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.
There are still 283 separate 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.
Tuesday, the Food and Drug Administration said it will temporarily allow importation of a replacement drug for Doxil, a drug for recurrent ovarian or 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 over quality lapses.
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's 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, due to 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, FDA Commissioner Margaret A. Hamburg told the Associated Press in an exclusive interview. "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 the problems causing shortages.
So far this year, 27 new shortages have been reported, and about 215 that began in 2010 or 2011 remain unresolved, according to Erin R. Fox, manager of the University of Utah Drug Information Service, which tracks shortages.