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POLITICO – FDA user fee bill passes Senate, 92-4

POLITICO – FDA user fee bill passes Senate, 92-4


The Senate voted Tuesday to send the Food and Drug Administration Safety and Innovation Act to President Barack Obama, in what’s almost certain to be the last major health care legislation before the fall elections.

The vote was 92-4.

With the Supreme Court set to release its ruling on the Affordable Care Act on Thursday, the upper chamber approved the final FDA bill, which the House passed last Wednesday, capping a rare case of bipartisan cooperation in a mostly gridlocked Congress.

The leadership of the Senate Health, Education, Labor and Pensions Committee and the House Energy and Commerce Committee had urged swift action on the must-pass legislation in part to protect it from the political fallout of the high court decision.

But Sen. Richard Burr (R-N.C.) objected Tuesday to the pressure to pass the bill so quickly and mourned the loss of some of the provisions he had backed, including a prescription drug “track-and-trace” system.

“Why did it have to be done before the Supreme Court?” he asked, adding that “somebody started this as a goal and it was just adopted.”

HELP Chairman Tom Harkin (D-Iowa) patiently sat through about two hours of comments from Burr.

Harkin noted that earlier versions of the FDA bill passed the House unanimously, and the Senate by 96-1, and that the HELP Committee had worked for well over a year on the package before Burr and Sen. Michael Bennet (D-Colo.) introduced the track-and-trace amendment just one day before the committee’s filing deadline.

“Again, who is trying to rush what?” Harkin asked, noting the many stakeholders involved. He said he would continue to work toward a consensus, as they have done with the rest of the bill. “We have to build that coalition,” Harkin said.

The FDA Safety and Innovation Act will provide more than $6 billion in industry user fees to the FDA over the next five years to fund a share of the agency’s review of drugs and medical devices.