Antimicrobial resistance (AMR)—the ability of a microorganism (bacteria, virus, fungi, parasite) to resist the effects of a drug—is a serious, complex and costly public health problem.
According to the Centers for Disease Control and Prevention, each year in the United States at least 2.8 million antibiotic-resistant infections occur, and more than 35,000 people die as a result. Combating AMR requires multifaceted efforts in both the healthcare and veterinary sectors.
The FDA’s role and strategic approach
Antimicrobial resistance is recognized as a growing global threat. In 2014, the White House announced the National Strategy for Combating Antibiotic-Resistant Bacteria (CARB), underscoring the need for a coordinated inter-agency response to this threat. The FDA has been and continues to be integral in these efforts.
Several of FDA’s Centers—including the Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), Center for Biologics Evaluation and Research (CBER), Center for Veterinary Medicine (CVM), National Center for Toxicological Research (NCTR), and the Office of the Chief Scientist—play key roles in combating AMR.
The FDA is dedicated to addressing the challenges AMR presents by helping to preserve the effectiveness of currently available antimicrobial drugs and promoting the development of new medical products that can help reduce the emergence and spread of AMR bacteria.
Working with both domestic and international partners, the FDA is proactively addressing the complex challenges associated with the growing threat of AMR by:
- Facilitating efficient product development to address AMR, including the development of new antimicrobials, diagnostic tests, and vaccines
- Promoting the appropriate and responsible use of antimicrobials and disseminating information promoting interventions that help slow the development of resistance
- Supporting the development and enhancement of tools for conducting surveillance of antimicrobial use and resistance so stakeholders can better track, treat, or respond to AMR outbreaks
- Advancing regulatory science to develop the tools, standards, and approaches to facilitate the translation of breakthrough discoveries in science and technology into innovative, safe, and effective medical products
To achieve this mission, the FDA will continue to work collaboratively with Congress, its partners at other U.S. government agencies, and other stakeholders to find additional ways to prevent, detect, and address AMR.
Product development
The FDA works closely with product sponsors and other government agencies to facilitate efficient product development to address AMR, including new antimicrobial drugs, biologics (including human vaccines), and diagnostics.
Antimicrobial stewardship
The FDA works closely with domestic and international partners to promote the judicious use of antibiotics in the veterinary setting and complements the work done by other government agencies in the human healthcare setting.
Surveillance and monitoring of antimicrobial use and resistance
The FDA works in close coordination with interagency partners and domestic stakeholders to collect the data necessary to conduct surveillance and monitoring of antimicrobial use and resistance.
Regulatory science
The FDA supports regulatory science to develop the tools, standards, and approaches to facilitate the translation of breakthrough discoveries in science and technology into innovative, safe, and effective medical products.
The 2022: Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science (FARS) report outlines topics FDA has identified as needing continued targeted investment in regulatory science research to facilitate development of innovative products, provide data and methods to inform regulatory decision-making, and improve guidance to sponsors. Antimicrobial resistance is a priority area, under the focus area “Public Health Preparedness and Response.” Please contact [email protected] with questions about this initiative.
Source: https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/antimicrobial-resistance
