FDA Efforts Reversal of Critical Cancer Drug Shortage

February 21, 2012— -- The U.S. Food and Drug Administration approved new suppliers for two cancer drugs today in an effort to curb the largest nationwide drug shortage in nearly a decade.

The FDA said its approval of a new supply method would increase production of the injection form of the drug methotrexate, which is used to treat children with the most common form of childhood leukemia.

The agency also said it would allow temporary foreign imports of the cancer drug Lipodux, an alternative to the drug doxorubicin, which is used to treat ovarian cancer, multiple myeloma and AIDS-related Kaposi's sarcoma. Temporary foreign importation is a rare move for the agency.

"In different circumstances we have to apply different tools," said FDA Commissioner Peggy Hamburg in a statement, adding that the quality of the drug was evaluated by the agency before its temporary approval.

The FDA's actions follow President Obama's executive order issued in October 2011 to reduce the dire drug shortage. The order instructed the FDA to broaden its reporting of potential drug shortages, expedite regulatory reviews that can help prevent shortages and investigate whether potential shortages have led to price gouging.

The drug shortage has compromised or delayed care for some patients and may have led to otherwise preventable deaths, say many oncologists.

All five pharmaceutical companies that make the injection drug methotrexate, which treats acute lymphoblastic leukemia by slowing the growth of cancer cells, have either slowed or stopped manufacturing the drug, according to the FDA. The companies have blamed shortages on high demand and manufacturing delays.

Drug manufacturers APP Pharmaceuticals and Hospira Inc. announced at the press briefing Tuesday that within four to six weeks, both companies would have made enough methotrexate, including the preservative-free form, to meet the nationwide demand.

Next week Hospira plans to release 34,000 vials of methotrexate, or a month's supply of the drug, Michael Ball, CEO of Hospira Inc., told reporters at Tuesday's briefing.

According to Michael Link, a pediatric oncologist and president of the American Society of Clinical Oncology, some hospital pharmacies reported having only a couple of weeks of supplies left.

For two years, Sarah Stuckey's 6-year-old son, Nate, who has acute lymphoblastic leukemia, has been treated with methotrexate. After hearing about the nationwide drug shortage, Stuckey contacted her son's medical center.

"The head nurse said there was enough for Nate's next treatment, but after that I should be concerned," said Stuckey, who has since reached out to her congressman for help.

Many oncologists are especially worried about the shortage of the preservative-free form of methotrexate, which is considered less toxic.

Only the preservative-free methotrexate can be injected into the spinal fluid of cancer patients to prevent the spread and recurrence of the disease.

"There are couple other drugs that can be injected into the spinal fluid, but none that are as effective," said Link. "As for the high dose version of the drug, there's no workaround for it."