The U.S. Government Accountability Office found the number of drug shortages has increased substantially in recent years, and the FDA is limited in its ability to defend against the impact of these shortages, according to the GAO report.
The study found 1,190 reported shortages from Jan. 1, 2001, to June 20, 2011. A record number of shortages (196) were reported in 2010, and 2011 is expected to exceed that record, with 146 shortages reported as of June 20, 2011. The report also found the FDA has a limited ability to control, prevent and mitigate these shortages.
"Specifically, FDA is constrained by its lack of authority to require manufacturers to provide the agency and the public with information about shortages, or require that manufacturers take certain actions to prevent, alleviate, or resolve shortages," the report said.
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The study found 1,190 reported shortages from Jan. 1, 2001, to June 20, 2011. A record number of shortages (196) were reported in 2010, and 2011 is expected to exceed that record, with 146 shortages reported as of June 20, 2011. The report also found the FDA has a limited ability to control, prevent and mitigate these shortages.
"Specifically, FDA is constrained by its lack of authority to require manufacturers to provide the agency and the public with information about shortages, or require that manufacturers take certain actions to prevent, alleviate, or resolve shortages," the report said.
Related Articles on Drug Shortages:
ASA President Dr. Jerry Cohen "Pleased" by Release of GAO Drug Shortage Report
HSCA Commends Generic Pharmaceutical Association for Proposed Drug Shortage Solution
5 Proactive Measures for Anesthesiologists to Combat Drug Shortages