Upcoming Webinars Archived Webinars Training Vitals Host A Webinar About Get Updates Contact

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.

Share this!

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


| NEXT ARTICLE | MORE NEWS | BLOGS | VIDEOS | POLLS & QUIZZES | WEBINARS |

Share this with your colleagues!

MORE NEWS
Exclusion Criteria for Clinical Trials Poses Major Barrier to Patient Enrollment

August 17, 2017 - UT Southwestern researchers say that clinical investigators continue to increase the number of exclusion criteria, preventing more patients from participating in clinical trials.

Featured In: Clinical Trials News


Targeting Cellular Nitrogen Metabolism Could Offer a New Treatment for Pancreatic Cancer

August 17, 2017 - An enzyme involved in regulating the amount of nitrogen in the cell could be a new drug target for pancreatic cancer, according to researchers from Boston Children's Hospital and the Broad Institute of MIT and Harvard.

Featured In: Life Science News


Regeneron’s Drug for Respiratory Syncytial Virus Fails in Phase III Clinical Trial

August 16, 2017 - Biotechnology company Regeneron has announced it will not continue development of its antibody drug, suptavumab, after a failure in a Phase III clinical trial.

Featured In: Clinical Trials News


LEAVE A COMMENT
 
  
THE XTALKS VITALS INDUSTRY BLOG

One Patient’s Perspective on Clinical Trials

REGISTER FOR THESE WEBINARS

Planning and Conducting Trials of the Latest Immunotherapies


ISO 13485:2016 for Medical Device Manufacturers: Ensuring a Smooth Transition through Effective Preparation


Medical Devices: Reviewing Regulatory Changes in the US and EU


Moving Beyond Regulatory and Performance Metrics in Starting Clinical Trials


Copyright © 2016-2017 Honeycomb Worldwide Inc.