By LINDA A. JOHNSON, Associated Press
TRENTON, N.J. (AP) — 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 a light at the end of the tunnel 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 Inc., shortly before it closed several factories at its complex in Bedford, Ohio, due to 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 Dr. Commissioner Margaret A. Hamburg told The Associated Press in an exclusive interview. "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, Hamburg said.
Thanks to such notice, the agency prevented 195 drug shortages in 2011, mostly late in the year after President Obama issued an executive order giving FDA additional powers to address the shortages. Between that order on Oct. 31 and this week, the agency has prevented a total of 114 drug shortages.
Hamburg said that when FDA's much-expanded drug shortages team is notified about impending shortages and contacts other manufacturers, those companies have been "very responsive" as FDA worked with them on finding ways to boost production.
In the latest case, the FDA said it has temporarily allowed importation of an alternative to Doxil called Lipodox, made by Sun Pharma Global FZE. The Indian drugmaker is already known to the agency, and its factory and the production line for Lipodox have been inspected.
The FDA also has given approval to APP Pharmaceuticals LLC 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 Inc., 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.
Still, hundreds of other drugs remain in short supply, including many other cancer medicines.
"I don't think we can ever close the book on drug shortages," Hamburg said. "I think we will always have to be vigilant."
Drug shortages have increased dramatically in the U.S. over 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, which have set a record high in each of the last five years.
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.