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New drug shortages cut in half as industry notifications increase

FDA commissioner Margaret Hamburg highlights progress of drug shortage reporting program

SILVER SPRING, Md. — The number of new drug shortages has been halved as early notifications from manufacturers of potential shortages have increased sixfold, the commissioner of the Food and Drug Administration wrote Thursday.

In a statement posted on the agency's website to mark the six-month anniversary of an executive order by President Barack Obama designed to prevent shortages of critical drugs, FDA commissioner Margaret Hamburg wrote that the agency had prevented 128 shortages and saw 42 reports of new drug shortages, compared with 90 during the same period last year. Meanwhile, between the periods of January to October 2011 and November 2011 to April 2012, the average number of monthly notifications of potential shortages increased from 10 to 60.

"This data is a testament to how FDA exercises flexibility and discretion in much of our work on drug shortages and the importance of strong collaboration and constant communication with industry, health professionals and patients," Hamburg wrote.

Some highlights included the cancer drug methotrexate, supplies of which are currently meeting demand, with no further supply issues expected; and a response by the agency to a shortage of Johnson & Johnson's cancer drug Doxil (liposomal doxorubicin) that allowed temporary importation of another brand of the drug, Sun Pharmaceutical Industries' Lipodox, from India. When Hospira notified the FDA of a shortage of the surgical anesthesia drug propofol, the agency turned to another manufacturer and was able to increase supplies.

Still, some issues have remained, Hamburg wrote. These include the injectable cancer drug leucovorin, used to treat leukemia in children alongside methotrexate; the agency is working with Teva to produce additional shipments. Another drug, Lundbeck's chemotherapy Mustargen (mechlorethamine hydrochloride) has experienced shortages as well, but the company is planning to make it available again in August.

"Drug shortages remain a serious, complex problem, and the agency remains extremely concerned about all current and potential drug shortages, not just those that I mentioned," Hamburg wrote. "Our efforts require a multifaceted approach involving industry, regulators, payers and others."


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