FDA takes steps increase supply of cancer drugs

A host of prescription drugs have been in low supply around the United States for some time, but doctors have been warning about a particularly acute shortage of a set of life-saving cancer drugs.

Now the U.S. Food and Drug Administration said today that it has taken steps to boost the supply of those cancer drugs -- Doxil, or doxorubicin hydrochloride liposome injection, and methotrexate.

On Doxil, the FDA plans to import temporarily a replacement drug called Lipodox to meet patient needs in coming weeks. On methotrexate, the agency expedited review of the application from the manufacturer APP Pharmaceuticals to make the necessary preservative-free drug here. Another maker, Hospira, expedited release of additional supplies, which go out today and should last a month.

The FDA has been working for some time to get the drug companies to notify the agency when shortages appear to be coming within six months. Officials have release draft guidance to industry on mandatory and voluntary notifications per an executive order from President Obama in October.

Since then, the publicity has produced a sixfold increase in voluntary notices of potential shortages, and the FDA said 114 of them were averted.

Doxil is used for many types of cancer, including ovarian cancer after other drugs failed. It’s also used for AIDS-related Kaposi’s sarcoma and multiple myeloma. Methotrexate also is used to treat multiple kinds of cancer, including acute lymphocytic leukemia in children and for osteosarcoma.

The shortage of methotrexate is partially attributed to the largest manufacturer, Bedford/Ben Venue, closing its plant. But there are several reasons for other shortages, including unclean plants closing, increased demand and drug companies switching to more profitable drugs.

In addition to the administration action, Congress is considering a bill to require all shortages to be reported to the FDA and give the agency enforcement power. Other lawmakers are investigating the shortages.

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