It is exceedingly rare for important legislation to gain broad bipartisan support. The 21st Century Cures Act , introduced by Rep. Fred Upton (R-Michigan) in 2015, is an exception. The measure, introduced by a Republican, was signed into law by President Obama yesterday.

It provides for a NIH and Cures Innovation Fund for for biomedical research, including high-risk, high-reward research and research conducted by early stage investigators, and allows the development and implementation of a strategic plan for biomedical research.

The House of Representatives’ Energy and Commerce Committee summarizes the new law:

“THE 21ST CENTURY CURES ACT [is] An innovation game-changer, a once-in-a-generation, transformational opportunity to change the way we treat disease. The House Energy and Commerce Committee and the Senate HELP Committee have engaged in a public, nonpartisan conversation with patients, researchers, innovators, and health care providers about what steps can be taken to expedite the discovery, development, and delivery of new treatments and cures and maintain America’s global status as the leader in biomedical innovation. The 21st Century Cures Act (“Cures”) is the product of that conversation.

“The National Institutes of Health will get $4.8 billion in new funding that is fully offset. These dollars will help advance the Precision Medicine Initiative to drive research into the genetic, lifestyle and environmental variations of disease ($1.5 billion); bolster Vice President Biden’s “Cancer Moonshot” to speed research ($1.8 billion); and invest in the BRAIN initiative to improve our understanding of diseases like Alzheimer’s.

“The pace of scientific advancement over the past two decades, including the mapping of the human genome, has been impressive. Translating these discoveries into new FDA-approved treatments, however, has proven difficult. Cures will advance new therapies for patients by:

Modernizing clinical trials and the means by which safety and efficacy data is accumulated and analyzed.
Putting patients at the heart of the regulatory review process. • Supporting broader, more collaborative development, qualification, and utilization of biomarkers, which help assess how a therapy is working, and on whom, earlier in the process.
Streamlining regulations and provides more clarity and consistency for innovators developing health software and mobile medical apps, combination products, vaccines, and regenerative medicine therapies.
Incentivizing the development of drugs for pediatric diseases and medical countermeasures, and empower FDA to utilize flexible approaches in reviewing medical devices that represent breakthrough technologies.
Providing FDA with $500 million for regulatory modernization and give the agency the ability to recruit and retain the best and brightest scientists, doctors, and engineers.

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“The development of new drugs and devices is meaningless unless they are delivered to the right patients at the right time. Cures will help improve delivery by:

ensuring electronic health record systems are interoperable for seamless patient care and help fully realize the benefits of a learning health care system.
Improving education for health care providers and help facilitate seniors’ access to the latest medical technology.

“Our work to advance meaningful mental health reforms has been a multi-year, multi-Congress effort. The mental health reforms included in the revised 21st Century Cures Act are based largely on H.R. 2646, the Helping Families in Mental Health Crisis Act, authored by Rep. Tim Murphy (R-PA), which passed the House in July by a vote of 422-2. This legislative effort represents the most significant reforms to the mental health system in more than a decade. These landmark reforms will:

Create a new Assistant Secretary for Mental Health and Substance Use to replace the Administrator at SAMHSA and coordinate mental health programs across the federal government.
Establish the National Mental Health and Substance Use Policy Lab to drive evidencebased grant making within SAMHSA.
Direct the Secretary of HHS to undertake guidance to clarify when communication can take place under HIPAA to help ensure communication among providers, families, and patients to improve mental health treatment.
Improve mental health care for children with serious emotional disturbance, or adults with serious mental illness, through targeted authorizations and reauthorizations, including expansion of Assisted Outpatient Treatment.
Strengthen the nation’s mental health workforce.”

Vice President Biden, who lost his son Beau to cancer, was particularly gratified at the enactment of the CURES legislation. He noted:

“[It’s] personal for me and for millions of Americans: The 21st Century Cures Act invests $1.8 billion to help us end cancer as we know it. For over a year, I’ve been leading our National Cancer Moonshot to fundamentally change the culture of our fight against cancer and inject a sense of urgency into it. This bill goes a long way to help us — investing in promising new therapies, enhancing prevention and detection efforts in every community regardless of zip code, and bringing us closer to the day when there are vaccines for all kinds of cancer, just as we have them for measles or mumps.

“While I was presiding in the Senate, my colleagues from both sides of the aisle renamed the section of this bill on cancer research for my son, Beau, who lost his battle with brain cancer, but like countless Americans who lost their own battles, inspires us to do everything we can for the loved ones we can save. My thanks goes out to the bipartisan leadership — Democrats and Republicans in the House and the Senate — who ensured that this important bill became law. Without this true bipartisan support, this piece of legislation, which will help millions of Americans, would not have been possible.”