21st Century Cures

The 21st Century Cures Act (P.L. 114-255) is landmark, bipartisan legislation that was signed into law on Dec. 13, 2016, and touches virtually all aspects of biomedical research, medical product development and the regulatory approval process. Read what FasterCures has said about 21st Century Cures over the years.

FasterCures worked closely with Congress, federal agencies and the advocacy community throughout the legislation’s journey to the president’s desk. In February 2017, we debuted the 21st Century Cures Tracker to track the implementation of the 100+ sections in Division A, which include the key provisions relevant to biomedical research and innovation. (Other divisions of the law pertain to mental health and Medicare; since those are not areas of focus for FasterCures, we will not be actively tracking them here.) Learn more about how to use the tracker with our FAQs page.

A few examples of the issues we will be tracking include the impact of changes to the National Institutes of Health’s administrative requirements for grantees, how the Food and Drug Administration implements new changes designed to enhance patient engagement and how the Department of Health and Human Services is using its new authorities to promote health information technology interoperability.

Many external factors will affect the progress of these initiatives, including policies related to hiring freezes and uncertain funding levels. This tracker is not meant to be a pass/fail report card, but rather a snapshot in time that can help explain impact and identify where progress is needed.

Please keep coming back, as we will be updating the information regularly. Use the button below to send us feedback on the value of the information we are presenting, and the usability of this new resource.

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FasterCures' 21st Century Cures Act Tracker (P.L. 114-255)

Status Section Tracked Deadlines and Requirements Update Date of Update Tags
fa fa-2x fa-long-arrow-right Sec. 3041. Antimicrobial resistance monitoring. 12/13/2017, and annually thereafter: requires FDA and CDC to issue reports addressing national trends in antimicrobial use and resistance to those drugs.

10/4/2017: The CDC released a report on national trends in antimicrobial use and resistance entitled "2017 Antibiotic Use in the United States: Progress and Opportunities."

20171010 10/10/2017 CDC, FDA, HHS, Infectious Disease, Reports
fa fa-2x fa-long-arrow-right Sec. 3042. Limited population pathway. Creates a new pathway for FDA to approve antibacterial and antifungal drugs based for limited populations, using a benefit-risk profile specific to that population.
6/13/2018: requires FDA to issue draft guidance describing this pathway and related processes.
At least every 2 years, FDA must report to Congress on the applications and approvals under this program.
12/31/2021: requires GAO issuance of a report on this program.

8/14/2019: FDA announced the approval of a new drug for treatment-resistant forms of tuberculosis, making it the second drug approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs.

4/2/2019: FDA announced a public meeting entitled "Limited Population Pathway for Antibacterial and Antifungal Drugs" to provide a public forum for FDA to listen to comments on the draft guidance for industry, "Limited Population Pathway for Antibacterial and Antifungal Drugs." FDA has reopened the comment period for further opportunities to inform the final guidance, and may be submitted electronically until August 12, 2019.

9/28/2018: FDA approves its first drug, Arikayce, under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD).

6/13/2018: FDA announced the availability for comment of draft guidance "Limited Population Pathway for Antibacterial and Antifungal Drugs"

20190815 08/15/2019 FDA, GAO, Infectious Disease, Regulatory Affairs, Reports
fa fa-2x fa-check Sec. 3043. Prescribing authority. Clarifies that nothing in this section restricts the authority of healthcare providers to prescribe antimicrobial drugs or products. In effect upon enactment.
Complete. 20161213 12/13/2016 FDA, Infectious Disease
fa fa-2x fa-long-arrow-right Sec. 3044. Susceptibility test interpretive criteria for microorganisms; antimicrobial susceptibility testing devices. 12/13/2017: instructs FDA to establish and regularly maintain a website that lists appropriate interpretive criteria standards for antimicrobial drug susceptibility assays.
12/13/2018: requires FDA to submit a report to Congress on implementation of this provision.

12/13/2017: FDA announced the establishment of web resource, "FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria" 

20171213 12/13/2017 FDA, Infectious Disease, Regulatory Affairs, Reports
fa fa-2x fa-check Sec. 3093. Encouraging vaccine innovation. 12/13/2017: requires HHS to submit a report to Congress on promoting innovation in infectious disease vaccine development.

4/4/2018: HHS is seeking comment on a proposed amendment to the National Vaccine Injury Compensation Program (VICP) Vaccine Injury Table to include vaccines recommended by the Centers for Disease Control and Prevention (CDC) for routine administration in pregnant women.

2/8/2018: The National Vaccine Advisory Committee held a public meeting on February 7 & 8, 2018. Sessions consisted of presentations on vaccine innovation, including the current status of adjuvants in vaccines, universal influenza, and an overview on the Secretary of the Department of Health and Human Services' Report to Congress on Vaccine Innovation in response to the 21st Century Cures Act. Recording available here

6/8/2017: The National Vaccine Advisory Committee 2017 meeting on June 6 and June 7 with include an update on the the Secretary of the Department of Health and Human Services' report on vaccine innovation required by this section and other themes related to encouraging vaccine innovation. Information on the final meeting agenda will be posted prior to the meeting on the NVAC website.

20180404 04/04/2018 BARDA, CDC, FDA, HHS, Infectious Disease, NIH, Reports, Vaccines


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