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Ducker Worldwide In The News: FDA moves to counter effects of consolidation, shutdowns on drug supply


By Jay Greene

The U.S. Food and Drug Administration issued an interim final rule late last month that requires pharmaceutical companies to report to the FDA all interruptions of drugs that are "life supporting, life sustaining, or intended for use in the prevention of a debilitating disease or condition."

More than 220 drugs were reported in short supply in 2011, three times more than in 2006, the FDA said.

Hospital pharmacists in Southeast Michigan have told Crain's that drugs in short supply include morphine, antibiotics, electrolytes, multi-vitamin injections, the antiviral drug foscarnet, pre-loaded epinephrine syringes for breathing problems, and norepinephrine, which is commonly used in emergency rooms and routinely for cardiac bypass surgery.

"Eighty percent of the shortages are in hospital-based drugs, and more than half of the shortages are sterile injectables, which have a higher standard for quality by the FDA," said Fred Brown, managing director of the health care practice at the Troy office of Ducker Worldwide.

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