Alexander: "21st Century Cures" Law Highlights 2016 Accomplishments of Senate's Health, Education, Labor and Pensions Committee

NASHVILLE, December 20 – Senate Health, Education, Labor and Pensions Committee Chairman Lamar Alexander (R-Tenn.) today highlighted the committee’s accomplishments for 2016 saying that it “was one of the most productive in the Senate, with 24 significant, bipartisan bills now signed into law – including legislation that will help virtually every American family.”

Alexander continued, “For the second consecutive year, President Obama has signed into law what he called last year ‘a Christmas miracle’ made possible by the bipartisan work done on this committee. Last year, it was legislation to fix No Child Left Behind for 50 million children in 100,000 public schools – and this year, it’s the 21^st Century Cures Act, a Christmas medical miracle to make better health possible for nearly every American.

“In addition to the Cures bill, which Senate Majority Leader Mitch McConnell has called ‘the most important legislation of the year,’ this committee has produced new laws to help find faster treatments and cures for the heartbreaking Zika virus as well as legislation to boost doctors’ ability to tackle the opioid epidemic ravaging Tennessee and so many other states. I look forward to next year when our committee can continue its bipartisan work on behalf of American families.”  

Alexander thanked the committee’s ranking Democrat, Sen. Patty Murray of Washington State, and committee members of both political parties for “being willing to focus on the 80 percent of things we can agree on and coming to a result rather than perpetually arguing about the 20 percent on which we can’t agree. Because we took the time to resolve our considerable differences in a bipartisan way, the next Congress and the next President will not be trying to repeal these laws, because in the end almost all of us voted for them.  This is the unique purpose of the United States Senate, to find a consensus on difficult issues for the benefit of the country.” 

The full list of accomplishments is below:

Public Laws:

House Message to accompany 21^st Century Cures (H.R. 34) – Spurs treatments and cures for cancer and Alzheimer’s and drives the research discoveries predicted over the next decade by National Institutes of Health Director Dr. Francis Collins, including the development of an artificial pancreas, organs built from patients' own stem cells, non-addictive painkillers, an HIV/AIDS vaccine and a Zika vaccine, as well as provides $1 billion in state grants to fight opioid abuse and improves mental health programs for the first time in over a decade. The Senate health committee worked on the legislation for two years, held 12 hearings, 5 working groups, and passed 20 bipartisan bills that make up much of the policy signed into law by the president:

HELP Bills Signed into Law as Part of 21^st Century Cures:

