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21st Century Cures Act Big Win for Patients

Wednesday, November 30, 2016

Washington, D.C. – The Bipartisan Policy Center calls today’s passage of the 21st Century Cures Act by the House of Representatives a significant opportunity to bring the promise of cures to those with Alzheimer’s, cancer, Parkinson’s, and other life-threatening diseases. The bill includes a majority of BPC’s recommendations that were released in its July 2015 report, Advancing Medical Innovation for a Healthier America.

“As a medical doctor, I have witnessed the potential of life-changing treatments,” said former Senate Majority Leader Bill Frist. “This bill will significantly advance much needed medical innovation and accelerate cures in the United States. As this legislation moves to the Senate, we urge continued bipartisan collaboration to get this bill over the finish line before the end of the year.”

BPC praises the House and Senate health committee leaders and its members for their unwavering efforts to create this new bill and pass medical innovation legislation this year including: House Energy and Commerce Committee Chairman Rep. Fred Upton (R-MI) and Ranking Member Rep. Frank Pallone, Jr. (D-NJ); House Oversight and Investigations Subcommittee Ranking Member Rep. Diana DeGette (D-CO); House Health Subcommittee Chairman Rep. Joe Pitts (R-PA) and Health Subcommittee Ranking Member Rep. Gene Green (D-TX); and Senate Health, Education, Labor, and Pensions Committee Chairman Sen. Lamar Alexander (R-TN) and Ranking Member Sen. Patty Murray (D-WA).

The 21st Century Cures Act will offer hope to patients and bolster progress in research, new medicines, and treatments.

“This is a pivotal opportunity in our country to take bipartisan action that will support millions of Americans,” said former Rep. Bart Gordon. “This legislation will offer hope to patients and bolster progress in research, new medicines, and treatments. We strongly encourage Congress and the president to complete this important work by enacting the legislation this year.”

In 2014, BPC launched its medical innovation initiative under the leadership of Frist and Gordon, and released a comprehensive set of recommendations in July 2015. This new Cures legislation includes provisions from the following BPC priorities:

  • Involving patients as partners in the development of drugs and devices to ensure their experiences are reflected in assessments of treatment benefits and risks
  • Improving and expanding the qualification and use of drug development tools, such as biomarkers and patient-reported outcomes to support a more effective and efficient drug development process
  • Strengthening the Food and Drug Administration (FDA) to carry out its mission by enhancing its ability to hire and retain scientific expertise
  • Advancing the President’s Precision Medicine Initiative to support individualized treatments tailored to a patient’s genetic make-up, environment, and lifestyle
  • Improving the regulation of regenerative cell therapies, by enabling the FDA to grant accelerated approval of such therapies deemed to be safe and effective
  • Utilizing real-world evidence—data that reflects the actual experience of patients—to support approval of a new indication for an existing drug and satisfy post-approval study requirements
  • Improving the regulation of combination products, which are hybrid products which contain a combination of a drug, device, and/or biologic.
  • Clarifying regulatory authority for medical software and increasing interoperability and electronic health information sharing to improve health and health care
  • Improving processes for early patient access to medical products by requiring sponsors to have publicly accessible compassionate use policies for drugs treating serious or life-threatening conditions
  • Providing FDA with the flexibility to approve antimicrobial drugs for a limited population.

The bill also increases funding at the National Institutes of Health for President Obama’s Precision Medicine Initiative, cancer prevention and research, as included in Vice President Biden’s “Cancer Moonshot”, Alzheimer’s research through the BRAIN Initiative, and regenerative medicine. It also makes major mental health system reforms and offers grants to states to combat America’s opioid crisis. All new funding is contingent upon appropriations by Congress, offset by other provisions in the bill.

“It can take more than ten years and $2 billion for new drugs and other therapies to get to market,” said Janet Marchibroda, BPC’s director of health innovation. “This new legislation will help accelerate the discovery, development, and delivery of life-saving, safe, and effective cures for patients.”

View BPC’s work on medical innovation.

KEYWORDS: 21ST CENTURY CURES, BART GORDON, BILL FRIST, DIANNA DEGETTE, FRANK PALLONE, FRED UPTON, GENE GREEN, HOUSE ENERGY AND COMMERCE COMMITTEE, JANET MARCHIBRODA, JOE PITTS, LAMAR ALEXANDER, PATTY MURRAY, SENATE HELP COMMITTEE