[4][5] 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.
This act authorized many harm-reduction strategies, including increased access to the overdose reversal drug naloxone[7] for the opioid crisis, but didn't provide any federal funding for implementation.
[8] The 21st Century Cures Act designated $1 billion in grants for states over two years to fight the opioid epidemic.
[12] 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.
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.
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."
"[12] The act allocates $4.8 billion to the National Institutes of Health for precision medicine and biomedical research.
[clarification needed][citation needed] 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.
[citation needed] 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.
It also includes grants to provide community mental health resources, suicide prevention and intervention programs, and de-escalation training for law enforcement.
[8] It also provides five-year grants for a demonstration program in which psychiatry residents and other mental health clinicians will practice in underserved areas.
[30] 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.
[37] 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.
[41] 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.
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.
[10] 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.