GAO report, executive rule target drug shortages

Dec 15, 2011 (CIDRAP News) – The US Government Accountability Office (GAO) today said drug shortages tripled over the past decade while in related news the Obama administration announced steps to address the problem.

Marcia Crosse, PhD, the GAO's director of healthcare, presented a GAO report today during testimony on prescription drug shortages before the Senate Committee on Health, Education, Labor, and Pensions (HELP).

The GAO report said the pace of drug shortages this year is expected to exceed the record number reported in 2010. It recommended that Congress strengthen federal authority to respond to the shortages.

Meanwhile, the Obama administration issued an interim final rule today designed to help address drug shortages, which requires companies that are the sole producer of certain critical drugs to report all manufacturing interruptions to the Food and Drug Administration (FDA).

The GAO's review explores drug shortages that occurred between Jan 1, 2001 and Jun 20, 2011, finding a 200% increase during the time period. More than half of the drugs deemed critical were generic injectables, with anesthetic, oncology, and anti-infective drugs as the ones most often in short supply.

Of 15 drug shortages that the GAO took a detailed look at, 12 were linked to manufacturing issues, such as quality problems with sterile injectable drugs, which are made by fewer, aging facilities. Shortages were sometimes worsened by multiple problems.

The FDA has shown that it can it can help prevent drug shortages if it knows of them in advance, the GAO said. However, the FDA lacks authority to require manufacturers to notify it about potential or current shortages. The GAO urged Congress to establish a shortage-reporting requirement for manufacturers.

Senator Mike Enzi, R-Wyo., ranking member of the committee, said in a press release today that it's essential to move quickly to get crucial drugs to the patients who need them, and the FDA should do more to address the shortages.

"Congress must implement a solution that will not only mitigate shortages in the short term, but address underlying causes so we do not find ourselves in this tragic situation again," he said.

The interim final rule issued by the Obama administration follows an Oct 31 executive order that directed the FDA and the Department of Justice to take actions to reduce drug shortages, protect consumers, and prevent stockpiling and price gouging, according to a Department of Health and Human Services (HHS) press release.

The Administration has voiced its support for bipartisan legislation in the House and Senate that would require all drug shortages to be reported to the FDA and give the FDA new authority to enforce the requirement.

See also:

Dec 15 GAO report

Dec 15 US Senate HELP Committee press release

Dec 15 HHS press release

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