Regulatory Focus™ > News Articles > GAO Report Finds That FDA Needs Increased Authority to Address Shortages

GAO Report Finds That FDA Needs Increased Authority to Address Shortages

Posted 19 December 2011 | By

A Government Accountability Office (GAO) report released on 15 December, 2011 finds that the US Food and Drug Administration (FDA) needs increased authority in order to address the growing problem of drug shortages.  In her statement before the Senate Committee on Health, Education, Labor, and Pensions, GAO Director of Health Marcia Crosse stated that according to the Report, FDA is currently "constrained in its ability to protect the public health from the impact of [drug] shortages." The Report cites a 200 percent increase in drug shortages between 2006 and 2011.  The 196 shortages reported in 2010 represented a record number for one year, and 2011 is on-pace to surpass that record, with 146 shortages reported as of June, 2011. 

GAO reports that the average duration of a drug shortage between 2006 and 2011 has been 286 days, or approximately 9 months.  Moreover, industry appears to be taking steps to address the problem independently.  While the Preserving Access to Life-Saving Medications Act of 2011 (S. 296, H.R. 2245) remains pending in committee, FDA announced the December 19th publication of an interim final rule to make better use of its existing shortage-related authority under the Federal Food, Drug, and Cosmetic Act. (FDA Law Blog)

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