21st Century Cures Act
Science, Space, and Technology; Commerce, Science, and Transportation on December 13, 2016 |
The 21st Century Cures Act is a United States law enacted by the
The approval of drugs and devices would be streamlined, according to supporters, and treatments would reach the market more quickly. The argument made by opponents was that it would allow the marketing of riskier or less effective treatments by allowing the approval of drugs and devices on the basis of flimsier evidence, bypassing randomized, controlled trials.[3]
The bill incorporated the Helping Families In Mental Health Crisis Act, first introduced by then-Congressman Tim Murphy, R-Pa., which increased the availability of psychiatric hospital beds and established a new assistant secretary for mental health and substance use disorders.[4][5]
Content
Research and drug development
Division A, titled "21st Century Cures," contains provisions related to National Institutes of Health funding and administration, reducing opioid abuse, medical research, and drug development.[6]
Opioid epidemic
The
FDA drug approval process
The 21st Century Cures Act modified the
Targeted drugs for rare diseases
The 21st Century Cures Act facilitates the development and approval of genetically targeted and variant protein targeted drugs for treatment of rare diseases.[12]
Informed consent
In section 3024, the 21st Century Cures Act allows researchers to waive the requirement for "informed consent" in cases where clinical testing of drugs or devices "poses no more than minimal risk" and "includes appropriate safeguards to protect the rights, safety, and welfare of the human subject."[12]
One example is a high-tech bandage that monitors blood flow. Standard procedure requires researchers to obtain the patient's permission before testing any new device on them. However, in this example, researchers might want to test the bandage on unconscious patients. In such circumstances, researchers may waive an informed consent requirement since the patient is still getting the standard, medically accepted care of blood pressure and heart rate monitoring. Researchers would still need to obey standard research protocols including
Human research subject protections
The 21st Century Cures Act calls on the Secretary of Health and Human Services to harmonize differences between the HHS Human Subject Regulations and FDA Human Subject Regulations. In so doing, the Secretary may change rules applying to vulnerable populations in order "to reduce regulatory duplication and unnecessary delays" and "modernize such provisions in the context of multisite and cooperative research projects."
Section 3023 provides for joint or shared review of research, review by institutional review boards other than that of the sponsor of research, and use of other means "to avoid duplication of effort."[12]
Medical research
The act allocates $4.8 billion to the
When Joe Biden became president, his administration revived the cancer initiative. On the 60th anniversary of the John F. Kennedy moonshot speech, President Biden gave a speech at the JFK library, promoting the revival of the Beau Biden Cancer Moonshot, including the new Advanced Research Projects Agency for Health.[18]
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.[19][20] Revenue from these sales will provide part of the NIH funding provided in the law.[21]
Electronic health records information blocking
The Act defined interoperability and prohibited[22] information blocking.[23] Information blocking is defined as a practice that interferes with or prevents access to electronic health information, that is, information about a patient's medical history or treatment.[12][24]
Under section 4004, information blocking can expose entities to fines of up to $1 million per violation.[12]
Medical software
Medical software is regulated as a medical device by the FDA in the Federal Food, Drug, and Cosmetic Act.[25] Section 3060 of the 21st Century Cures Act was created as an amendment to section 520 of the FD&C Act, which addressed how medical devices are defined.[26][27] It outlined software functions that would be exempt from FDA regulation, such as those used for administrative purposes, encouraging a healthy lifestyle, electronic health records, clinical laboratory test results and related information, and clinical decision tools.[6][28]
Behavioral health
Division B, titled "Helping Families in Mental Health Crisis," 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.[29]
The law strengthens
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).[30]
Healthcare access and quality improvement
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Division C, titled "Increasing Choice, Access, and Quality in Health Care for Americans," concerns Medicare programs and federal tax laws related to health plans for small employers.[31]
The Small Business HRA (QSEHRA)
The 21st Century Cures Act also included provisions that created a QSEHRA (Qualified Small Employer Health Reimbursement Arrangement), a more efficient way for small businesses and non-profits to offer health insurance to their employees.
