President Obama Signs User Fee Bill

On July 9, President Obama signed S. 3187, the Food and Drug Administration Safety and Innovation Act, which reauthorizes FDA user fees for pharmaceutical products. The legislation is the latest reauthorization of the Prescription Drug User Fee Act (PDUFA), which passed the House and Senate last month. Beyond the user fee provisions, the bill also includes new policies to address drug shortages; increases penalties for counterfeiting drugs; provides a directive to establish interoperability standards for prescription drug monitoring programs; as well as includes additional requirements for studies on hydrocodone scheduling, online pharmacies and combating prescription drug abuse by government agencies.

The final package did not include pedigree or traceability standards for pharmaceuticals.


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