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Capitol Health Call
August 8, 2012

FDA Role in Drug Shortages

JAMA. 2012;308(6):558. doi:10.1001/jama.2012.8914

A report from the House Committee on Oversight and Government Reform suggested that improper regulatory activities by the Food and Drug Administration (FDA) are the primary reason for the severity of the ongoing drug shortage crisis (http://tinyurl.com/7fpop95).

The report, issued June 15, claimed FDA regulatory activity has effectively shut down 30% of the total manufacturing capacity at 4 of the United States' largest producers of generic injectable medications. Of the 219 drugs listed on the American Society of Health System Pharmacists' shortage list as of February 21, at least 128 (58%) were produced by at least 1 facility undergoing FDA remediation, the report noted. The report's authors said that the drug shortage crisis began in 2010 shortly after Margaret Hamburg, MD, became FDA commissioner and that since then, the FDA has failed to ensure that enforcement and compliance activities are conducted in a manner that does not create unnecessary shortages of critical drugs.