21st Century Cures Law Will Improve Health of Tennesseans

Senator Lamar Alexander
2016-12-21 16:25:07
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December 20, 2016-

On December 13, President Obama signed the 21st Century Cures Act into law – delivering a “Christmas Medical Miracle” to Tennessee families. Video of the signing ceremony is available 21st Century Cures Law Will Improve Health of Tennesseans 

This month, Congress and President Obama delivered a Christmas miracle called “21st Century Cures” that will help improve the health of virtually every Tennessean.

This $6.3 billion bipartisan law will help us find cures for cancer, fight opioid addiction, treat mental illness, and better understand the brain to prevent diseases like Alzheimer’s.

It will help take advantage of this remarkable time in biomedical innovation, spur treatments and cures from cancer to rare pediatric diseases, and help move those treatments and cures more efficiently into medicine cabinets and doctors’ offices, while maintaining our gold standard of safety.

The president said this bipartisan legislation was “an opportunity to save lives, and an opportunity we just can’t miss.”

U.S. Senate Majority Leader Mitch McConnell called it “the most important legislation Congress will pass this year.”

I’ve worked on this bill for two years as chair of the Senate health committee.  Working with the senior Democrat Patty Murray (D-Wash.), we held 12 hearings, led 5 working groups, and passed 19 pieces of bipartisan legislation that formed much of the policies in this bill.

Working with our counterparts on the House health committee--Chairman Fred Upton (R-Mich.), and Democrats Frank Pallone (D-N.J.) and Diana DeGette (D-Colo.)--we also put together a surge of funding to help make dramatic strides in cancer treatments, to help advance our understanding of the brain and Alzheimer’s, and to help achieve the promise of precision medicine, or specific, individualized treatments tailored to each person’s unique genome and environment.

Dr. Francis Collins, the head of the National Institutes of Health, has made “bold predictions” about the breathtaking advances to expect during the next decade from medical research: an artificial pancreas to treat diabetes, vaccines for HIV/AIDS and Zika, a universal flu vaccine, non-addictive pain medicines, a heart built from a patient’s own cells, and early detection or even prevention of Alzheimer’s.

Especially important for Tennessee, the bill will provide $1 billion in grants to states to help fight the opioid crisis.

The new law also will help the one in five adults in this country who suffer from a mental illness get the treatment they need by the making the largest reforms to major mental health programs in a decade.

It also takes a significant step to help more Americans take advantage of regenerative medicine, which the Mayo Clinic has described as a “game-changing area of medicine with the potential to fully heal damaged tissues and organs.”

Nashville resident Doug Oliver has been an advocate for regenerative medicine. Doug was blind for more than a decade before doctors used stem cells from his hip and injected them into his eye and miraculously restored his sight. He has traveled to Washington multiple times to share his story and even helped my staff craft pieces of this legislation.

Former Senate Majority Leader Bill Frist of Tennessee has worked for two years with the Bipartisan Policy Center to help advance the legislation.

21st Century Cures will modernize the Food and Drug Administration. While biomedical research is making today one of the most exciting times ever in the field of medicine, our federal review and approval process takes too long and costs too much.

The bill improves electronic health records to reduce the documentation burden for doctors and make it easier for patients to access their records and for doctors and hospitals to get the information they need to treat patients.

All these pieces will work together to help improve the lives and health of virtually every Tennessee family. That’s why this new bipartisan law is a Christmas miracle.

Below is a Wall Street Journal editorial on 21st Century Cures and some of the things others are saying about the bill:

Wall Street Journal Editorial: Congress’s Cures Breakthrough

Modest progress toward bringing the FDA into the 21st century

December, 7, 2016 - Medicine moves faster than government, thank goodness, but every now and again government tries to catch up. After years of thoughtful bipartisan work, Congress is now poised to pass the 21st Century Cures Act, a bill designed to accelerate the development of new medicines and modernize a malfunctioning corner of the regulatory state.

The sweeping measure cleared a Senate procedural vote 85-13 on Monday night and passed the House 392-96. These margins are testimony to renewed self-confidence in U.S. innovation and health-care progress, not much expressed in Washington until recently. A few dead-enders like Bernie Sanders and Elizabeth Warren are denouncing Cures for its lack of pharmaceutical price controls, which might have become a reality had Hillary Clinton won on Nov. 8.

