FDAs Contribution to the Drug Shortage Crisis, Committee on Oversight and Government Reform Report, U.S. House of Representatives, 112th Congress, June 15, 2012.
“American patients and doctors currently confront an unprecedented shortage of critical drugs. The widespread shortages are causing inferior treatment regimens, interruptions in care, higher health care costs, and even premature death. The drugs in shortage are mostly generic injectable medications, many of which have been on the market for decades. Although the shortages have been attributed to a myriad of factors from a lack of raw materials to increased demand, information obtained by the Committee on Oversight and Government Reform shows that the crisis was largely sparked by actions of the Food and Drug Administration (FDA). The Committee has learned that FDA regulatory activity has effectively shut down 30% of the total manufacturing capacity at four of Americas largest producers of generic injectable medications: Bedford Laboratories, Hospira Pharmaceuticals, Sandoz Pharmaceuticals, and Teva Pharmaceuticals. Of the 219 drugs listed on the American Society of Health System Pharmacists (ASHSP) shortage list as of February 21, 2012, at least 128 58% of the drugs on the shortage list were produced by at least one facility undergoing FDA remediation.”
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