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Drug Shortages Cut in Half in U.S. After New FDA Powers

New U.S. drug shortages have fallen by more than half this year after President Barack Obama gave regulators the power to head off potential scarcities, the head of the Food and Drug Administration said.

There have been 42 new shortages in 2012, compared with 90 at the same time last year, FDA Commissioner Margaret Hamburg said today on the agency’s website. Obama directed the FDA Oct. 31 to gather information earlier from drugmakers about potential shortages to help find alternate sources, increase production or start new manufacturing before patients’ lives are threatened.

“I am both amazed and delighted to see the progress that’s been made,” Hamburg said. “Early notification to FDA of potential disruptions in drug supply has made a huge difference in our efforts.”

The agency has used stopgap approvals to address some shortages, such as the importation of an Indian replacement for Johnson & Johnson’s Doxil, an ovarian cancer treatment. Hamburg said the FDA is now concerned about a short supply of anesthesia drugs, including benzodiazepines and fentanyl injections.

One anesthetic, Hospira Inc.’s propofol, was saved by early notification that allowed the FDA to work with other makers to keep the drug available for surgery patients, Hamburg said.

Before Obama’s executive order, the agency received an average of 10 monthly notifications of potential drug shortages from January 2011 to October 2011, according to the FDA. The number jumped to 60 from November to April. The agency prevented 128 shortages since Obama’s order, Hamburg said. The reporting on potential shortages is voluntary.

Drug shortages almost tripled to 178 in 2010 from 61 in 2005, according to an FDA report released in October. Sterile injectables account for 80 percent of the shortages the FDA studied, 28 percent of which were cancer drugs.

Manufacturing was the main reason in 43 percent of the cases reported to the FDA for shortages, the agency said.

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