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U.S. Senate Takes Up FDA User Fee Reauthorization

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Full U.S. Senate consideration of legislation to reauthorize U.S. Food and Drug Administration (FDA) authority to assess user fees on prescription drugs and medical devices began yesterday. The legislation has broad, bipartisan support and contains provisions aimed at ameliorating current and future prescription drug shortages.

HANYS supports the legislation as an important step toward mitigating current and future shortages.

The Senate will likely consider a discrete number of amendments during floor consideration, including one filed by Senator Richard Blumenthal (D-CT) that would impose fines on pharmaceutical manufacturers that fail to report expected shortages of critical drugs.  The bill would require early notification but would not assess penalties. 

A number of senators continue to work to reach agreement on language related to the establishment of a national drug tracking system.  

Similar legislation is expected to be taken up by the U.S. House of Representatives shortly after it returns from recess.

HANYS is urging members of the New York Congressional Delegation to support the FDA user fee reauthorization bills in both houses.  Contact: Chelsi Stevens

Published May 23, 2012