[Ip-health] New York Times: Foreign Shipments to Ease Shortage of 2 Cancer Drugs

Thirukumaran Balasubramaniam thiru at keionline.org
Tue Feb 21 07:21:30 PST 2012


http://www.nytimes.com/2012/02/22/health/policy/fda-approves-imports-amid-shortage-of-2-cancer-drugs.html?_r=1&hp

February 21, 2012
Foreign Shipments to Ease Shortage of 2 Cancer Drugs

By GARDINER HARRIS

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

The two drugs are doxorubicin 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 doxorubicin, known by the brand name 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, vital in the treatment of a common form of childhood leukemia, from its plant in Australia to the United States. Hospitals are set to receive the drug on Tuesday. The F.D.A. has also hastened 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 that 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 is also expected to release a lengthy list of instructions for drug companies to follow when their manufacture 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 required drug companies to alert the F.D.A. when potential problems threaten supplies. Legislation on the issue also is pending in Congress.

But the causes of the shortages are multiple.

Dr. Adamson called on the F.D.A. to create an advisory committee of experts from across medical disciplines to assess which drug shortages were most acute.

“Children are at such risk from drugs in short supply that it doesn’t give me a whole lot of comfort that we’ve moved past one or two of these shortages,” Dr. Adamson said. “What about the next one? And the one after that?”


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Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)

thiru at keionline.org



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