import Lipodox from Indian drugmaker Sun Pharmaceutical Industries Ltd and its distribution subsidiary, Caraco Pharmaceutical Laboratories Ltd.
Ben Venue's problems have also contributed to a shortage of methotrexate, leading U.S. lawmakers to call for action last week from the FDA and manufacturers amid fears U.S. medical practices were close to running out of the drug entirely within a few weeks.
The medicine has been on the shortage list since last year. It helps treat about 3,500 children a year with acute lymphoblastic leukemia and has cure rates close to 90 percent.
In response, Ben Venue also said last week it would release reserves of methotrexate made before it shut down the plant last November.
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President Barack Obama made shortages a national priority with an executive order in October and the FDA said it has prevented 114 shortages since then, mainly by working with manufacturers.
The FDA has said the number of drugs in short supply, which include cancer, anesthesiology and nutrition medications, had risen to 220 in 2011 from 56 in 2006 - the year a clear trend started emerging. Many of the drugs are generic, sterile injectable medications.
