The 21st Century Cures Act is a United States law enacted by the 114th United States Congress in December 2016. It authorized $6.3 billion in funding, mostly for the National Institutes of Health. The act was supported especially by large pharmaceutical manufacturers and was opposed especially by consumer organizations.
Proponents said that it would streamline the drug and device approval process and bring treatments to market faster. Opponents said that it would allow drugs and devices to be approved on weaker evidence, bypassing randomized, controlled trials, and bring more dangerous or ineffective treatments to market.
The bill included the Helping Families In Mental Health Crisis Act, which increased the availability of psychiatric hospital beds and established a new assistant secretary for mental health and substance use disorders.
Video 21st Century Cures Act
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Research and drug development
Division A, which shares the title "21st Century Cures Act," contains provisions related to National Institutes of Health funding and administration, reducing opioid abuse, medical research, and drug development.
Opioid epidemic
The Comprehensive Addiction and Recovery Act (CARA) was passed a few months earlier. This act authorized many harm-reduction strategies, including increased access to the overdose reversal drug naloxone, for the opioid crisis, but didn't provide any federal funding for implementation. The 21st Century Cures Act designated $1 billion in grants for states over two years to fight the opioid epidemic. The money may be used to improve prescription drug monitoring programs, to make treatment programs more accessible, to train healthcare professionals in best practices of addiction treatment, and to research the most effective approaches to prevent dependency.
FDA drug approval process
The 21st Century Cures Act modified the FDA Drug Approval process. It was intended to expedite the process by which new drugs and devices are approved by easing the requirements put on drug companies looking for FDA approval on new products or new indications on existing drugs. For instance, under certain conditions, the act allows companies to provide "data summaries" and "real world evidence" such as observational studies, insurance claims data, patient input, and anecdotal data rather than full clinical trial results.
Informed consent
The 21st Century Cures Act allows researchers to waive the requirement for "informed consent" in specific cases where the devices being tested don't pose any health risks beyond those of normal everyday life and wouldn't direct a patient's care in any way. An example that has been given is a high-tech bandage that monitors blood flow from a serious wound, which functions just like a regular bandage but only has this added benefit of possibly monitoring blood flow. Ordinarily, researchers would obtain the patient's permission before testing any new device on them. However, in this example, researchers might want to test the bandage in a real-world scenario where patients may not be conscious. In such circumstances, researchers may waive an informed consent requirement, since it would be difficult or impossible to obtain, and the patient is still getting the standard, medically accepted care of blood pressure and heart rate monitoring. Researchers will still need to obey standard research protocols including institutional review boards to approve their research design and ethics.
Medical research
The act allocates $4.8 billion to the National Institutes of Health for precision medicine and biomedical research. Of this, $1.5 billion is earmarked for research on brain disease. Another $1.8 billion is dedicated to cancer research in what is called the "Beau Biden Cancer Moonshot" initiative, named in honor of Vice President Joe Biden's son, who died of brain cancer in 2015.
Strategic Petroleum Reserve sales
The act requires sale of 25 million barrels of crude oil (10,000,000 in 2017, 9,000,000 in 2018, and 6,000,000 in 2019) from the Strategic Petroleum Reserve. Revenue from these sales will provide part of the NIH funding provided in the law.
Behavioral health
Division B of the law, the "Helping Families in Mental Health Crisis Reform Act of 2016," addresses the prevention and treatment of mental illnesses and substance abuse, treatment coverage, communication permitted by HIPAA, and interactions with law enforcement and the criminal justice system.
The law strengthens mental health parity regulation, which require insurance companies to cover mental health treatments to the same extent and in the same way as medical treatments. It also includes grants to provide community mental health resources, suicide prevention and intervention programs, and de-escalation training for law enforcement. It also provides five-year grants for a demonstration program in which psychiatry residents and other mental health clinicians will practice in underserved areas. Provisions for reform of HIPAA, elevating the standing of families in commitment decisions, and reforms of procedures for challenging release decisions, which had been developed by renowned forensic psychiatrist Dr. Michael Welner, were not included in the final bill.
Some of these provisions were originally proposed in earlier bills, including the Mental Health Reform Act of 2016 (S. 2680); the Mental Health and Safe Communities Act of 2015 (H.R. 3722, S. 2002); the Helping Families in Mental Health Crisis Act of 2016 (H.R. 2646); the Comprehensive Justice and Mental Health Act of 2015 (H.R. 1854, S. 993); the Mental Health Awareness and Improvement Act of 2015 (H.R. 5327, S. 1893); the Justice and Mental Health Collaboration Act of 2015 (H.R. 731); and the Behavioral Health Care Integration Act of 2016 (H.R. 4388).
Healthcare access and quality improvement
Division C of the law, the "Increasing Choice, Access, and Quality in Health Care for Americans Act," concerns Medicare programs and federal tax laws related to health plans for small employers.
Maps 21st Century Cures Act
Legislative history
Another bill with the same name, H.R. 6, was introduced by Fred Upton (R-MI) on May 19, 2015. It passed the House on July 10, 2015. but in the Senate, it died in committee.
