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 283 prescription drugs are currently 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.
The Food and Drug Administration said yesterday 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 after J&J’s contract manufacturer had to shut down because of 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 FDA also has approved the release of a batch made by Ben Venue Laboratories shortly before it halted manufacture at its complex in Bedford, Ohio, because of quality problems. That closing was what turned the periodic methotrexate shortage that began in late 2008 into a crisis, with fears that kids would begin missing treatments within weeks.
“We have made real progress. … We believe that (suppliers of the two drugs) will be able to meet the demands of patients in the U.S. market” indefinitely, FDA Commissioner Margaret A. Hamburg said. “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 through 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, Hamburg said.
Thanks to such notice, the agency prevented 195 drug shortages in 2011, mostly late in the year after President Barack Obama issued an executive order giving the FDA additional resources to address the shortages. Hamburg said companies have been “very responsive” when the FDA asks them to boost production.
In the latest case, the FDA has temporarily allowed importation of an alternative to Doxil called Lipodox, made by Sun Pharma Global. The Indian drugmaker already sells products in the U.S., and its factory has been inspected.
The FDA is allowing APP Pharmaceuticals to make the preservative-free version of methotrexate in addition to its current drug with preservatives.
On Monday, Hospira Inc. began shipping 31,000 vials of preservative-free methotrexate, more than enough to meet a month’s U.S. demand, to hundreds of hospitals and treatment centers, said its CEO, Mike Ball.
Mylan Inc. and Sandoz Inc. also are ramping up production of preservative-free methotrexate.
Drug shortages have increased dramatically in the U.S. in the past six years, particularly for generic injected drugs. They are the workhorses of hospitals but are difficult to make and produce little profit for drugmakers. At least 15 deaths since 2010 have been blamed on the shortages.
Doctors have had to resort to second-choice drugs that don’t work nearly as well, have more-serious side effects or cost much more than one unavailable. For some drugs, there simply isn’t a good alternative.
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.