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FDA fights shortage problem, OKs sources of 2 cancer drugs

By Michael Muskal, Los Angeles Times –

LOS ANGELES — The Food and Drug Administration has moved to increase the supplies of two needed cancer-treatment drugs and on Tuesday issued a draft guidance on how to cope with the problem of drug shortages.

The federal agency announced that it will temporarily allow the importing of a replacement drug for Doxil, a drug used in the treatment of ovarian and other cancers that has been unavailable for new patients for months.

It also said it has approved another supplier for a preservative-free version of methotrexate, a drug used for children with one type of leukemia and for treatment of bone cancer. Preservatives in the drug can cause problems for children and for those getting high doses as part of their cancer treatment. Adequate methotrexate supplies have been a problem since about 2008.

“A drug shortage can be a frightening prospect for patients, and President Obama made it clear that preventing these shortages from happening is a top priority of his administration,” FDA Commissioner Margaret A. Hamburg said in a prepared statement. “Through the collaborative work of FDA, industry and other stakeholders, patients and families waiting for these products or anxious about their availability should now be able to get the medication they need.”

Drug shortages are a periodic woe and the Obama administration has stepped up its efforts to deal with the problem by getting advance information of impending difficulties from manufacturers. On Tuesday, the FDA increased its requirements for mandatory and voluntary notification of issues that could disrupt the supply chain, a step building on the executive order signed by the president Oct. 31.

According to the FDA, 195 drug shortages were prevented in 2011, 114 of which came after the executive order.

More than 180 drugs have been in short supply in just the last year, with cancer treatment medications usually getting the most publicity. In addition to the executive order, there is legislation pending in Congress to toughen the reporting requirement for companies facing production problems.

Some of the difficulty is also at the manufacturing end rather than just informational, the FDA acknowledged.

“While additional manufacturing capacity is necessary to fully address the drug shortage problem, additional early notification to FDA can have a significant, positive impact on addressing the incidence and duration of drug shortages,” according to the FDA statement.

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