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Friday
Sep232011

US Drug Shortage Could Threaten US Health System

Comstock/Thinkstock(WASHINGTON) -- A growing shortage of important chemotherapy drugs, anesthetics and antibiotics, which has compromised or delayed care for some U.S. patients and may have led to at least 15 deaths, represents a "pressing public health problem," a top federal health official said Friday.

At the same time, shortages of medications to treat cancer and infectious diseases have strained, disrupted or derailed hundreds of important research trials within the National Institutes of Health, said Dr. Howard K. Koh, assistant secretary of the Department of Health and Human Services. He called the disruptions "very troubling to us as a nation that prides itself on scientific advances."

Koh painted a picture for the House Energy and Commerce Subcommittee on Health in which even the Food and Drug Administration, the federal agency responsible for assuring the safety of the U.S. drug supply, has been caught unaware when particular drugs have become scarce -- or impossible to get. "Oftentimes, the FDA does not know until it is too late, and then patients are stuck in this dire situation, and that's just not acceptable," Koh told lawmakers.

"We still have a large percentage of actual shortages where we were not aware that it was coming," Dr. Sandra Kweder, deputy director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research, told the panel.

One possible solution to the problem would be to find a way for manufacturers "to report impending supply disruptions and discontinuation of drugs," Koh said. "The sooner FDA learns of a drug shortage, the more effective it can be in helping to notify providers and minimizing the impact on patients."

The FDA doesn't have the power to require companies to report impending shortages. However, the proposed Preserving Access to Life-Saving Medications Act would give the agency the authority to require advance notification from drug manufacturers when life-saving drugs are in danger of becoming unavailable. The American Cancer Society Cancer Action Network, an affiliate of the American Cancer Society, Friday announced its support for the legislation.

As of Friday, 209 drugs were on the current shortage list compiled by the American Society of Health-System Pharmacists, based in Bethesda, Md., and some of them are the heaviest-hitters in cancer treatment and the battles against increasingly drug-resistant antibiotics.

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