Doctors urge more production of scarce cancer drug
The heads of the American Society of Clinical Oncology, American Cancer Society of Pediatric Hematology/Oncology and Children's Oncology Group, a nationwide network of researchers, wrote to top executives at four U.S. makers of the drug pleading for help.
The cancer groups urged the drugmakers to "take all necessary steps to rapidly increase access" to the preservative-free version of methotrexate, which is needed for children because the preservatives can be dangerous for them.
"Doctors and pharmacists are scrounging for supply with very little luck and are beginning to ration the remaining supply. It is not an understatement to say that this is creating a panic in the childhood cancer community," the letters state. Sen. Amy Klobuchar, D-Minn., sent a similar plea to the companies Monday evening.
"Families fighting childhood cancer should not have to worry about where they're going to get the next dose of the drug they need to save their child's life," Klobuchar wrote.
The letters went to APP Pharmaceuticals LLC, Hospira Inc., Sandoz Inc. and Mylan Inc.
An APP spokeswoman wrote that the company doesn't have FDA approval for a preservative-free product, but "over the next two weeks we will be shipping additional methotrexate" with preservative to customers across the U.S. Spokespeople at the other three companies did not have responses.
Klobuchar is the sponsor of a bill that would require manufacturers to notify the Food and Drug Administration immediately of impending shortages of key drugs - to give the FDA enough advance notice that it can take steps to prevent a shortage by working with other manufacturers.
The agency increasingly has been doing that and already is working to increase the supply of methotrexate, also used to treat rheumatoid arthritis.
Most of the medicines that have become scarce are sterile injected drugs that are the workhorses of hospitals and are normally inexpensive because they've long been available as generics.
The FDA says the main reason for the shortages is manufacturing deficiencies leading to production shutdowns.
Shortages also are resulting from companies halting production of drugs with low profit margins, companies consolidating in the generic drug industry and supplies of some ingredients shrinking.
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