User Fee Bill Delayed in Senate as Cloture Vote Forced
The long-running and surprisingly quick saga of the Food and Drug Administration Safety and Innovation Act (FDASIA) may have just encountered its first, albeit minor, setback.
Senate Majority Leader Harry Reid (D-NV) said he was forced to set up a procedural vote for Monday, 21 May after apparent disagreement emerged over which amendments would be permitted to be debated, reports The Hill.
The 21 May vote will be to end debate on FDASIA, otherwise known as cloture.
The setback comes after Reid gave impassioned remarks regarding his personal stake in the user fee legislation, which would empower the US Food and Drug Administration (FDA) with additional tools to fight drug shortages.
"As most senators know, my wife has been ill with cancer. And she had 20 weeks of chemotherapy," Reid said on the Senate floor. "Every week, we were worried that that drug wouldn't be there on that Monday morning… when she got those treatments."
Politico reports the procedural hang-up likely has to do with the "track-and-trace" system aimed at preventing counterfeit medications from entering into the supply chain, but The Hill noted Reid failed to specify which amendments or Senators were to blame for the delay.
The measure will now be subject to a motion to end debate on Monday, 21 May, with a final vote likely to occur on Wednesday, 23 May. The bill would then need to have its differences with the House's version worked out in a Conference Committee, at which time it would return to the Senate for a second and final round of votes before going to President Obama for his signature.
The White House indicated on 17 May it "strongly supports" the Senate's version of the legislation, but made no statement on whether it similarly supports the House's version of the legislation. The FDA Reform Act, the House's version of FDASIA, shares many of the same provisions.
Read more:
The Hill - Reid sets procedural vote Monday on FDA bill
The Hill - Reid notes wife's battle with cancer as Senate starts work on FDA bill
Politico - User fee bill may hinge on drug tracking system
Regulatory Focus - White House Throws Support Behind Senate User Fee Bill