U.S. Senate Passes Omnibus FDA Reform Bill

Earlier this week, the U.S. Senate passed S. 1082, the “Food and Drug Administration Revitalization Act” (“FDARA”) by a vote of 93-1 (Sen. Bernie Sanders (I-VT) was the lone “nay” vote).  The bill is an omnibus FDA reform and user fee package that, among other things, reauthorizes the Prescription Drug User Fee Act (i.e., PDUFA IV).  The U.S. House of Representatives must now move forward on its version of the legislation.  Once the House bill is passed, any differences between the bills will be reconciled in conference committee.

A copy of the version of the bill passed by the Senate was published in the Congressional Record, and is available here.  Next week, FDA Law Blog plans to make a series of posts on various provisions of the bill.