21st Century Cures Act heads to Barack Obama’s desk
Congress has approved the first major mental health legislation in nearly a decade Wednesday. The 21st Century Cures Act, which overhauls the development of medical treatments and cures, is likely to be one of the final pieces of legislation President Barack Obama will sign into law before he leaves office next month. The Senate voted 94-5 on Wednesday to approve the bill, following the House’s passage (344-77) just last week. The 21st Century Cures Act improves: Discovery: by providing the NIH with fully offset funding to advance the Precision Medicine Initiative to drive research into the genetic, lifestyle, and environmental variations of disease; speed up cancer research; and invest in the BRAIN initiative to improve our understanding of diseases like Alzheimer’s. Development: by turning 21st Century scientific advancement and research into FDA-approved treatments and cures through modernizing clinical trials; putting patients at the center of the regulatory review process; streamlining regulations to foster innovation in health care software and mobile medical apps; incentivizing pediatric drug development and empowering the FDA to be more flexible in reviewing medical devices and technologies; and providing the FDA with $500 million for regulatory modernization and enable the agency to recruit the best scientists, doctors, and engineers. Delivery: by ensuring new drugs and devices are given to the right patients at the right time through ensuring that electronic health record systems seamlessly operate for best patient care; facilitating seniors’ access to the latest medical technology; and improving education for health care providers. Mental Health Care: by coordinating mental health programs across the federal government; establishing the National Mental Health and Substance Use Policy Lab to drive evidence-based grants to help states combat addiction and abuse; clarifying HIPAA communication rules among providers, families, and patients to improve treatment; and strengthening our nation’s mental health workforce. Here’s how the Alabama delegation voted and what they had to say about the bill: Sen. Richard Shelby: America has long been the world’s leader in medical innovation and it is important that we modernize, personalize, and streamline our health care delivery system to ensure that it meets the demands of today. For the millions of Americans suffering from a serious illness such as cancer or Alzheimer’s, cutting-edge research is the beginning of hope for them and their loved ones. I have always been a strong proponent of ensuring that we appropriately support first-rate medical innovation and research initiatives for the next generation of treatments and cures. The 21st Century Cures Act will not only foster needed changes in our health care infrastructure, but it also takes critical steps to fight our nation’s growing opioid epidemic and strengthen our mental health programs. It is great news for the American people that both the House and Senate have passed this bipartisan legislation. Alabama 1st District U.S. Rep. Bradley Byrne: I think the 21st Century Cures Act may end up being the most important bill passed by Congress over the last few years. In addition to helping boost medical research, the bill also dedicates resources to mental health reform and fighting our nation’s opioid crisis. I outline why I supported this bold legislation in my column this week. Alabama 2nd District U.S. Rep. Martha Roby: The 21st Century Cures Act fosters innovation in medical technology and research, eliminates regulations that hinder competition, provides resources to combat the growing opioid epidemic, ensures critical support for those struggling with mental health issues, and rightfully reforms Medicare and Medicaid to reduce overpayments and provide reimbursements. The bill improves medical treatment discovery, development, and delivery for those who need it most. Alabama 3rd District U.S. Rep. Mike Rogers: No comment given at this time. Alabama 4th District U.S. Rep. Robert Aderholt: No comment given at this time. Alabama 5th District U.S. Rep. Mo Brooks: No comment given at this time. Alabama 6th District U.S. Rep. Gary Palmer: No comment given at this time. Alabama 7th District U.S. Rep. Terri Sewell: From the biomedical research community in Birmingham to my constituents who live with rare diseases and hospitals who serve a disproportionate share of low-income patients, all Alabamians will benefit from implementation of the 21st Century Cures Act. I am particularly pleased that the bill includes critical support for rural health care, regulatory relief for Long-Term Acute Care and Critical Access Hospitals, and increased funding for cutting-edge biomedical research. In addition, the bill provides substantial relief from readmission penalties to Alabama’s hospitals, the majority of which serve a disproportionate share of low-income patients.
