WASHINGTON — Dire shortages of two critical cancer drugs — shortfalls that
have threatened the lives and care of thousands of patients — should be resolved within weeks, federal drug officials said.

The two drugs are Doxil and methotrexate, and in both cases supplies in the United States are being bolstered by shipments from abroad. Shortages of scores of other drugs continue.

“We’re not out of the woods,” said Dr. Sandra L. Kweder of the Food and Drug Administration’s drug center. “But these two particular shortages have been very, very upsetting to patients and to us.”

Dr. Peter C. Adamson, chairman of the Children’s Oncology Group, which is financed by the National Cancer Institute, said he was pleased that the immediate threat of a methotrexate shortage had passed. “But this is at best a Band-Aid approach to the problem,” he said.

Shortages of both drugs developed when Ben Venue Laboratories temporarily closed its manufacturing facility in Bedford, Ohio, because it could not guarantee product safety.

In the case of Doxil, which is used to treat ovarian cancer, multiple myeloma and AIDS-related Kaposi’s sarcoma, the F.D.A. has decided to allow temporary shipments from India of Lipodox, which is similar to Doxil and is made by Sun Pharma Global.

And the pharmaceutical company Hospira is rushing 31,000 vials — enough to last the entire nation a month — of preservative-free methotrexate from its plant in Australia to the United States. Hospitals began receiving the drug, which is vital in the treatment of a common form of childhood leukemia, on Tuesday. The F.D.A. has also hastened the approval of an application by APP Pharmaceuticals to manufacture methotrexate, an application that has languished since 2010.

There is a years-long backlog of applications for new generic drugs at the F.D.A. because the government does not have the money to hire enough reviewers to analyze the applications or inspectors to visit the facilities, many of them abroad. The generic drug industry tired of waiting for Congress to fully finance the F.D.A.’s generic drug office and this year proposed providing the agency with $299 million in annual fees to finance the review process.

Dr. Kweder said the agreement on generic drug fees — part of a package of F.D.A. fee proposals that Congress is expected to consider in the coming months — should eventually help prevent some drugs from going into short supply.

The F.D.A. on Tuesday also released a lengthy list of instructions for drug companies to follow when their manufacturing of critical medicines is threatened. At least 180 drugs, a record number, have been in short supply at one time or another over the past year. President Obama issued an executive order last year that was intended to ameliorate the situation; it requires drug companies to alert the F.D.A. when potential problems threaten supplies. Legislation on the issue is also pending in Congress.

Source – NY Times