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RESEARCHERS CONCERNED BY INADEQUATE FDA RECALL NOTIFICATION SYSTEMS

RESEARCHERS CONCERNED BY INADEQUATE FDA RECALL NOTIFICATION SYSTEMS

Researchers say that the Food and Drug Administration's system of recall notifications is inadequate and may expose patients to defective pharmaceuticals long after a recall is issued.

ABC News reported on a study covering FDA notifications for the most serious drug recalls between 2004 and 2011. Researchers found that the agency issued official public notices for only about half of the 91 most urgent drug recalls deemed to expose patients to serious harm or death.

"The FDA offers this communication service, and we anticipate that a lot of providers may rely on it and in doing so may not be getting the information they need when drugs are recalled," a study author said. The study was conducted by epidemiologists at Brigham and Women's Hospital in Boston and recently published in the Archives of Internal Medicine.

The study found that in addition to not fully publicizing all recalls of dangerous pharmaceuticals, the FDA cluttered its two main notification systems with things like veterinary drug recalls that did not impact patient care.

"It's very possible that these important recalls are being lost in the less important ones," a study author said.

An FDA spokeswoman told ABC News that it uses many ways to communicate recalls to health care providers and consumers. The spokeswoman added that it is also the responsibility of pharmaceutical companies to inform the public of recalls.

"The recall system depends on full and open disclosure by manufacturers, trust and the industry's acceptance of its responsibilities to protect the public from violative products," the spokeswoman said.

Source: ABC News, "U.S. Has Drug Recall Problem, Study Says," Carrie Gann, June 4, 2012

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