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Congress Passes 21st Century Cures Act, Bringing Forth New Era for Biomedical Innovation

Wednesday, December 7, 2016   (0 Comments)
Posted by: Tara-Ann Coleman
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Congress Passes 21st Century Cures Act, Bringing Forth New Era for Biomedical Innovation

December 7, 2016

WASHINGTON, DC — FasterCures, a center of the Milken Institute, commends the U.S. Senate on today’s strong, bipartisan support of the 21st Century Cures Act (H.R. 34), which passed the Senate on a 94-5 vote, matching the U.S. House of Representatives’ vote of 392-26 on Nov. 30. The bill will now be sent to the White House. In last Saturday’s weekly address, President Barack Obama said that he would sign the bill into law as soon as it reaches his desk, enacting $4.8 billion of new funding for the National Institutes of Health (NIH) and $500 million for the Food and Drug Administration (FDA), as well as a comprehensive suite of policy provisions that will strengthen the entire biomedical innovation system.

“This landmark legislation will accelerate cures for many life-threatening diseases and help advance precision medicine,” said Michael Milken, chairman of the Milken Institute. “It assures patient-focused drug development, adds rigor to clinical trials, expands compassionate use of new drugs by dying patients, speeds the review of vaccines, addresses antibiotic resistance, responds to the opioid crisis and strengthens the nation’s research infrastructure.”

FasterCures has been honored to work with leaders in Congress, NIH and FDA throughout the bill’s journey. This is the culmination of more than two years of hard work and dedication by the bill’s bipartisan congressional champions and their staffs. House Energy and Commerce Committee Chairman Fred Upton and Representative Diana DeGette, with Ranking Member Frank Pallone, reached out to stakeholders throughout the medical research system to gather up the best ideas and translate them into legislation. Senate Health, Education, Labor and Pensions Chairman Lamar Alexander and Ranking Member Patty Murray also championed the effort and moved a set of bipartisan bills through their committee.

As the bill moved toward votes on the floors of both chambers, strong commitment from Speaker Paul Ryan, Majority Leader Kevin McCarthy and Democratic Leader Nancy Pelosi, in partnership with their Senate colleagues, Majority Leader Mitch McConnell and Democratic Leader Harry Reid, resulted in the overwhelmingly bipartisan votes we’ve seen in the past few days. Improving the biomedical innovation system is truly something that all can agree on.

“The time for medical research progress is now. We are so pleased that Congress seized this opportunity and united around this strong legislation,” said Margaret Anderson, executive director of FasterCures. “This act will invest in and strengthen the federal research system, which will support the United States’ long-standing tradition of scientific progress and hopefully spur advances for the many patients who are desperately waiting for effective treatments and cures.”

The 21st Century Cures legislation addresses the entire biomedical innovation system, and would support many of the recommendations from FasterCuresRx for Innovation project. Here are just a few examples from this comprehensive legislation:

  • Enhances patient centricity in biomedical product development and regulatory approval.
  • Bans efforts to block data sharing between health information systems, and provides the Department of Health and Human Services the authority to levy civil penalties against offenders.
  • Reforms FDA hiring authorities to fill the agency’s vacancies by enabling it to compete more effectively with industry to hire and retain the best and brightest experts to review medical product applications.
  • Expands the translational work done by the NIH’s National Center for Advancing Translational Sciences.
  • Catalyzes innovation in clinical trials and regulatory approval, without diminishing FDA’s authority to determine what constitutes a safe and effective medical product.

The new funding for NIH will provide $1.5 billion for the Precision Medicine Initiative, $1.8 billion for the Beau Biden Cancer Moonshot and $1.5 billion for the Brain Research through Advancing Innovative Neurotechnologies® (BRAIN) Initiative. All of these initiatives have the potential to significantly advance our understanding of disease and identify opportunities for new therapies.

FasterCures looks forward to working with Congress, the Obama administration and the incoming Trump administration to help implement the 21st Century Cures Act, realizing its promise to support scientific breakthroughs, translate those discoveries into medical products and deliver those treatments and cures to the patients who need them. There are approximately 10,000 diseases and 500 treatments; even with today’s vote, we still have work to do.


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