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21st Century Cures Act Clears Senate Hurdle on the Way to Vote

The Senate is poised to pass the 21st Century Cures Act by the end of the week, opening opportunities for billions in precision medicine funding.

By Jennifer Bresnick

UPDATE: The Senate has passed the 21st Century Cures Act in a Wednesday afternoon vote with a 94-5 margin.  The legislation will now await President Obama's signature.

21st Century Cures Act for precision medicine

Senators are finished debating the long, tangled list of provisions included in the 21st Century Cures Act, and have voted 85-13 to end discussion on the legislation, which clears the way for an up-down vote by the end of this week.

The precision medicine funding and drug regulation package is expected to fly through the remainder of the legislative process and land on the President’s desk, despite lingering opposition from a few Senate members wary that the bill is too friendly to pharmaceutical developers.

In addition to providing $4.8 billion in funding for the National Institutes of Health (NIH), which is overseeing the Precision Medicine Initiative (PMI) and Vice President Biden’s Cancer Moonshot, the 21st Century Cures Act will allocate $1 billion to fight opioid abuse and will also fund mental health reform efforts.

But the bill also allows pharmaceutical developers to bypass certain aspects of the FDA’s regulation processes, which has raised concerns among patient safety advocates. 

READ MORE: FHIR Can Move Genomics from Prediction to Precision Medicine

Under the Act, which passed the House 392-26, pharmaceutical companies would be able to sell some medications for off-label uses.  Doing so allows manufacturers to skip over time-consuming safety procedures, including dedicated clinical trials and FDA approvals.

The FDA would also be allowed to approve new drugs for select conditions based on smaller trials of patients, and to use summaries of data to make decisions about the safety and efficacy of treatments.

Democratic Senator Elizabeth Warren of Massachusetts remains one of the only dissenting voices in the discussion, and has warned that the “tiny fig leaf of funding” for precision medicine, opioid abuse, and cancer research is obscuring the “huge giveaways to giant drug companies” included in the bill.

She also pointed out that much of the money allocated for research will need to go through Congressional approval each year, which could change the final amount that actually makes its way into research organizations.

However, both President Obama and Vice President Joe Biden have expressed extremely strong support of the legislation, and they are joined by the vast majority of lawmakers eager to get the Act signed by the end of a long and contentious legislative session.

READ MORE: NIH to Bring Precision Medicine Data Collection to Patient Homes

On Tuesday, Senate Finance Committee Chairman Orrin Hatch (R-UT), urged his colleagues to support the bill, which contains a number of provisions developed by several of his committees.

“This important legislation represents the hard work of members from both parties and from both sides of the Capitol and has support across the economic and ideological spectrum,” he said. 

“Put simply – or as simply as one can for a measure of this size – the 21st Century Cures Act represents a significant investment in improving our ability to discover and develop new treatments and medicines and ensure that patients have access to them.”

Vice President Biden joined the Senate on Monday for the procedural vote, the New York Times notes, as lawmakers agreed to rename a section of the bill after his son, Beau Biden, who died from cancer in 2015. 

Biden has demonstrated deep commitment to the Cancer Moonshot, which is working in conjunction with the Precision Medicine Initiative to discover new treatments, speed and expand research activities, and broaden patient advocacy and involvement in the cancer care community.

READ MORE: ONC Highlights Its Precision Medicine Initiative Collaborations

The funding opportunities included in the 21st Century Cures Act will help providers, researchers, and advocacy groups heed the call of “urgency” put forth by the Vice President in June at a summit held by Howard University.

“This isn’t about a single person,” Biden said at the time.  “It’s about us.  It’s about not giving up hope and having the urgency now.  These are breakthroughs that are just beyond our grasp.  I urge all of you to think beyond your comfort zone.”

“It’s not that we don’t know how to do it.  We’re just not urgently focused on what needs to be done.”

With several billions of dollars in funding prepped to flow after the legislation passes the last Congressional barriers, Biden and the precision medicine research community are likely to be able to move quickly to accelerate the progress of cancer care, genomics, and other personalized health issues.

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