The US Senate passed the Food and Drug Administration (FDA) Safety and Innovation Act (FDASIA) on 24 May, advancing the bill for an eventual merger with the House of Representatives' parallel legislation.
The bill, which would fund FDA through a series of user fee agreements between FDA and regulated industry, was approved with near-unanimous consent. Only Sen. Bernie Sanders (I-VT) voted against the legislation.
The Congressional Budget Office (CBO) provided a boost to the Senate bill on 24 May, saying the bill will reduce the federal deficit by more than $350 million dollars over the coming decade.
The Senate voted on a number of amendments to the bill, defeating the overwhelming majority of them, including one to allow for the importation of drugs from Canada sponsored by Sen. John McCain.
Ten amendments ultimately made it into the bill, including ones to give FDA whistleblowers additional protections, require additional studies and reports, improve FDA's communication of risk and ban synthetic "cannabamimetic" substances.
The House of Representatives must now vote on a similar piece of legislation, the FDA Reform Act (FDARA), which Reuters reports could come as soon as the week of 28 May. CBO has found the FDARA legislation would increase the deficit by more than $244 million over the coming decade, which could complicate its passage in the House.
Food and Drug Administration (FDA) Safety and Innovation Act (FDASIA)
Congressional Budget Office - Budget Impact of FDASIA
Congressional Budget Office - Budget Impact of FDARA
Reuters - U.S. Senate passes bipartisan FDA funding bill
FDA Law Blog - U.S. Senate Slogs Through Amendments and Passes FDA Safety and Innovation Act; Onward to the House Bill
Politico - FDA user fee bill passed by Senate
The New York Times - Senate Backs Bipartisan Bill to Speed Drugs and Avert Shortages
Med Page Today - Senate Passes Drugmaker User Fee Bill
Bloomberg - FDA Gets Senate Approval for $6.4 Billion Review Fee Plan
The Hill - Senate passes FDA reauthorization
The Pink Sheet Daily - Senate Passes User Fee Package With Ease
PMLiVE - US industry welcomes Senate backing for PDUFABioWorld - PDUFA Passes Senate, Now Awaits Debate on House Floor