Medical innovation bill stalled by funding

In one of the major bipartisan accords of the year, the House in July passed the 21st Century Cures Act, a bill that overhauls the drug and medical device approval process with the aim of speeding innovation and finding faster cures for diseases.

The bill won House approval by an overwhelming 344 to 77, with lawmakers on both sides of the aisle backing it.

The bill, Democratic caucus Chairman Xavier Becerra, D-Calif., said at the time, “gives us a fighting chance to achieve those breakthrough discoveries or life-saving treatments in time to reach your loved one or mine.”

But in the Senate, lawmakers have hit the “pause” button on the Cures Act.

Congress is poised to adjourn for the year, and the legislation is nowhere to be found on the Senate schedule.

The bill proponents hoped would accelerate medical miracles will have to wait until next year, at the earliest. Senators say that rather than taking up the House-passed Cures legislation, they are working on their own version.

“It’s a separate but parallel effort,” a spokesman for the Health, Education, Labor and Pensions Committee told the Washington Examiner.

One distinct difference will be funding.

The House-passed legislation drew most of its funding from the sale of the nation’s strategic petroleum reserve. But Republican and Democratic leaders have decided to use the reserve to pay for additional domestic and military spending instead.

“That pay-for was used,” Majority Leader Kevin McCarthy, R-Calif., acknowledged last week, when asked about the funding. “But, there are a lot of pay-fors out there.”

Senators are now searching for other ways to fund the legislation.

Sen. Lamar Alexander, R-Tenn., had signaled he could be finished with draft legislation by the end of this year, but as the congressional calendar winds down, that’s looking less likely. Alexander’s panel has been consumed with a major legislative re-write of the unpopular “No Child Left Behind” law, which cleared Congress just last week.

The Cures legislation could be difficult to pass when Congress returns in January because 2016 is an election year. Congress typically tackles few if any significant bills in even-numbered years, when a majority of lawmakers are up for re-election. When a presidential election is looming, legislative accomplishments are even more sparse.

Alexander’s committee also includes two senators running for president, Rand Paul, R-Ky., and Bernie Sanders, I-Vt., which could complicate efforts to come to a bipartisan agreement on a Cures measure.

And there is some opposition to the legislation. Among the critics are some who believe the measure’s streamlined process for Food and Drug Administration approval of medicines and medical devices would cut safety protocols and harm patients.

But Alexander is nonetheless optimistic about finishing the bill in the next session of Congress.

“It’s fair to say I think this is a train that will actually get to the station,” Alexander told the Bipartisan Policy Center.

Alexander said he believes cooperation from Democrats so far, coupled with interest from President Obama, will help the Senate overcome the typical partisan hurdles that often block significant reform legislation.

Alexander met this summer with President Obama, who told him he wants to find an avenue for enacting his Precision Medicine Initiative, which seeks to use medical innovation that takes into account genetic, environmental and lifestyle factors.

Obama proposed spending $215 million on the initiative in his 2016 budget proposal, which Congress did not enact.

Alexander said he told Obama he’d get the initiative funded in his bipartisan Cures proposal, a move that will attract bipartisan support and help ensure a presidential signature.

“The president,” Alexander told the Bipartisan Policy Center, “is interested in what we do.”

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