21st Century Cures Act
The 21st Century Cures Act is a major health care and research reform package with strong bipartisan support passed by Congress today, December 7, 2016. According to The Hill, it is expected to be signed into law by the President very quickly. Passage of the Act is considered a victory for biomedical researchers, pharmaceutical companies and patients. In addition to mental health and opioid addiction aid and provisions affecting patients, the Act contains several features important to the biomedical research community, including measures intended to advance research and expedite approval for lifesaving cures.
Highlights of the “Cures” Act include an authorization for increased funding for the National Institutes of Health (NIH), acceleration of the Food and Drug Administration (FDA) drug approval process, and prioritization for the development of innovation projects that support research discovery at the NIH and FDA. It also provides for the review of regulations and policies affecting researchers using animal models, with an emphasis on reducing administrative and regulatory burden.
The Act authorizes the following funding for biomedical research, although actual appropriations are still required and may vary annually.
- $4.796 billion of funding for the National Institutes of Health (FY 2017-2026)
- $1.8 billion for cancer research (FY 2017-2023)
- $1.511 billion for BRAIN (FY 2017-2026)
- $1.455 billion for the Precision Medicine Initiative (FY 2017-2026)
- $500 million of funding for the FDA (FY 2018-2026)
- $30 million for regenerative medicine research using adult stem cells (FY 2017-2020)
AWARD OF RESEARCH GRANTS:
The Act simplifies the application and approval process for researchers and reduces burdens on recipients.
Specifically, the Act provides for the following provisions related to NIH grants—
- Implement measures to reduce burdens on the monitoring of subrecipients of grants, including an exemption from subrecipient monitoring or the implementation of alternative grant structures which remove the need for such monitoring.
- Establish considerations to modify the timelines for the reporting of financial conflicts of interest and ensure they are appropriate for the award.
- Avoid duplication of procedures and requirements between the agency and the department, requiring the Secretary of Health & Human Services (HHS) and the Director of the NIH to evaluate expenditure reporting to minimize burdens on funding recipients.
- Creates the “Next Generation of Researchers Initiative” to foster a new crop of investigators. The Initiative will promote research independence and increase opportunities for funding and mentorship, and will enhance workforce diversity for young researchers.
DRUG APPROVAL PROCESS:
FDA is granted authority by the Emergency Use Authorization (EUA) to strengthen the nation’s response to chemical, biological, radiological, or nuclear (CBRN) threats through the use of unapproved medical products. 21st Century Cures clarifies this authorization by allowing the use of conditionally approved medications. It also expands the use of these unapproved countermeasures to animal drugs and animals.
REDUCTION OF REGULATORY BURDEN:
The Act aims to reduce administrative and regulatory burden for biomedical researchers. Two other bills (H.R. 5583 and S. 2742) were previously introduced in the 114th Congress to alleviate regulatory burden in research, but no action was taken. The language of the “Cures” Act states in Sec. 2034, page 69 that not later than 2 years after enactment, “the NIH Director shall collaborate with the Agriculture Secretary and Food and Drugs Commissioner to complete a review of the policies and regulations for the care and use of laboratory animals. As appropriate, they shall revise and reduce burden placed on investigators, while protecting research animals and maintaining the integrity and credibility of research findings.”
The Director of the NIH shall seek input of experts and shall—
- “Identify ways to ensure such regulations and policies are not inconsistent, overlapping, or unnecessarily duplicative, including with respect to inspection and review requirements by Federal agencies and accrediting associations;
- Take steps to eliminate or reduce identified inconsistencies, overlap, or duplication among such regulations and policies; and
- Take other actions, as appropriate, to improve the coordination of regulations and policies with respect to research with laboratory animals.”
The Act also provides for a review by research funding agencies regarding the policies covering the disclosure of financial conflicts of interest and make any revisions necessary to harmonize these policies.
RESEARCH POLICY BOARD:
One year after enactment, a research policy board will be established to advise government officials about the effects of regulations on researchers. The board will consist of the Administrator of the Office of Information and Regulatory Affairs of the Office of Management and Budget, the Director of the Office of Science and Technology Policy, the Secretary of HHS, the Director of the National Science Foundation, and other secretaries and directors that support or regulate scientific research, as well as 9 and 12 members from nonprofit scientific organizations. The board will conduct assessments of regulatory policies and offer suggestions for improvement. The board will then submit a report to selected federal offices and Congressional committees containing their formal recommendations.
The House Appropriations Committee has introduced a continuing resolution (CR) that will fund the government at its current spending levels through April 28, 2017. The current $1.07 trillion budget cap level will be maintained.
The CR will provide $872 million for biomedical research in 2017, which serves as the first installment of National Institutes of Health (NIH) funding in the 21st Century Cures Act, a landmark healthcare reform bill passed today by the Senate that is headed to the President’s desk for his signature. Of this funding, $352 million will be allocated to the NIH for innovation purposes, $500 million to states for grants to tackle opioid abuse and addiction, and $20 million to the Food and Drug Administration to modernize regulations.
As stated in Section 1001 of the CR, allocations for 2017 NIH innovation funds are broken down as follows:
- $300 million for cancer research
- $40 million for the Precision Medicine Initiative
- $10 million for BRAIN
- $2 million for regenerative medicine research using adult stem cells
In addition, the CR provides disaster assistance and relief for those affected by contaminated drinking water such as the Flint, Michigan community. It also provides funding to the Defense and State Departments to combat terrorism, as well as a waiver for the requirement that the Secretary of Defense be a civilian for 7 years before being nominated and confirmed as Secretary of Defense.
The bill is being reviewed by the House Rules Committee this afternoon. It is expected that the House will vote on Thursday, followed by a Senate vote on Friday. The CR must be passed by both chambers and signed by the President before December 9th which is when the current spending bill expires.
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