The 21st Century Cures Act would speed the development of some drugs and medical devices, but some worry it might unintentionally compromise patient safety.

The 21st Century Cures Act would speed the development of some drugs and medical devices, but some worry it might unintentionally compromise patient safety.

Ron Cogswell/Flickr (CC BY 2.0)

Amid funding dispute, Senate biomedical innovation effort teeters ahead

The massive biomedical innovation bill that breezed through the U.S. House of Representatives last summer is moving through the Senate, albeit on much weaker tailwinds. In the first of three scheduled hearings, the Senate’s health committee today approved an initial set of bipartisan proposals aimed at speeding the discovery and development of new medical treatments. Lawmakers hope the bills can be combined into a companion to the House bill, known as 21st Century Cures.

This piecemeal approach, which Senate health committee chair Lamar Alexander (R–TN) laid out last month, signaled partisan tensions over certain proposals in 21st Century Cures, notably an $8.75 billion boost for the National Institutes of Health (NIH) over 5 years, which in the House proposal would consist of dedicated mandatory funding, not subject to the annual budget appropriations process and budget caps. (The House bill proposes selling oil from the Strategic Petroleum Reserves to create the needed revenue.)

Alexander has been resistant to that approach, together with Republican colleagues on the Health, Education, Labor and Pensions committee. Today he indicated that the NIH windfall isn’t off the table, and that he is personally “willing to consider using mandatory funds” to support five priority areas: President Obama’s precision medicine initiative, the recently announced cancer moonshot, the Brain Research through Advancing Innovative Neurotechnologies initiative, a system of grants for “big ideas” across NIH institutes, and support for young investigators. (Those first three programs are also priorities in President Obama’s 2017 budget request released today.) But he noted that any proposal would need to find that funding by reducing existing mandatory spending elsewhere. And because many Republicans on the committee are resistant to mandatory funding, Alexander said he will reserve the question of how to pay for an NIH increase for the debate on the full Senate floor.

Instead, the committee today approved seven less controversial measures, including a bill to create a “Next Generation of Researchers Initiative” within the NIH Office of the Director to promote early-career researchers—also a priority in the House bill—and another to ease regulatory requirements for drugs targeting rare genetic diseases by allowing their sponsors to rely on data from previous submissions to the U.S. Food and Drug Administration (FDA).

Those baby steps are encouraging to some. “There was a lot of holding of breath on the outside—are they actually going to start to put some stuff out?” says Margaret Anderson, executive director of FasterCures, a think tank in Washington, D.C. “Now that that’s happening, I think there’s a sense of momentum … and I get the sense that the committee’s not done putting forward bills.”

But some Democratic committee members are unwilling to save for later the issue of mandatory funding for NIH and FDA. “A handful of smaller targeted changes like we’re voting on today won’t get us where we need to be,” Elizabeth Warren (D–MA), told the committee today. She accused Republican lawmakers of diverting the conversation from research funding and trying to loosen FDA’s requirements for drugmakers at the expense of patient safety. “If Republicans are determined to gut [FDA] under the guise of improving it, then get ready for a fight on this,” said Warren, who pledged not to support any more “so-called ‘innovation’ legislation” until the committee reached a bipartisan agreement that includes guaranteed NIH funding.

Richard Burr (R–NC) heaped on the pessimism. “There’s not going to be an innovation bill,” he said. “I plan to write one, but I doubt there’s one that can get out of this committee.”

Despite the dark clouds, a preliminary agenda for the panel’s 9 March hearing includes discussion about “bipartisan legislation to modernize [FDA] and [NIH],” including ways to support both precision medicine and the cancer moonshot.

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