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Obama Acts to Ease U.S. Drug Shortages
Date:10/31/2011

By Amanda Gardner
HealthDay Reporter

MONDAY, Oct. 31 (HealthDay News) -- Jay Cuetara arrived at the chemotherapy suite of his hospital one day and was told a critical component of the chemo cocktail that had kept his metastatic cancer in check for two-and-a-half years was unavailable.

Cuetara, 49, didn't get treatment that day, but he still was one of the lucky ones: His San Francisco hospital managed to procure the drug and he resumed treatment in just one week. Others have been less fortunate.

Now, an executive order signed by President Barack Obama Monday may help ease the drug shortages that threaten the lives of patients like Cuetara across the United States.

The executive order directs the U.S. Food and Drug Administration (FDA) to "take action" to prevent and reduce the worsening prescription drug shortages that have plagued the country for several years.

"Between 2005 and 2010, the number of prescription drug shortages has tripled," said Kathleen Sebelius, secretary of the U.S. Department of Health and Human Services, at a Monday news conference.

So far this year, some 200 drug shortages have occurred compared to 178 in all of 2010, the FDA previously stated.

The executive order directs the FDA to take steps to require drug manufacturers to report any impending shortages or discontinuances six months ahead of the shortage, as recommended by pending bipartisan legislation.

Now, drug manufacturers only have a legal obligation to notify the FDA if they are discontinuing a drug for which there is just one manufacturer, FDA commissioner Dr. Margaret Hamburg said, speaking at the news conference. Other notifications are voluntary.

"The data is clear that early notification has a significant and meaningful impact on drug shortage," said Hamburg.

The FDA should also speed up its review of new manufacturing sites, new suppliers and new manufacturing protocols, and also
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