12.07.16

Senate Passes 21st Century Cures Legislation, Includes Key Health Care Innovation Bills Championed by Burr

WASHINGTON – Today, the Senate passed the 21st Century Cures Act by a vote of 94-5. The bipartisan legislation includes several health care provisions written by Senator Richard Burr (R-NC) as well as $4.8 billion in targeted funding for the National Institutes of Health to accelerate key research initiatives, including the Precision Medicine Initiative and the Vice President’s Cancer Moonshot.  The 21st Century Cures Act also provides $1 billion to help states combat our nation’s tragic opioid abuse epidemic.

“This landmark legislation sends the unequivocal message that the United States has never been more serious about leading the world in medical innovation,” said Senator Richard Burr.  “As our nation ushers in a new and defining era of medical discovery and development, it is critical that we seize this opportunity to better serve Americans battling devastating diseases. This bill will not only spur the innovation that will save and improve lives, but better prepare us for the serious health care challenges and threats we face.   While our work on these issues will never be done, the Cures bill offers great hope to so many by supporting those on the front lines of discovering, developing, delivering, and defining quality health care for years to come.”

The following Burr bills are included in the 21st Century Cures Act:

Advancing Breakthrough Devices for Patients Act– This legislation builds on the Advancing Breakthrough Therapies for Patients Act, which the Senate passed in 2012 from Senators Michael Bennet (D-CO), Orrin Hatch (R-UT), and Burr. This legislation will ensure an “all-hands-on-deck” approach to devices, while also complementing and enhancing the existing tools, such as priority review, currently in place for devices, with the goal of expediting the development and review of breakthrough products. Senators Michael Bennet and Orrin Hatch are original cosponsors of this bill.

FDA Device Accountability Act – This bill ensures that the FDA eliminates unnecessary burdens when reviewing devices, permits more efficient device clinical trials; and requires the Food and Drug Administration (FDA) to update guidance on certain point-of-care tests performed in doctors’ offices. Senator Burr introduced this bill with Senator Al Franken (D-MN).

Advancing Targeted Therapies for Rare Diseases ActThis legislation affirms the FDA’s authority to allow innovators to use their own data supporting the approval of a targeted therapy to help facilitate additional targeted therapies to treat patients with the same rare disease. Senator Bur introduced this legislation with Senators Michael Bennet, Elizabeth Warren (D-MA), and Orrin Hatch.

Medical Countermeasure Innovation Act – This legislation encourages the development of medical countermeasures, including drugs, devices and preventative treatments, needed to protect the American people in the event of a global pandemic or biological weapon attack. Despite recent improvements in America’s readiness and response capabilities, the Ebola outbreak and the emergence of public health threats like Zika,  make it clear that more needs to be done to ensure our nation is prepared to protect Americans from these threats. This legislation further supports the development of life-saving products against chemical, biological, radiological and nuclear threats regardless of whether they are naturally-occurring or the result of a deliberate terrorist attack. Senator Burr introduced this legislation with Senator Bob Casey (D-PA).

Sens. Burr and Alexander (R-TN) began the process for advancing Cures legislation this Congress in the United States Senate with the release of joint report in 2015 entitled Innovation for Healthier Americans.

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