Cures includes a $4.8 billion infusion for the National Institutes of Health for basic research. The bill funds the NIH’s neurological program on diseases like Alzheimer’s, Joe Biden’s “cancer moonshot” and rare diseases, while one encouraging earmark is for “high risk, high reward” studies that might not be financed by the private economy.

By the way, these new dollars are roughly offset with budget cuts elsewhere, which exposes the liberal claims of crisis if every program doesn’t last forever. Congress is supposed to set priorities.

Perhaps the most promising component of Cures is a new regulatory model for Food and Drug Administration approvals. The FDA remains fused to an outdated clinical model that is too slow, costly and arbitrary. The FDA was not designed to govern an era of genomics, biomarkers, systems biology, artificial intelligence and other advances, not that its own inadequacy has prevented it from trying.

Thus Cures encourages the FDA to supplement classical randomized clinical trials with more information, such as adaptive trial designs that target patient sub-groups who are more likely to benefit. This would allow research to succeed or fail faster at some fraction of the current expense. The agency is also ordered to consider “real-world evidence” in approvals outside of trials.

What the FDA calls “RWE” is controversial because the agency is preoccupied with “proving” how a medicine will perform. But modern trials are so tightly controlled that the results are often artificial, or irrelevant to how a medicine will be used and refined in actual medical practice. In any case, debates about drug approval are never about “proof,” but how to interpret evidence of benefits and risks.

The main limitation of Cures is that the problems at FDA aren’t due to a shortage of laws. They flow from the agency’s institutional culture of control, delay and abuse of regulatory discretion. Cures requires the FDA merely “to evaluate the use of real-world evidence,” and this wouldn’t be the first political instruction that the bureaucracy has defied.

Still, Cures is a stride toward a more rational and humane drug development system, and legislation is about compromise. The bill could become a useful precedent for successful progress as the 115th Congress starts to take shape next year.

 

Sen. Alexander talks at the Congressional Enrollment Ceremony for the 21st Century Cures Act on Dec. 8. Following the Senate’s overwhelming st Century Cures Act, the bill was sent to Speaker Paul Ryan (R-WI) before moving to the White House for the president’s signature. 

Talking about Cures

“[Cures] is the most important legislation Congress will pass this year.”

    -- Senate Majority Leader Mitch McConnell

“It could help us find a cure for Alzheimer’s, end cancer as we know it, and help those seeking treatment for opioid addiction…It’s an opportunity to save lives and an opportunity we just can’t miss.” 

    -- President Barack Obama, 12/3/2016

“A big step for cancer research and the cancer moonshot.”

    -- Vice President Joe Biden

"Passage of this legislation is a testament to Sen. Alexander's leadership and will help countless Tennesseans who are directly impacted by cancer, Alzheimer's, mental illness and opioid abuse. By streamlining the FDA review process and advancing biomedical research, this bill will encourage innovation and provide quicker access to the lifesaving medications and treatments that so many families need."

    -- Sen. Bob Corker (R-Tenn.), 12/7/2016

“Alexander shepherded"the 21st Century Cures Act through the Senate for approval. The two senators play powerful roles in their chamber and have brought to Washington, D.C., Tennessee politicians’ gifts for thoughtfulness, compromise and collaboration, at a time when gridlock has often prevailed.”

    -- David Plazas, opinion engagement editor for The Tennessean, 12/11/2016

“In a day when approval of Congress barely exceeds 10 percent of poll respondents and few believe the body ever gets anything meaningful done, the 21st"Century Cures Act is, if you will, a remedy"of sorts. …Though Alexander called the legislation "a Christmas miracle," Congress will never have enough money to fund everything researchers need and everything those seeking a cure want. Because when you have your health, you have everything. But this bipartisan bill offers hope to those seeking to regain or retain their health.”

    -- Clint Cooper, Free Press editor at the Chattanooga Times Free Press, 12/9/2016 

“The so-called “do nothing” Congress has done something before taking its end-of-the-year holiday break. …Tennessee’s own Lamar Alexander was the lead sponsor of the bill in the Senate. The legislation received strong bipartisan support, including from the White House where President Barack Obama has promised to sign the measure into law.”

    -- Johnson City Press editorial, 12/11/2016

“From a political standpoint, the [Cures] proposals are remarkable"because they have managed to draw broad support from Democrats and Republicans in a contentious presidential election year.”

    -- Michael Collins of the Knoxville News Sentinel, 4/10/2016

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