Legislative history
The 21st Century Cures Act was originally introduced as H.R. 6 by Fred Upton (R–MI) on May 19, 2015. It passed the House on July 10, 2015, but did not pass in the Senate.[32][33]
More than 1,400 registered lobbyists worked on this bill, representing more than 400 different organizations,[11] mostly pharmaceutical companies.[10]
Of 455 organizations registered to lobby on the bill, the top five by number of reports and specific issues according to OpenSecrets were:
- Roche Holdings(61)
- Blue Cross Blue Shield (49)
- Pharmaceutical Research and Manufacturers of America PhRMA (49)
- Amgen (41)
- American Hospital Association (36).[34]
The bill passed the House first by a wide margin.[35] 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.[36] Warren, Sanders, and Merkley, in particular, objected to the pharmaceutical industry's influence on the bill.[2] In early December 2016, the act had support from both houses of congress.[37][38]
President Obama signed the act on December 13, 2016.
Reception
Stakeholders who praised the passing of the act include drug companies;
Stakeholders who criticized the passing of the act include the
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.[11] The NIH funding was actually less than many advocates hoped for,[10][11] and earlier versions of the bill had promised.[citation needed]
One of the goals of the bill was streamlining approval, but Jerry Avorn and Aaron Kesselheim pointed out that a third of medicines are approved from a single clinical trial averaging fewer than 700 patients;[46] ultimately, however, the law did not allow real-world evidence for approving drugs, but rather for label expansions.[47]
See also
- BRAIN Initiative
- Cancer Moonshot 2020
- Precision Medicine Initiative
References
- ^ a b c d e "Learn from Cures Act bipartisanship". Editorial. Asbury Park Press. Asbury Park, NJ: Gannett. 17 December 2016. Retrieved 31 December 2016.
- ^ a b Mukherjee, Sy (7 December 2016). "Everything You Need to Know About the Massive Health Reform Law That Just Passed Congress". Fortune. Retrieved 14 December 2016.
- ^ With media watchdogs on the sidelines, pharma-funded advocacy groups pushed Cures Act to the finish line. Trudy Lieberman, HealthNewsReview, December 6, 2016
- ^ Congress Is on the Verge of Passing a Landmark Mental Health Bill
- ^ "House Passes Most Significant Mental Health Reform Bill in Decades". NBC News. 17 July 2016. Archived from the original on 2022-12-25.
- ^ a b H.R. 34 Division A—21st Century Cures
- ^ "The Comprehensive Addiction and Recovery Act (CARA)". Community Anti-Drug Coalitions of America. Retrieved 14 October 2020.
- ^ a b c d e f g h Jacoby, Sarah (December 16, 2016). "What The Controversial 21st Century Cures Act Means For You". Refinery29. Retrieved 31 December 2016.
- ^ .
- ^ a b c d e f g h i j k Kaplan, Sheila (5 December 2016). "Winners and losers of the 21st Century Cures Act". STAT News. Retrieved 31 December 2016.
- ^ a b c d e f Franz, Julia (December 25, 2016). "America's new 21st Century Cures Act will speed up drug approvals. Is that a good thing?". PRI. Retrieved 2016-12-31.
- ^ a b c d e "PUBLIC LAW 114–255—DEC. 13, 2016" (PDF). www.govinfo.gov. U.S. Government Publishing Office. Retrieved 2 October 2021.
- ^ Biden, Joe; Obama, Barack (13 December 2016). "Remarks by the President and the Vice President at the 21st Century Cures Act Bill Signing" (Press release). Washington, DC: The White House, Office of the Press Secretary. Retrieved 31 December 2016.
- ^ "AACR Commends President Obama for Signing the 21st Century Cures Act" (Press release). Philadelphia, PA: American Association for Cancer Research. 13 December 2016. Retrieved 2016-12-31.
- ^ "All of Us (project web page)". U.S. Department of Health & Human Services - National Institutes of Health. 2018. Retrieved 20 January 2018.
- ^ Muoio, Dave (7 November 2017). "Fitbit wearables will help power NIH's All of Us Research Program". MobiHealthNews. Retrieved 20 January 2018.
- ^ "NIH Partners With 14 Community Groups, Healthcare Associations on Outreach for All of Us Program". GenomeWeb. 17 November 2017. Retrieved 20 January 2018.
- ^ Jessica Bartlett (September 12, 2022). "Channeling JFK in Boston visit, Biden breathes new life into cancer 'moonshot'". The Boston Globe.
