publication date: Feb. 21, 2014


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By Conor Hale

FDA needs to improve its access to data if it is to manage drug shortages more effectively, the Government Accountability Office concluded.

The FDA’s management of drug shortage data is “inconsistent with federal internal control standards,” the GAO report states.

“For example, FDA has not created policies or procedures governing the management of the data and has not conducted routine analyses using these data. Such shortcomings could ultimately hinder FDA’s efforts to understand the causes of specific shortages as well as undermine its efforts to prevent them from occurring.”

The GAO report, titled “Drug Shortages: Threat to Public Health Persists Despite Actions to Help Maintain Product Availability,” suggests that FDA build a new system to better wield the information they receive from private manufacturers.

The report was completed as part of a requirement of the Food and Drug Administration Safety and Innovation Act passed in 2012, the law which increased FDA’s authority to respond to drug shortages.

Overall, GAO found that while the number of new cases has slowed, the total remains high—and the watchdog agency delivered a few recommendations.

Appearing at a hearing of the House Committee on Energy and Commerce Committee Feb. 10, Marcia Crosse, director of the GAO’s health care team, noted a downward trend in the number of new shortages beginning in 2012—a trend which continued through 2013, based on partial data from that year.

“However, while the number of new shortages has begun to decline, the total number of shortages active during a given year—including both new … Continue reading 40-08 Capitol Hill

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