1. The Advancing Targeted Therapies for Rare Diseases Act of 2015 – (S. 2030): Advances therapies to patients with serious or life-threatening rare genetic diseases by allowing innovators to rely on their own data used for a previously approved targeted therapies to develop subsequent targeted therapies.
2. Next Generation Researchers Act – (S. 2014): Helps attract talented young scientists to the National Institutes of Health (NIH).
3. The Enhancing the Stature and Visibility of Medical Rehabilitation Research at NIH Act – (S. 800): Requires the National Center for Medical Rehabilitation Research (NCMRR) to develop and periodically update a comprehensive research plan for rehabilitation research.
4. Advancing Research for Neurological Diseases Act of 2015 – (S. 849): Helps advance our understanding of neurological diseases and helps researchers access data on these diseases in order to discover new therapies and cures.
5. Preventing Superbugs and Protecting Patients Act – (S. 2503): Further encourages and clarifies that the Food and Drug Administration (FDA) requires cleaning and validation data for reusable medical devices and to direct the FDA to clarify when device changes require regulatory clearance.
6. The Improving Health Information Technology Act – (S. 2511): Improves health information technology for doctors and their patients.
7. The Advancing Hope Act – (S. 1878): Continues a program that gives drug companies an incentive to develop a drug to treat or cure rare pediatric diseases – if a company develops a drug like that, and it’s approved, they get a voucher they can keep or sell that will speed up the review of another drug.
8. The Advancing Breakthrough Medical Devices for Patients Act of 2015 – (S. 1077): Focuses more of FDA attention and resources and put more senior people at FDA in charge of the review of breakthrough devices so that they will move more efficiently through the review process and get to the patients whose health could be improved by a truly breakthrough device.
9. The Medical Electronic Data Technology Enhancement for Consumers Health Act – (S. 1101): Encourages companies to develop tools like the Weight Watchers application on your iPhone to count calories or a Fitbit watch to log steps, free from unnecessary FDA oversight and red tape.
10. The Medical Countermeasures Innovation Act of 2015 – (S. 2055): Ensures the government is planning ahead by increasing the likelihood there will be a drug to help in the event of bioterror attack with a substance such as anthrax or smallpox. If a company develops such a drug and it’s approved, they get a voucher they can keep or sell that will speed up the review of another drug. 
11. The Combination Products Innovation Act of 2015 – (S. 1767): Helps prevent combination products, such as bandaids with Neosporin built in or heart stents that can be implanted to also deliver blood thinners to prevent clots, from being caught in regulatory red tape between various departments at FDA.
12. Patient Focused Impact Assessment Act of 2015 – (S. 1597): Gives patients and their families a voice in the drug approval process, and requires FDA to hear their opinion.
13. Plan of Safe Care Improvement Act – (S. 2687): Improves plans for safe care for infants affected by illegal substance abuse or withdrawal symptoms.
14. The FDA Device Accountability Act of 2015 – (S. 1622): Reduces unnecessary burdens in device evaluation and streamlines the review process for clinical trials for new medical devices to ensure Americans benefit from these devices more quickly.
15. FDA and NIH Workforce Authorities Modernization Act – (S. 2700): Helps the FDA and NIH attract and retain the talent they need to handle all the exciting developments headed their way for research and review.
16. Promise for Antibiotics and Therapeutics for Health Act – (S. 185): Shortens the development of new treatments to help those infected with life-threatening superbugs.
17. Advancing Precision Medicine Act of 2016 – (S. 2713): Supports the president’s Precision Medicine Initiative to map 1 million genomes and make the information available to researchers who in turn will be required to share their research data – all to help find treatments for diseases sooner.
18. Advancing NIH Strategic Planning and Representation in Medical Research Act – (S. 2745): Requires NIH to come up with a strategic plan at least every six years, and helps ensure that scientists are including women and minorities in their research and reports on the differences they find.  
19. Promoting Biomedical Research and Public Health for Patients Act – (S. 2742): Allows researchers at the NIH to spend more time finding life-saving treatments and cures and less time on paperwork.
20. Mental Health Reform Act of 2016 – (S. 2680): Ensures that mental health programs are effectively serving those with mental illnesses and improves access to mental health care.

Bills Signed into Law as Part of the Comprehensive Addiction and Recovery Act (CARA) – Supports education, prevention, treatment, and recovery efforts to address the opioid abuse crisis and help individuals with an opioid use disorder get and stay well.

The final bill signed by the president included two Senate health committee bills:

1. The Recovery Enhancement for Addiction Treatment Act – (S. 1455): Increases the number of patients that a qualifying physician can dispense narcotic drugs for maintenance or detoxification treatment from 30 to 100 patients a year.
2. Co-Prescribing Saves Lives Act of 2015 – (S. 2256): Requires the Department of Health and Human Services to provide information on best practices for prescribing a drug used to rapidly reverse an overdose of opioids for patients receiving chronic opioid therapy or being treated for opioid use disorders.

Adding Zika Virus to the FDA Priority Review Voucher Program Act (S. 2512) – Gives drug companies an incentive to develop a drug or vaccine for the Zika virus, to spur a faster treatment, cure or vaccine.

Expanding Capacity for Health Outcomes – ECHO Act (S. 2873) – Connects the medical brain power of institutions like Vanderbilt University Medical Center to doctors in rural areas of the country to better treat patients with complex diseases.

Passed by the Senate:

Joint resolution providing for congressional disapproval of the “fiduciary” rule (H.J. Res. 88) – Would have invalidated the Department of Labor’s so-called “fiduciary” rule, which will likely cripple low- and middle-income Americans’ access to affordable retirement advice—forcing Americans to work longer and retire with less.

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