A major effort to get a biomedical research bill across the finish line in Congress has stalled, despite protestations of “momentum” for the far-reaching measure.
The House passed the 21st Century Cures Act nearly a year ago, and House leaders have continued to work for its passage in the Senate, but its efforts have been in vain. The bill seeks to hasten approval of new drugs and devices and provides new money for medical research.
The House Energy and Commerce Committee, which crafted the bill, has been pushing to keep the legislation in the public eye, continually sending out press releases touting momentum behind the bill.
“The momentum for Cures continues to grow — but there is a distinct urgency to this effort,” wrote committee Chairman Fred Upton of Michigan in a May 16 post on medium.com.
Since last year, the ball has been in the Senate’s court, with the Senate Health, Education, Labor and Pensions Committee opting to pass 18 bills that will act as the companion to cures.
HELP Chairman Sen. Lamar Alexander, R-Tenn., said recently on the Senate floor that he hopes to get a vote by July, which would be pivotal as Congress is taking a seven-week recess starting that month because of the party conventions.
A House Energy and Commerce spokesman told the Washington Examiner that the panel is working with the Senate on the bills, and that “an agreement can’t come soon enough for patients.”
But the bills have yet to reach the Senate floor, as Congress has been busy with other priorities, including opioid abuse, the Zika virus and the Puerto Rico debt crisis.
There are no updates on when the bills will hit the Senate floor, said Don Stewart, spokesman for Senate Majority Leader Mitch McConnell.
One Senate Democrat doubted if the Senate bills would reach the floor by the end of this year. “It’s a challenging year, both in terms of the political dynamic being a presidential and a congressional election,” said Sen. Bob Casey, D-Penn., in a Morning Consult report.
A major sticking point in the Senate has been new funding for the National Institutes of Health.
The House reached a major bipartisan agreement to give NIH nearly $9 billion over five years in new mandatory funding. That bipartisanship has been lacking in the Senate.
Senate Democrats pushed for $5 billion a year for the NIH in new mandatory funding. Alexander and other Republicans have balked at offering multiple years of mandatory funding.
“Sen. Alexander said that he believes the case can be made for one-time support for limited mandatory funding at the NIH for high-priority [projects] which have a beginning and end,” a Senate aide previously told the Examiner.
Another major problem is time.
Because it’s a presidential election year, Congress will recess for seven weeks in mid-July due to the party conventions and will leave Washington in mid-October in advance of the elections, not leaving much time to pass legislation. Then a lame-duck Congress will run out the clock for the rest of the year.
“The fact [is] that we are in an election year where 34 members of the Senate and all 435 [members of the House] could put this on the backburner,” said Brian Rye, an analyst for Bloomberg Intelligence, in a recent Bloomberg webinar.
Even if Congress doesn’t get to Cures this year, that may not spell the end for the effort to get biomedical legislation through Congress.
Congress does better when it has a deadline, which is lacking with the Cures initiative.
Rye noted that Congress has to reauthorize a user fee program for the Food and Drug Administration before it expires in September 2017. The FDA collects fees from drug and device makers and uses those funds to improve the regulatory approval timeline.
“Some of these provisions that they really want to move forward with could be tacked on to that [user fee] bill,” Rye said.
In the most recent reauthorization bill in 2012, only “one-third had to do with user fees,” he said.
