TRENTON, N.J. — Federal regulators said Tuesday that they’ve approved new suppliers for two crucial cancer drugs, easing critical shortages — at least for the time being — that have left patients and parents frightened about missing life-saving treatments.
The news brings relief for some patients, but not for thousands of others, given that there are currently 283 separate drugs in short supply or totally unavailable in this country.
On Tuesday, the Food and Drug Administration said it will temporarily allow importation of a replacement drug for Doxil, a drug for ovarian and other cancers that hasn’t been available for new patients for months.
The agency also has approved another supplier for a preservative-free version of methotrexate, a crucial drug for children with a type of leukemia called ALL and for high-dose treatment of bone cancer. The version with preservatives can be toxic or cause paralysis in children and other patients getting the drug either via 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, shortly before it closed several factories at its complex in Bedford, Ohio, because of serious quality problems.
That closing is what turned the on-again, off-again methotrexate shortage that began in late 2008 into a crisis almost overnight, with fears that patients would begin missing treatments as soon as the end of this month.
“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 Dr. Margaret Hamburg said. “It’s a huge relief for us.”
The FDA increasingly has been able to prevent drug shortages, mainly due to a sixfold increase in manufacturers voluntarily notifying the FDA when they anticipate shortages.
The FDA also has given approval to APP Pharmaceuticals to begin making a preservative-free version of methotrexate in addition to its current drug that includes preservatives.
The company had made a preservative-free version years ago but needed to update paperwork and meet other requirements, which the FDA expedited. It’s expected to start shipping the medication by the middle of March.
Another maker, Hospira, expected today to start shipping about 31,000 vials of preservative-free methotrexate, more than enough to meet a month’s demand, to hundreds of hospitals and treatment centers.
