Press Releases
Washington, D.C.—Senate President Pro Tempore Orrin Hatch, R-Utah, and House Speaker Paul Ryan, R-Wis., signed critical legislation this afternoon to help find cures for diseases like cancer and Alzheimer’s and to fight the ongoing opioid epidemic. The bill, the 21st Century Cures Act, recently passed the House and Senate, and included several key provisions with a direct impact on Utah championed by Senator Hatch.
The bipartisan package, which Senate Majority Leader Mitch McConnell, R-Ky., called “the most important legislation Congress will pass this year,” represents a successful effort to bring together every part of the scientific and medical communities to address the most pressing issues facing patients across the country.
By investing in the National Institutes of Health, the legislation makes major strides toward goals like eliminating cancer, expanding our understanding of the brain to better treat diseases, and tapping into genetic information to individualize a patient’s course of care. Moreover, this bill represents a major step in improving our response to mental health issues, addiction, and substance abuse. This proposal will directly benefit Utahns by empowering and funding state innovations to address our most elusive health challenges.
The legislation includes six of Senator Hatch’s bills:
S. 185, the Promise for Antibiotics and Therapeutics for Health (PATH) Act: The PATH Act would address the difficulty in recruiting participants for research and development of some of the most urgently needed new antibiotics—those for serious or life-threatening infections with unmet needs (few or no treatment options). Utilizing pathways similar to orphan drugs, this bill allows antibiotics to be studied so that our nation can better address the growing threat of superbugs and anti-microbial resistance.
S. 1101, the Medical Electronic Data Technology Enhancement for Consumers Health (MEDTECH) Act: The MEDTECH Act clarifies the regulation of health information technology by identifying five specific categories of medical software that, given certain conditions, should not be regulated as a medical device by the Food and Drug Administration based on their low level of risk to patients. This advancement ensures that regulations of low-risk technologies do not stymie innovation.
S. 2030, Advancing Targeted Therapies for Rare Diseases Act: This bill will incentivize drug development, help overcome the difficulties of doing conventional trials for many rare diseases, conserve FDA’s limited resources, bring needed therapies to patients faster, and make treatments available where there otherwise would be no other options.
S. 2511, Improving Health Information Technology Act: This bill reforms the current certification for electronic health records (EHRS), as well as reforming standards and encouraging trusted exchange while reducing provider burden and duplicative processes.
S. 1077, Advancing Breakthrough Medical Devices for Patients Act: This bill will expedite the development and provide for priority review of medical devices that represent breakthrough technologies, have no approved alternatives, offer significant advantages over existing alternatives, or would increase patient access to treatment.
S. 800, Enhancing the Stature and Visibility of Medical Rehabilitation Research at NIH Act: This bill will establish a working group within the NIH to update and streamline rehabilitation research priorities, promote interagency cooperation on rehabilitation research between NIH and other agencies, and explore the feasibility of implementing the Blue Ribbon Panel Recommendations on Rehabilitation Research released in December 2012.
The 21st Century Cures package also contains other legislation that Senator Hatch originated or sponsored during his tenure. The Garrett Lee Smith Memorial Act, which aims to prevent youth suicide, is reauthorized in Cures, continuing a decade of work on the issue by the Senator. The STOP Act, which aims to reduce underage drinking, is also reauthorized in this bill and was originally cosponsored by Senator Hatch. Additionally, the Community Mental Health Services Block Grants and Substance Abuse Prevention and Treatment Block Grants that are reauthorized in the Cures package were created under Senator Hatch’s chairmanship of the Labor & Human Resources Committee (now the Health, Education, Labor, and Pensions Committee). Of additional note in the mental health community is the notion of mental health parity, which Senator Hatch championed at its original passage and is contained in the mental health provisions of the Cures bill. The Cures Act also reauthorizes the National Pediatric Research Network Act, another one of Senator Hatch’s key priorities that brings together pediatric hospitals and researchers to pool expertise and resources as they work to treat pediatric rare diseases and birth defects.
