Leukemia drug shortage averted for now, FDA says

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Disaster averted, say federal health officials. HHS Secretary Kathleen Sebelius told Congress yesterday that new supplies of the critically scarce drug methotrexate would be released in the coming days--enough to ease fears that children with leukemia would have to go untreated.

Three manufacturers, Mylan ($MYL), Hospira ($HSP), and Sandoz, are promising additional supplies by month's end. Mylan says it's working to boost capacity, while Hospira is still producing some methotrexate despite its inability to source more of the drug's active ingredient. A fourth--Ben Venue Laboratories, whose plant shutdown touched off the shortage--will release batches made before it put its Bedford, Ohio, plant on idle. In fact, those batches will start shipping today, The Wall Street Journal reports.

"We hope this supply will help address near-term patient needs while other companies licensed to manufacture methotrexate increase production," Ben Venue said in a statement. FDA told PBS NewsHour Ben Venue was taking steps to ensure its shipments weren't affected by the potential contamination problems and other manufacturing shortfalls that forced its plant to shut down for fixes.

The new methotrexate shipments are good news for those patients, but the flurry of activity only underscores the need for long-term help for drug shortages, which have hit unprecedented levels in recent months. Several lawmakers have introduced bills that would, for one thing, set up early-warning systems so the FDA would have more time to look for alternatives. But that might not be enough; some experts say prices for these drugs could simply be too low to incentivize drugmakers to continue making them on the one hand--and to keep their plants in top condition on the other.

- see the WSJ piece
- get more from PBS
- read the NPR coverage
- find a statement from the American Society of Hematology

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