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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 add more staff to its drug-shortage office, the order stated.

The order also calls on the FDA to work with the U.S. Department of Justice to see if "gray market profiteers are hoarding drugs and charging exorbitant prices," said Sebelius.

"In past months we've heard of blood pressure drugs which are normally sold for $26 being sold for $1,200," she said.

Experts said the executive order is a good start, but that more is needed.

"This is a step in the right direction, but there's still much more to be done," said Dr. J. Leonard Lichtenfeld, deputy chief medical officer of the American Cancer Society. "We think the shortage issue is very serious. It's a major issue and it's disrupting patient care."

Another expert agreed. "I think this will help . . . [but] I still think there are some fundamental contributing factors that eventually will have to be addressed," added Dr. James Speyer, medical director of the Clinical Cancer Center at NYU Langone Medical Center in New York City.

Many of the scarce drugs are injectables, such as cytarabine and cisplatin, used to treat serious conditions such as cancer.

And most of the drugs are generic, meaning companies don't make much money on them and may, in some cases, opt to discontinue them.

The shortages occur frequently because of manufacturing problems, ranging from contamination to late delivery of raw materials. Other difficulties include label and packaging misprints and increased demand.

Some people believe FDA practices contribute to the shortages. For instance, critics say that if a plant is closed because of contamination, the FDA needs to speed up inspection of the facility to allow them to start producing the drug again.

More information

For more information on drug shortages, visit the U.S. Food and Drug Administration.

SOURCES: J. Leonard Lichtenfeld, M.D., deputy chief medical officer, American Cancer Society; James Speyer, M.D., medical director, Clinical Cancer Center, NYU Langone Medical Center, New York City; Oct. 31, 2011, teleconference with Kathleen Sebelius, Secretary, U.S. Department of Health and Human Services; Margaret Hamburg, M.D., commissioner, U.S. Food and Drug Administration; Jay Cuetara, patient, San Francisco


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