GAO says FDA can do more to stop drug shortages

The Government Accountability Office on Monday will fault the Food and Drug Administration for failing to take proactive steps to forestall drug shortages, according to testimony posted Friday on the House Subcommittee on Health website. FDA Deputy Director Dr. Doug Throckmorton is expected to testify.

The government's watchdog agency will release its second report on drug shortages as healthcare providers continue to scramble to obtain hard-to-find drugs while upholding standards of care. The FDA should “conduct periodic analyses using the existing drug shortages data base … to routinely and systematically assess drug shortage information, and use this information proactively to identify risk factors for potential drug shortages early,” GAO healthcare director Marcia Crosse is expected to testify.

The report will show that though the number of new drug shortages has fallen off in recent years, the number of ongoing shortages as of last June 30 remains high. Hundreds of drugs ranging from saline solution to generic injectable oncology drugs are in short supply at hospitals across the U.S. Some progress has been made to alleviate or prevent shortages of late, in part due to new regulations and laws that have gone into effect over the last year.

While the number of new drug shortages is declining—there were 195 new shortages in 2012, compared with 255 in 2011—the number of active shortages isn't improving. There were 261 ongoing drug shortages in 2012, up from 184 in 2011.

“The big problem is that we're seeing fewer shortages, but the number of ongoing shortages is high,” said Cynthia Reilly, director of the medication safety and quality division for the American Society of Health System Pharmacists.

The shortages have had a widespread impact on patient care and hospital operations. Obtaining scarce drugs can mean higher prices. It has also meant some providers have to change dosages, delay treatments, refer patients to other facilities and develop new supply chain and labor strategies to ensure care.

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