"It's hard enough to hear that your child has cancer, but to hear the treatment that's been successful and working is not available is devastating," Stuckey said during the news conference at FDA headquarters in Silver Spring, Md.
Doxorubicin, which is sold by Johnson & Johnson under the trade name Doxil, is used to treat several diseases including ovarian cancer, AIDS-related Kaposi's sarcoma and multiple myeloma. Doxil will be replaced temporarily by Lipodox, which is made by the Indian pharmaceutical company Sun Pharma Global FZE.
The long-term solution remains challenging, but FDA Commissioner Dr. Margaret Hamburg said the agency had responded "actively and aggressively" to the immediate situation by assigning more staff.
She said President Obama's executive order on Oct. 31, which urged drug companies to speak up earlier with warnings of manufacturing problems, produced a sixfold increase in notifications. For all of 2011, she said, 195 shortages were prevented. Since the executive order, 114 problems have been prevented.
"We recognize the problem of drug shortages is complex and stems from an interconnected series of factors, including demand outpacing supply, maintaining high-quality manufacturing procedures and other economic and legal issues," Hamburg said. "Just as the problem isn't simple, there is no simple solution."
Children's Hospital of Philadelphia oncologist Peter Adamson was among the doctors urging Congress to pass long-stalled legislation requiring companies to notify the FDA of problems.
In the case of these two drugs, there was a connection. Ben Venue Laboratories' plant in Bedford, Ohio, produced both drugs before it was shut for manufacturing problems.