- ^ "This Week in Petroleum". US Department of Energy. 21 December 2016. Retrieved 21 December 2016.
- ^ H.R. 34, Sec. 5010. Strategic Petroleum Reserve Drawdown.
- ^ Lupkin, Sydney (25 November 2016). "Legislation That Would Shape FDA And NIH Triggers Lobbying Frenzy". Shots: Health News from NPR. National Public Radio.
- ^ 21st Century Cures Act, 42 USC § 300jj-52(a)(1)(A) (2016).
- PMID 30134128.
- ^ "What is an electronic health record (EHR)? | HealthIT.gov". www.healthit.gov. Retrieved 2 October 2021.
- ^ Health, Center for Devices and Radiological (2020-09-09). "What are examples of Software as a Medical Device?". FDA.
- ^ Guidance for Industry and Food and Drug Administration Staff. "Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act". Food and Drug Administration.
- ^ Health, Center for Devices and Radiological (2019-09-30). "Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act". U.S. Food and Drug Administration. Retrieved 2020-12-05.
- S2CID 52006753.
- ^ H.R. 34 Division B—Helping Families in Mental Health Crisis
- ^ "H.R. 34 (114th): 21st Century Cures Act". GovTrack. Civic Impulse, LLC. Retrieved January 10, 2017.
- ^ H.R. 34 Division C—Increasing Choice, Access, and Quality in Health Care for Americans
- ^ "Actions - H.R.6 - 114th Congress (2015-2016): 21st Century Cures Act". Congress.gov. Library of Congress. July 13, 2015. Retrieved 2017-01-10.
- ^ "21st Century Cures Act (Public Law 114-255)". SciPol.org. 2016-12-14. Retrieved 2020-12-05.
- ^ "Lobbying Spending Database H.R.6 , 2014 | OpenSecrets".
- ^ Kaplan, Sheila (30 November 2016). "House approves the 21st Century Cures Act, sending landmark bill to Senate". Stat.
- ^ Roll call vote 157, via Senate.gov
- ^ Pear, Robert (8 December 2016). "Cures Act Gains Bipartisan Support That Eluded Obama Health Law". The New York Times. Retrieved 14 December 2016.
- ^ Ornstein, Norm (2015-07-13). "Congress Achieves a Rare Bipartisan Victory for Science". The Atlantic. Retrieved 2016-12-14.
- ^ National Archives.
- ^ Sliwa, Jim (1 December 2016). "APA Hails House Passage Of Mental Health Provisions In 21st Century Cures Act" (Press release). Washington, DC: American Psychological Association. Retrieved 31 December 2016.
- ^ Padmanabhan, Nalini (7 December 2016). "ASHG Supports Genetic Privacy Provisions in 21st Century Cures Act" (Press release). Bethesda, MD: American Society of Human Genetics. Retrieved 2 January 2017.
- ^ Thompson, Dennis (8 December 2016). "Congress passes 21st Century Cures Act with billions for new research, treatments". CBS News. CBS Interactive Inc. Retrieved 2 January 2017.
- ^ Enzi, Mike (15 December 2016). "Congress acts to protect the most personal data – genetic information". Opinion. Pine Bluffs Post. Vol. 108, no. 50. Pine Bluffs, WY. Retrieved 2 January 2017.
- ^ DeRoche, Craig (29 November 2016). "Urgent need for support for 21st Century Cures Act". PrisonTalk.com. Retrieved 22 February 2017.
- ^ DeRoche, Craig (14 December 2016). "Dear Scotty". New Abolitionists Radio. Retrieved 22 February 2017.
- PMID 26039522.
- ^ "The Politics of the 21st Century Cures Act". In the Pipeline. 2016-12-09. Retrieved 2018-11-25.
- "21st Century Cures". United States House of Representatives: Energy and Commerce Committee. 14 December 2016. Archived from the original on 24 December 2016. Retrieved 22 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.; 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. 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.
External links
- 21st Century Cures Act as amended (PDF/details) in the GPO Statute Compilations collection
- 21st Century Cures Act as enacted (PDF/details) in the US Statutes at Large
- H.R. 34 on Congress.gov
- Health and Human Services Department's final rule on 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program in the Federal Register
- Cures Act Final Rule website from the ONC