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Implications of the 21st Century Cures Act on Antibiotic Drug Development

In addition to LPAD, the Cures Act encourages widespread monitoring for antibiotic resistance and increased efforts to reduce inappropriate uses of antibiotics. The legislation establishes a mechanism for healthcare facilities at the Department of Defense, Department of Veterans Affairs, and Indian Health Services to routinely report and evaluate aggregate antibiotic resistance rates within each facility. Healthcare facilities, such as hospitals, nursing homes, and outpatient clinics will also receive educational materials and guidance to support implementation of antibiotic stewardship programs. Importantly, an annual public report will be issued that summarizes national and regional trends in antibiotic resistance, as well as progress on stewardship activities. The first report is expected this year.
Lastly, the Cures Act includes provisions to help improve the availability of information on pathogen susceptibility to a given antibiotic (interpretive susceptibility criteria or “breakpoints”) and keep breakpoints up-to-date. Specifically, any new or updated interpretive susceptibility criteria standards will be evaluated every 6 months. Such an infrastructure may better enable clinicians to select antibiotics that are most likely to lead to positive clinical outcomes for their patients, as well as ensure consistency in methodologies used to establish breakpoints across all antibiotics and antibiotic classes regardless of the date of approval. Furthermore, break-points will be posted to a website, which will be established this year, and a reference or hyperlink to the site will be included in the FDA-approved package insert.5 A deeper understanding of the antibiotic resistance landscape and more frequent review of breakpoints will position clinicians, drug developers, scientists, and the FDA to more appropriately address the rising tide of resistance and optimize patient care.
In summary, several key sections of the Cures Act impact antimicrobial development and clinical use. The language in the legislation supports more stringent resistance monitoring and stewardship activities aimed at combating resistance. Most notably, LPAD represents both a congressional acknowledgment of the public health crisis and significant progress in the formation of a clinical-regulatory pathway that enables drug companies to develop antibiotics for patient populations that currently have unmet medical needs.
Dr. Stork is a senior associate in Regulatory Affairs at Achaogen. She completed her PhD in molecular biology at Stanford University.
Dr. Komirenko is a clinical sciences fellow at Achaogen. She completed her PharmD at the University of California, San Francisco. She is an active member of the Society of Infectious Disease Pharmacists (SIDP).
Dr. Mohr is vice president of Medical Affairs at scPharmaceuticals and president and founder of Medical Affairs Strategic Solutions. He is an active member of SIDP.
Dr. Boucher is associate professor of medicine at Tufts University School of Medicine and director of the Infectious Diseases Fellowship Program and Tufts Medical Center. She is an active member of SIDP.

  1. Centers for Disease Control and Prevention. Antibiotic/antimicrobial resistance. CDC website. Updated March 8, 2017. Accessed March 10, 2017.
  2. Projan SJ, Shlaes DM. Antibacterial drug discovery: is it all downhill from here? Clin Microbiol Infect. 2004;10(suppl 4):18-22.
  3. Shore C. The importance of better drug design for antibiotic innovation. The Pew Charitable Trusts website. Published March 8, 2017. Accessed March 10, 2017.
  4. 21st Century Cures Act. H.R. 34, 114th Cong. (2015).
  5. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for industry: antibacterial therapies for patients with unmet medical need for the treatment of serious bacterial diseases. FDA website. Published July 26, 2013. Accessed March 10, 2017.
  6. Califf RM. 21st Century Cures Act: making progress on shared goals for patients. FDA website.

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