Federal officials unveiled two strategies Tuesday to combat shortages in two critical cancer drugs that have threatened to leave some patients without treatment.
The U.S. Food and Drug Administration said shortages of the ovarian cancer drug Doxil and methotrexate, used to treat childhood leukemia, prompted the agency to take the emergency actions.
For Doxil, the FDA approved the temporary importation of a replacement drug, Lipodox, to end the shortage and meet patient and hospital needs in the coming weeks. For methotrexate, the agency has approved a new manufacturer to further bolster supplies and help avert shortages.
“A drug shortage can be a frightening prospect for patients and President Obama made it clear that preventing these shortages from happening is a top priority of his administration,” said FDA Commissioner Dr. Margaret A. Hamburg, in a statement. “Through the collaborative work of FDA, industry, and other stakeholders, patients and families waiting for these products or anxious about their availability should now be able to get the medication they need.”
In addition, the FDA issued draft guidelines for new drug industry regulations requiring advance notifications to the agency “of issues that could result in a drug shortage or supply disruption.”
Under FDA plans, Lipodox will be imported from an Indian manufacturer, Sun Pharma Global, as an alternative to Doxil, used to treat ovarian cancer, AIDS-related Kaposi’s sarcoma and multiple myeloma. FDA is also working with several firms to provide methotrexate, used to treat children with acute lymphocytic leukemia and osteosarcoma.
Doxil and methotrexate were among nearly 290 drugs facing shortages in the United States, according to FDA statistics.