More than 1,400 registered lobbyists worked on this bill, representing more than 400 different organizations, mostly pharmaceutical companies. The bill passed the House first by a wide margin. Only five senators voted against it: Elizabeth Warren of Massachusetts, Bernie Sanders of Vermont, Ron Wyden and Jeff Merkley, both of Oregon, all Democrats, and Mike Lee, a Republican of Utah. Warren, Sanders and Merkley, in particular, objected to the pharmaceutical industry's influence on the bill. In early December 2016, the act had support from both houses of congress.
President Obama signed the act on December 13, 2016. The reasons stated for his support included counting opioid abuse, advancing cancer research, advancing the BRAIN Initiative, advancing the Precision Medicine Initiative, and addressing bipartisan health issues.
Reception
Stakeholders who praised the passing of the act include drug companies; medical device manufacturers; the National Institutes of Health; people advocating for lowered barriers to collecting human subject research data; Representatives Fred Upton (R-MI), Diana DeGette (D-CO), Timothy F. Murphy (R-PA); Senator Lamar Alexander (R-TN); and Vice President Joe Biden. Hospitals and universities, as well as the American Cancer Society Action Network, Research!America, and FasterCures supported the bill for its commitment toward funding research. The American Psychological Association supported the bill due to its mental health provisions. The Advanced Medical Technology Association supported the bill for easing the process of introducing new medical technologies. The American Society of Human Genetics (ASHG) commended the passage of the bill for strengthened genetic privacy for research participants. Prison Fellowship supported the bill due to its inclusion of the Comprehensive Justice and Mental Health Act, a portion designed to encourage collaboration among criminal justice, juvenile justice, mental health treatment, and substance abuse systems.
Stakeholders who criticized the passing of the act include the FDA, advocates for strong protections in clinical research, consumer organizations, and advocates of regenerative medicine. The expedited drug approval process has been one topic of concern and debate The Public Citizen's Health Research Group and the National Center for Health Research campaigned against the Cures Act in fear that it will endanger public health by weakening FDA standards. Senator Elizabeth Warren said that the bill had been "hijacked" by the pharmaceutical industry. She said the legislation watered down safety requirements for new drugs and devices and then, as a trade-off, called for research funding -- at levels that must be appropriated on an annual basis. John LaMattina, former head of Pfizer research and development and current commentator on the pharmaceutical industry, said that full clinical trials are necessary to prove effectiveness, and suggests some drugs may now be approved based on early data and only later proved ineffective. The Public Citizen's Health Research Group says the designation of "breakthrough" devices is too broad, and could lead to clearance of devices that aren't ready for the market.
Lupkin points out that the NIH's funding will need to be appropriated each year through the normal budget process, and therefore may be reduced from what this bill promised. The NIH funding was actually less than many advocates hoped for, and earlier versions of the bill had promised.
See also
- BRAIN Initiative
- Cancer Moonshot 2020
- Precision Medicine Initiative
References
External links
- Official website
- "21st Century Cures". United States House of Representatives: Energy and Commerce Committee. 14 December 2016.
- "21st Century Cures: A Call to Action" (PDF). United States House of Representatives: Energy and Commerce Committee. 1 May 2014.
- "Discussion Document 114th Congress, 1st Session: To accelerate the discovery, development, and delivery of 21st century cures, and for other purposes" (PDF). United States House of Representatives: Energy and Commerce Committee. 26 January 2015.
- "The 21st Century Cures Discussion Document" (PDF). United States House of Representatives: Energy and Commerce Committee. 27 January 2015.
- Hudson, Kathy L.; Collins, Francis S. (12 January 2017). "The 21st Century Cures Act -- A View from the NIH". New England Journal of Medicine. 376 (2): 111-113. doi:10.1056/NEJMp1615745 . ISSN 0028-4793. PMID 27959585.
- Avorn, Jerry; Kesselheim, Aaron S. (25 June 2015). "The 21st Century Cures Act -- Will It Take Us Back in Time?". New England Journal of Medicine. 372 (26): 2473-2475. doi:10.1056/NEJMp1506964 . ISSN 0028-4793. PMID 26039522.
- Stone, Judy (22 September 2016). "21st Century Cures Act: Pork or Promise?". Forbes.
- "We Support the 21st Century Cures Act". National Health Council. 25 June 2015.
- Obama, Barack (3 December 2016). "Weekly Address: Pass the 21st Century Cures Act" (Press release). Washington, DC: The White House, Office of the Press Secretary.
- Alden (19 February 2015). "21st Century Cures: Improving the cycle from discovery to treatment". Cure Alliance for Mental Illness.
- Gionfriddo, Paul (15 December 2016). "Why the New Mental Health Reform Law Passed, and What It Means to Me". Mental Health America.
- Lupkin, Sydney (28 November 2016). "A Frenzy Of Lobbying On 21st Century Cures". Kaiser Health News. Kaiser Family Foundation.
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