U.S. Drug Shortage Could Threaten U.S. Health System

Sept. 23, 2011— -- 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 today.

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.

In the last 15 months, at least 15 patients have died either because the proper or preferred drug wasn't available, or because of complications with substitute medications, according to an Associated Press review of industry reports and interviews with nearly two dozen experts. In the worst of those cases, AP reported, nine Alabama patients on feeding tubes died and 10 others were harmed because the sterile premixed nutritional solution they would normally have received was unavailable and they instead received their nutrition from a hand-mixed batch that became contaminated by bacteria.

One possible solution to the problem would be to find a way for manufacturers "to report impending supply disruptions and discontinuation of drug," 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, today 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.

So far this year, the FDA streamlined a process so that five critically needed drugs unavailable from U.S. manufacturers could be imported temporarily from overseas, said Shelly L. Burgess, an FDA spokeswoman. "We can't always find a firm willing and able to import, but when we do, we evaluate the overseas drug and the facility it's made in to make sure FDA quality standards are met and that the overseas drug is safe for U.S. patients." One young patient at the NYU Langone Clinical Cancer Center this week received intrathecal thiotepa (chemotherapy injected directly into the spinal fluid) imported from Europe with FDA permission, said Dr. James L. Speyer, medical director of the center.