FDA: New Drug Shortages Halved, Cancer Therapy Highlighted

Six Months Since Obama Order

Nick Mulcahy

May 04, 2012

May 4, 2012 — So far, the number of new drug shortages in the United States in 2012 is half that of the same time period last year, according to the US Food and Drug Administration (FDA).

There have been 42 drugs newly reported as being in shortage in 2012, compared to 90 at this time last year, writes Margaret Hamburg, MD, the FDA commissioner, in an FDAVoice blog entry posted yesterday.

Dr. Hamburg wrote the blog post as an informal report to mark the 6-month anniversary of President Barack Obama's signing of an executive order to help the FDA do battle with prescription drug shortages.

The other major accomplishment in the 6 months since the executive order is the prevention of 128 shortages, according to the report.

"Early notification to [the] FDA of potential disruptions in [the] drug supply has made a huge difference in our efforts — and the numbers really tell the story. Since reaching out to industry, there has been a 6-fold increase in early notifications from manufacturers," writes Dr. Hamburg.

I am both amazed and delighted to see the progress.

"I am both amazed and delighted to see the progress that's been made," she notes.

The FDA commissioner highlights the status of 4 cancer drugs in the report.

Supplies of one version of methotrexate, used in the treatment of childhood leukemia, osteosarcoma, and adult cancers, are "currently meeting all demand, and we do not expect any further supply issues," she writes. The resolution of the methotrexate shortage, which was so dire that a prominent pediatric oncologist warned earlier this year that "children will die," was announced in February, and was reported at that time by Medscape Medical News.

Dr. Hamburg also highlights the revised status of liposomal doxorubicin (Doxil), used for ovarian and other cancers. The FDA "exercised enforcement discretion" to import from India another brand of liposomal doxorubicin (Lipo-Dox), thus "meeting patient needs until Doxil is available again," she says, summarizing a situation that was reported in February.

The FDA is attempting to improve the supply of leucovorin injection, which is used along with methotrexate for pediatric leukemia. "We are working with the manufacturer, Teva Pharmaceuticals, to produce additional shipments in the coming weeks to help improve supplies," says Dr. Hamburg.

Also, mechlorethamine (Mustargen), which is used in multiple cancer regimens, will be available again by August, thanks to cooperation between the FDA and the manufacturer, she reports.

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