Track-and-Trace Is Out! Senate and House's Final Version of PDUFA Excludes Track-and-Trace Provisions

The United States Senate and House of Representatives have passed Senate Bill 3187, also known as the “Food and Drug Administration Safety and Innovation Act.” Notably, SB 3187 would reauthorize the Prescription Drug User Fee Act (PDUFA), and permit the federal Food and Drug Administration to collect fees from pharmaceutical companies seeking FDA approval of new drugs and biologics.

 

While the introduced version of SB 3187 included a provision creating track-and-trace requirements for drug manufacturers and wholesale distributors, these provisions were not included in the passed version of SB 3187.

 

SB 3187 will be sent to the President Obama for consideration.

 

To view the passed and enrolled version of SB 3187, please click on the following link:

http://www.gpo.gov/fdsys/pkg/BILLS-112s3187enr/pdf/BILLS-112s3187enr.pdf.