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FDAäó»s Contribution to the Drug Shortage Crisis: Congressional Report
Darrell Issa (ed)
American patients and doctors 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 a Congressional Comm. shows that the crisis was largely sparked by actions of the Food and Drug Admin. (FDA). The Comm. learned that FDA regulatory activity has effectively shut down 30% of the total manufacturing capacity at four of Americaäó»s largest producers of generic injectable medications. The drug shortage crisis began in 2010 shortly after Margaret Hamburg became FDA Commissioner. 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. Contents of this report: Extent of the Drug Shortage Crisis; Economics of Shortages; Growing Market Concentration Laid the Groundwork for the Drug Shortage; FDAäó»s Role in Causing the Drug Shortages; Conclusion; Recommendations. Figures. This is a print on demand report.
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