Bradley Byrne: A bill that can save lives
I met a young boy named Gabe Griffin a few years back at Battleship Park in Mobile. His family and friends had organized a cross country bike ride that started in Oregon and ended on Alabama’s Gulf Coast. The goal of the ride was to raise awareness about Duchenne muscular dystrophy, a rare disease in young boys that causes your muscles to weaken rapidly. Despite suffering from Duchenne, Gabe was thrilled that day to be greeted by the University of South Alabama mascots, the Azalea Trail Maids, and local firefighters. I will never forget the smile on Gabe’s face on that special day. Gabe was on my mind last week as I cast my vote in favor of the 21st Century Cures Act. This bill brings health research and the drug approval process into the 21st Century in order to boost research into diseases, like Duchenne, that impact far too many families. The bill provides the National Institutes of Health with over $4 billion in new funding. Over $1 billion will go toward the new Precision Medicine Initiative to drive research into diseases, over $1 billion will go toward cancer research, and over $1 billion will go toward the BRAIN initiative to improve understanding of diseases, like Alzheimer’s. The 21st Century Cures Act also allows for the Food and Drug Administration (FDA) to expedite the approval process for breakthrough medical treatments, drugs, and devices. These reforms help cut through the red tape and bureaucracy that has limited the potential for important medical breakthroughs. The bill encourages innovation and research through a number of new strategies. For example, 21st Century Cures authorizes innovation prize competitions to advance biomedical science for diseases that are serious and represent a significant burden. The bill also creates a new “Next Generation of Researchers Initiative” to encourage younger students to enter the field of medical research. Another important reform is that 21st Century Cures empowers patients to take part in research and clinical trials. This change allows patients to voluntarily provide hospitals and research institutions with authorization to use their personal health data for research purposes. The bill also requires the FDA to incorporate patient input and experiences into their decision-making process. All of these reforms ensure that the United States remains a global leader in medical innovation, which in turn protects and helps create new jobs here at home. The bill also includes important reforms to update our nation’s mental health programs. Mental health reform has long been a priority for me, and I know these reforms will go a long way toward changing the way we treat mental illness in America. Another important issue addressed in the bill is the opioid prescription drug crisis impacting communities all across the country. Approximately 46,000 Americans die each year because of prescription drug abuse, so I’m pleased to report the bill includes $1 billion in new grants that can be given to states to help them combat opioid abuse. Importantly, all new spending in the bill is offset, and the Congressional Budget Office estimates the bill will actually result in government savings. The 21st Century Cures Act has been years in the making. Gabe, and many others who suffer from major diseases, have been traveling to Washington for over two years to advocate for this critical legislation. Legislation that gives them hope. It is not often that Congress passes legislation that can actually save lives, but that is exactly what the 21st Century Cures Act has the potential to do. Just as important though, it also gives hope to people like Gabe and his family that a cure can be found. And sometimes, hope is exactly what you need. • • • Bradley Byrne is a member of U.S. Congress representing Alabama’s 1st Congressional District.
U.S. House of Representatives: July 6-10
The U.S. House of Representatives returns Tuesday after a weeklong holiday recess ready to tackle a busy July agenda. They’ll begin with a vote on three noncontroversial bills under suspension of the rules. After Tuesday’s suspension votes, members will resume consideration of H.R. 2822: the Interior, Environment, and Related Agencies Appropriations Act for FY 2016. The bill provides a total of $30.2 billion in discretionary spending in FY 2016 for the Interior Department, the EPA, the Forest Service and a variety of other agencies. That total is $246 million (1 percent) less than current funding and $3.1 billion (9 percent) less than requested by the Obama administration. It’s considered a controversial bill because it decreases funding for EPA by 9 percent and limits the EPA’s regulatory authority. It also cuts funding for Forest Service activities and for the Fish and Wildlife Service. Other legislation on the floor for a vote this week includes: H.R. 5: the Student Success Act. The House originally began consideration of H.R. 5 in February, but postponed completing consideration at that time. The bill reauthorizes the Elementary and Secondary Education Act (ESEA, sometimes also referred to No Child Left Behind, NCLB). The bill makes fundamental changes to many ESEA programs. Alabama co-sponsors: Rep. Bradley Byrne (AL-1) H.R. 6: the 21st Century Cures Act. This bill is a bipartisan medical research and innovation bill intended to assure American leadership in biomedical research for the future and to allow drugs to get to patients more quickly, while also ensuring they are safe and effective for use. Alabama co-sponsors: Rep. Mike Rogers (AL-3) H.R. 2647: the Resilient Federal Forests Act of 2015. The bill would modify federal forest management practices by restoring fundamental land management capabilities to the U.S. Forest Service, such as routine thinning practices to improve forest health and reduce wildfire threats. Alabama co-sponsors: Rep. Gary Palmer (AL-6) Aside from the floor activity, the House will continue to work with the Senate through a conference committee to resolve the differences between their two versions of the National Defense Authorization Act. They are hoping to produce a final conference report before the August congressional recess, despite that President Barack Obama has threatened to veto the defense policy bills produced by both of the chambers.
