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 (PDF, 3.9 MB), each year in the United States at least two million people develop serious infections caused by bacteria resistant to antibacterial drugs, and at least 23,000 people die as a result. Combating AMR requires multifaceted efforts in both the healthcare and veterinary sectors.
Image: Scanning electron micrograph of methicillin-resistant Staphylococcus aureus (MRSA, brown) surrounded by cellular debris. MRSA resists treatment with many antibiotics. (Credit: NIAID disclaimer icon)
September 14, 2018: Remarks from FDA Commissioner Scott Gottlieb, M.D., on FDA’s strategic approach for combating antibiotic resistance at an event disclaimer icon hosted by The Pew Charitable Trusts
September 14, 2018: FDA Releases Five-Year Plan for Supporting Antimicrobial Stewardship in Veterinary Settings – FDA’s Center for Veterinary Medicine (CVM) unveiled its five-year action plan for supporting antimicrobial stewardship in veterinary settings – Also see: Supporting Antimicrobial Stewardship in Veterinary Settings: Goals for Fiscal Years 2019-2023 (PDF, 282 KB)
September 11, 2018: Development of New Antibacterial Drugs Active Against Multi-Drug Resistant Bacteria – The FDA Center for Drug Evaluation and Research (CDER) Office of Antimicrobial Products has issued a Request for Information (RFI) to solicit informal input from the public and private sectors to obtain external input into developing an annual list of regulatory science initiatives specific for antimicrobial products. Respond by October 31, 2018.
August 28, 2018: FDA approved Xerava (eravacycline), a tetracycline class antibacterial drug, for the treatment of complicated intra-abdominal infections (cIAI) caused by certain microorganisms. Product label (PDF, 194 KB) – Also see Drug Trial Snapshot: XERAVA, posted September 18, 2018
July 31, 2018: Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new efforts to advance antimicrobial stewardship in veterinary settings
July 10, 2018: FDA/CDRH cleared the first of three devices for antimicrobial susceptibility testing (AST) of Plazomicin.
June 12, 2018: Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s efforts to foster discovery and development of new tools to fight antimicrobial-resistant infections
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.
As more bacteria grow resistant to antibiotics, we must tackle the issue on all fronts and seek new approaches to this persistent and potentially deadly problem. – Scott Gottlieb, MD, FDA Commissioner
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.
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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.
Employing product development program and incentives
Encouraging the development of novel and nontraditional products, and new tools
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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.