'Uncertainty' Remains Over Supply of Key Cancer Drugs

While shortage of generics has eased, more must be done to prevent future shortfalls, experts say

June 4, 2012 RSS Feed Print

According to Kweder, the FDA, in close consultation with drug companies, has already prevented about 150 drug shortages since October of last year, when President Barack Obama signed a special Executive Order demanding action on the issue. As companies gave FDA early warning of looming problems, the agency and the pharmaceutical industry worked together to find alternate sources of supply, including imports from abroad, Kweder said.

Methotrexate, the drug needed by children with leukemia, "continues to be very carefully monitored," Kweder said. "We expect the [shortage of] the injectable that has been difficult for some practices to obtain to be resolved within the next month completely."

Progress is taking place at the Congressional level as well, the experts said, as a bill makes its way through the House and Senate that would mandate that generic drug makers give the FDA six months advance notice of any possible production problems.

The bill, which has the full support of ASCO, also includes a provision that generics makers would pay the FDA a user fee, aimed at speeding oversight and approval for new generics.

All of this gives some comfort to Mahan, whose cancer has progressed but is being held in check by a new course of therapy. Still, he worries about other patients who may be facing the same dilemmas he did.

"Until this impacts you personally," he said, "most people aren't even aware that there's even a shortage going on."

More information

Find out more about the shortage of cancer medications at the U.S. Food and Drug Administration.