Peter Adamson of the Children's Oncology Group said Congress needs to step up and pass legislation to curb future drug shortages. (Safiya Merchant/Medill)
WASHINGTON – To counter the shortage of two important cancer drugs, the Food and Drug Administration reached out to U.S. and foreign manufacturers Tuesday in an attempt to increase the flow of the drugs to American markets and hospitals.
FDA Commissioner Margaret Hamburg said Tuesday her agency has chosen a foreign manufacturer to produce an alternative to Doxil, which is often used to treat ovarian cancers and AIDS-related Kaposi’s sarcoma. And to ease the shortage of Methotrexate, another drug that treats diseases like lung and breast cancer, the FDA has approved a preservative-free version from APP Pharmaceuticals for manufacture and distribution as early as next month.
“We stand ready to do all that we can, and to continue our collaboration with industry and other stakeholders so that patients have products that are not only safe and effective, but products that are there when they need them the most,” Hamburg said at the FDA’s announcement.
Doxil and Methotrexate were in short supply last year, according to Valerie Jensen, associate director for the FDA’s drug shortage program. Hospitals actually started running out of Methotrexate last week, she said.
To make up for the lack of Doxil, the FDA has arranged to temporarily import an alternative drug, Lipodox, from Sun Pharma Global FZE, an India-based pharmaceutical company with a distributor in Detroit.
The FDA said in a statement it has “prioritized review” of APP’s version of Methotrexate. APP’s medication is expected to hit the mass market in March.
Sandra Kweder, the deputy director of the FDA’s Office of New Drugs, said that when the agency expects a drug shortage, multiple steps are taken to ensure a continued supply for American patients. Some of these actions include urging the original manufacturers of the drugs to increase production, and looking to international vendors who make the same drug.
Besides finding new sources for the cancer drugs, the FDA also provided drug manufacturers Tuesday with new guidelines on when and how to inform the agency of any looming drug shortages.
The agency acted in response to President Obama’s Executive Order last October , when he urged the FDA to deal aggressively with future drug shortages.
Still, Peter Adamson, the chairman of the Children’s Oncology Group, said he thinks Congress also needs to act in order to prevent drug shortages. Adamson said Congress should approve passthe Preserving Access to Life-Saving Medications Act, which requires drug manufacturers to report any suspicions of shortages.
“I certainly understand that passing legislation is complex, it’s difficult. I suspect, however, that it is no more difficult than curing a child with cancer,” Adamson said. “And I can absolutely tell you that it is no more complex or difficult than what children every day face…in their fight against child cancer.”
