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US House of Representatives Passes 21st Century Cures Act

XTALKS VITALS NEWS

House of Representatives

If the bill is passed in the Senate – and it’s expected to – the National Institutes of Health will receive an additional $4.8 billion in medical research funding.

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December 2, 2016 | by Sarah Hand, M.Sc.

In a 392 to 26 vote, the US House of Representatives have voted to pass the 21st Century Cures Act. If the bill is passed in the Senate – and it’s expected to – the National Institutes of Health (NIH) will receive an additional $4.8 billion in medical research funding.

The funding is set to be released over the next 10 years, with the majority of the money to go to three expansive science initiatives – the Precision Medicine initiative, the BRAIN initiative and the cancer moonshot – which were all established during the Obama administration. US states would also receive $1 billion to use to control the opioid crisis, and $500 million has been earmarked for the US Food and Drug Administration (FDA).

“We are on the cusp of something special — a once-in-a-generation opportunity to transform how we treat disease,” said Representative Fred Upton. “With today’s vote, we are taking a giant leap on the path to cures.”

While Upton and other proponents of the bill are encouraged by its overwhelming support in the House, some are concerned that the measures laid out in the act meant to speed the approval of prescription drugs, could undermine the FDA. In particular, the nonprofit group Public Citizen, is concerned that the bill’s requirements for the FDA to allow data summaries – as opposed to comprehensive clinical trials results – for new drug applications could compromise safety standards.



Other opponents of the bill argue that the FDA already approves drugs and medical devices faster than regulators in other countries, therefore legislation aimed at further expediting this process is unnecessary. In addition, the 21st Century Cures Act would allow the FDA to accept real-world evidence when determining whether a medicine should be approved.

“The summary data could hide important information about the safety and effectiveness from the FDA scientist reviewing the data,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “I’m disappointed to see it.”

But for some, the bill’s movement through the House is a major win. In particular, patient advocates desperate for new treatments for rare, or under-researched diseases, hope that this funding could make a big difference.

“To all the families who brought their stories out of the shadows, that dared to share their sorrows, their hopes, their shattered dreams, today is a day of joy,” said Representative Tim Murphy. “And today is only possible, I say to all those families, because they dared to step forward.”


Keywords: FDA, NIH, Precision Medicine


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