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House Passes Final FDA User Fee Legislation Including Drug Shortage Provisions

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Yesterday, the U.S. House of Representatives approved in bipartisan fashion legislation to reauthorize for five years the U.S. Food and Drug Administration’s (FDA) authority to assess user fees for prescription drugs and medical devices.  HANYS supports provisions aimed at ameliorating prescription drug shortages. The Senate is expected to approve the bill next week and President Obama is expected to sign it into law soon after.

Among the drug shortage provisions included in the bill are early shortage notification requirements for drug manufacturers, expedited FDA approval of manufacturing changes that would help prevent or mitigate shortages, and improved public recordkeeping of drug shortage lists. FDA would also be required to issue updated guidance on repackaging, which could modify current practices to allow hospital systems to share shortage drugs among facilities.

The legislation does not include measures to establish a national drug tracking system, a proposal that had been discussed, but on which House and Senate negotiators were unable to reach consensus.

The Congressional Budget Office estimates the bill will reduce federal budget deficits by $311 billion over ten years.  Contact: Chelsi Stevens

Published June 21, 2012