- - Tuesday, February 21, 2012

TRENTON, N.J. — Federal regulators have approved new suppliers for two crucial cancer drugs, easing critical shortages that had been ratcheting up fears that patients, particularly children with leukemia, would miss lifesaving treatments.

But there are currently 283 prescription drugs in short supply or unavailable nationwide, and regulators and manufacturers say shortages are a long-term problem that will continue to give patients and doctors nightmares.

On Tuesday, the Food and Drug Administration said it will temporarily allow importation of a replacement drug for Doxil, a drug for recurrent ovarian and bone-marrow cancer. The Johnson & Johnson drug hasn’t been available for new patients for months because J&J’s contract manufacturer had to shut down production because of serious quality lapses.

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The FDA also has approved a new supplier for a preservative-free version of methotrexate, a crucial drug for children with a type of leukemia called ALL, for lymphomas and for the bone cancer osteosarcoma. The version with preservatives, the one that has been scarce, can be toxic or cause paralysis in children and other patients getting the drug either by injections into spinal cord fluid or at very high doses.

The FDA also has approved the release of a batch manufactured by Ben Venue Laboratories Inc., shortly before it closed several factories at its complex in Bedford, Ohio, because of serious quality problems. That closing was what turned the periodic methotrexate shortage that began in late 2008 into a crisis almost overnight, with fears that children would begin missing treatments within weeks.

“We have made real progress. … We believe that [suppliers] will be able to meet the demands of patients in the U.S. market” for the two drugs indefinitely, said Dr. Margaret A. Hamburg, FDA commissioner. “It’s a huge relief for us.”

Numerous medical and drugmaker groups, along with the White House, applauded the news but cautioned that much still must be done to resolve all the problems causing shortages.

The FDA increasingly has been able to prevent shortages, mainly because of a sixfold increase in manufacturers voluntarily notifying the FDA when they anticipate shortages and agency efforts to expedite any approvals needed for new production lines, Dr. Hamburg said.

Thanks to such notice, the agency prevented 195 drug shortages in 2011, mostly late in the year after President Obama issued an executive order giving FDA additional resources to address the shortages. Dr. Hamburg said companies have been “very responsive” when FDA asks them to boost production after another company warns it will halt a drug’s production.

In the latest case, the FDA has temporarily allowed importation of an alternative to Doxil called Lipodox, made by Sun Pharma Global FZE. The Indian drugmaker already sells products in the U.S., and its factory has been inspected.

The FDA is allowing APP Pharmaceuticals LLC to make the preservative-free version of methotrexate in addition to its current drug with preservatives. The company had made a preservative-free version years ago, but needed to update paperwork and meet other requirements, which the FDA expedited.

“Within the next four to six weeks, we can supply clinics with this drug,” Mitchell L. Ehrlich, a vice president with APP parent Fresenius Kabi USA, said during a Washington news conference announcing the new steps.

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