A top GOP senator wants to finish work on major legislation for new health cures by September, after failing to reach an agreement before Congress recesses for the summer at the end of the week.
Sen. Lamar Alexander, R-Tenn., said he expects the Senate to finish its work on the 21st Century Cures package in September when Congress returns from a seven-week recess.
“This could be the most important legislation Congress passes this year, and there’s no excuse for not finishing our work in September,” he said.
On July 10, 2015, House lawmakers cheered when they overwhelmingly approved legislation that included new funding for medical research and policies to accelerate development of new drugs and devices.
However, in the year since the House overwhelmingly passed the 21st Century Cures Act, the Senate has yet to hold a vote on it. While a package of 18 bills has made it out of committee, the measures won’t reach the Senate floor by the end of this week.
The biggest sticking point is funding for the National Institutes of Health, with lawmakers trying to reach an agreement on a one-time boost for the medical research agency.
Advocates who pushed heavily for the House and Senate packages acknowledge the difficulties of getting legislation to President Obama’s desk this year.
“I think the odds have always been tough. I think that they are steeper now,” said Ellie Dehoney, vice president of policy for research advocacy group Research America.
“But never say never,” she quickly added.
Rep. Fred Upton, R-Mich., who shepherded Cures through the House, is indefatigable about the bill’s chances to reach the finish line.
“The stars have clearly aligned for Cures over the last year. We are committed, the Senate is committed, and the administration is committed — 2016 is the year for Cures,” he said Sunday.
House Speaker Paul Ryan told Politico Playbook on Monday that Congress hopes to get Cures done by the end of the year.
“We’re making good progress on Cures,” he said. “We intend to work over the recess on Cures.”
Any legislation that comes out of the Senate would have to be reconciled in a conference with the House.
Congress returns in September but is only in session for a few weeks before leaving for an extended period due to the elections. Then a lame-duck session will run for a few weeks after the Nov. 8 elections.
The policies contained in the Cures package have wide bipartisan support and are geared toward improving the approval process for new drugs and devices.
But that sentiment hasn’t extended to some medical experts who are hoping Cures doesn’t get passed this year.
“The legislation, while containing some useful measures, is flawed. Instead of hastily agreeing to it, Congress should postpone consideration until 2017,” according to an article by three experts in the Health Affairs blog on Monday.
The experts want the legislation to be wrapped into must-pass legislation next year reauthorizing a user fee program for the Food and Drug Administration.
The article noted that some provisions in the bill would increase risks to patients because it would roll back safety standards for FDA approval. For instance, the group opposed a provision to speed up approval of certain breakthrough medical devices and allow new antibiotics to be approved using smaller clinical trials.
The House and Senate bills “essentially seek to speed up the approval process by relaxing FDA’s safety and effectiveness standards. And to make that more palatable, sponsors have attached the changes to increases in funding for the National Institutes of Health and the FDA,” according to the post that included authors from the National Center for Health Research, a nonpartisan think tank.
