21st Century Cures Act

The 21st Century Cures Act is a United States law enacted by the 114th United States Congress in December 2016.wikipedia
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114th United States Congress

114th Congress114thUnited States Congress
The 21st Century Cures Act is a United States law enacted by the 114th United States Congress in December 2016.

Informed consent

consentPrior Informed Consentconsensual
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."
The 21st Century Cures Act enacted by the 114th United States Congress in December 2016 allows researchers to waive the requirement for informed consent when clinical testing "poses no more than minimal risk" and "includes appropriate safeguards to protect the rights, safety, and welfare of the human subject."

Fred Upton

Frederick Stephen UptonRep. Fred Upton (R, MI-6)Rep. Fred Upton
Another bill with the same name, was introduced by Fred Upton (R–MI) on May 19, 2015.
On December 13, 2016, President Obama signed Upton's 21st Century Cures Act into law.

Beau Biden

BeauJoseph R. "Beau" Biden IIIJoseph Robinette "Beau" Biden III
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.
A portion of the 21st Century Cures Act (2016) was named the "Beau Biden Cancer Moonshot" initiative after him.

Jeff Merkley

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.
In December 2016 Merkley was one of five senators to vote against the Obama administration-supported 21st Century Cures Act, legislation increasing funding for disease research while addressing flaws in the American mental health systems and altering drugs and medical devices' regulatory system."

All of Us (initiative)

Precision Medicine InitiativeAll of UsAll of Us Initiative
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.

Genetic privacy

genetic datagenetic information privacyprivacy of genetic information
The American Society of Human Genetics (ASHG) commended the passage of the bill for strengthened genetic privacy for research participants.
Privacy protections for genetic research participants were strengthened by provisions of the 21st Century Cures Act (H.R.34) passed on 7 December 2016 for which the American Society of Human Genetics (ASHG) commended Congress, Senator Warren and Senator Enzi.

Prison Fellowship

Wilberforce ForumJustice Fellowship
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.
Prison Fellowship has worked with members of Congress to pass the following pieces of criminal justice reform legislation: the Religious Freedom Restoration Act (1993), the Religious Land Use and Institutionalized Persons Act (2000), the Prison Rape Elimination Act (2003), the Second Chance Act (2008), the Fair Sentencing Act (2010), and the 21st Century Cures Act (2016) as well as a variety of state-level criminal justice reforms.

Cancer Breakthroughs 2020

Cancer Moonshot 2020Cancer Moonshotnational effort

National Institutes of Health

NIHNational Institute of HealthNational Institutes of Health (NIH)
It authorized $6.3 billion in funding, mostly for the National Institutes of Health. 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.

Pharmaceutical industry

pharmaceutical companypharmaceuticalpharmaceutical companies
The act was supported especially by large pharmaceutical manufacturers and was opposed especially by consumer organizations.

Consumer organization

consumer advocacyconsumer organisationconsumer group
The act was supported especially by large pharmaceutical manufacturers and was opposed especially by consumer organizations.

Opioid

opioidsopioid-induced constipationopioid analgesic
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.

Comprehensive Addiction and Recovery Act

Comprehensive Addiction and Recovery Act (CARA)
The Comprehensive Addiction and Recovery Act (CARA) was passed a few months earlier.

Naloxone

NarcanNaloxone hydrochlorideEvzio
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.

Prescription monitoring program

prescription drug monitoring programchanges to prescription-writingIllinois Prescription Drug Monitoring Program
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.

Substance dependence

addictiondependencedrug dependence
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.

Drug development

developmentdevelopedclinical development
The 21st Century Cures Act modified the FDA Drug Approval process.

Food and Drug Administration

FDAU.S. Food and Drug AdministrationUnited States Food and Drug Administration
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.

Observational study

observational studiesobservationalobservational data
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.

Institutional review board

Institutional Review BoardsInstitutional Review Board (IRB)IRB
Researchers will still need to obey standard research protocols including institutional review boards to approve their research design and ethics.

Joe Biden

Joseph BidenBidenVice President Joe Biden
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.

Brain tumor

brain cancerbrain tumourbrain tumors
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 (United States)

Strategic Petroleum ReserveStrategic Petroleum ReservesUS Strategic Petroleum Reserve
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.

Health Insurance Portability and Accountability Act

HIPAAHealth Insurance Portability and Accountability Act of 1996Health Insurance Portability and Accountability Act (HIPAA)
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.