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House Committee Approves FDA User Fee/Drug Shortage Legislation

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The U.S. House Energy and Commerce Committee unanimously approved legislation containing provisions aimed at mitigating the ongoing prescription drug shortages affecting hospitals and health systems and the patients they serve.

The bill would reauthorize the U.S. Food and Drug Administration’s (FDA) authority to collect user fees for pharmaceuticals and medical devices.  It would require manufacturers to provide early notification to FDA of pending shortages, enable FDA to expedite applications for manufacturing changes for drugs in shortage, and improve FDA’s recordkeeping related to drugs in shortage, among other provisions.  These provisions will not solve the drug shortage crisis, but may alleviate current and future shortages.

Similar legislation was approved by the Senate Health, Education, Labor, and Pensions (HELP) Committee last month. The House and Senate versions contain few major differences, and both are expected to receive floor votes as early as next week.  HANYS strongly favors passage of these bills and is urging members of the New York Congressional Delegation to support them as they move forward. Contact:  Chelsi Stevens

Published May 14, 2012