FDA Acts to Stem Shortage of 2 Cancer Drugs

(REUTERS) - The Food and Drug Administration plans to address 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.

The move announced on Tuesday is the latest government effort to stem the shortages of drugs in the United States, which doctors and patient advocates say have forced providers to postpone care or use second-best or costlier alternatives.

The FDA will allow imports of a version of the cancer drug Doxil, which, in the next few weeks, should meet patient needs, the agency said. The drug version is called Lipodox and has the same active ingredient as Doxil, doxorubicin.

The FDA will also approve a new company, APP Pharmaceuticals, to make methotrexate, a drug used to treat childhood leukemia. APP is a unit of German healthcare group Fresenius SE.

Doxil, a cancer drug from 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.

The injectable drug, which has annual global sales of about $500 million, is used to treat ovarian cancer and multiple myeloma. The FDA said it had reached a limited, temporary arrangement for importing Lipodox from Indian drugmaker Sun Pharmaceutical Industries and its distributor 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 the manufacturers amid fears that U.S. medical practices were close to running out of the drug entirely within a few weeks.

In response, Ben Venue said last week it would release reserves of methotrexate that were made before it shut down the plant last November.

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 had risen to 220 in 2011 from 56 in 2006 -- the year a clear trend started emerging.

The agency said it will also release guidelines for manufacturers to inform the FDA about looming shortages, as early notification can help prevent them.

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