Antimicrobial Resistance Information from FDA
![Scanning electron micrograph of methicillin-resistant Staphylococcus aureus (MRSA, brown) surrounded by cellular debris. MRSA resists treatment with many antibiotics. Credit: NIAID](https://public4.pagefreezer.com:443/content/FDA/23-03-2022T15:36/https://www.fda.gov/files/styles/main_image_medium/public/MRSA_1600px.jpg?itok=6XnaYKS9)
On this page:
What's new | The FDA's role and strategic approach | Product development | Antimicrobial stewardship | Surveillance and monitoring | Regulatory science | FDA publications | Information for consumers | Press and statements | Events | Interagency collaboration | Contact the FDA
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, 148 pages), 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.
What's new
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February 25, 2022: FDA cleared the VITEK 2 AST-Yeast Fluconazole (≤0.5 - ≥64 µg/mL) (K213241), a miniaturized, abbreviated and automated version of the classic broth dilution method to determine the minimum inhibitory concentration of fluconazole, an antifungal agent with updated breakpoints for testing Candida albicans, Candida parapsilosis, and Candida tropicalis.
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February 15, 2022: FDA’s Center for Veterinary Medicine (CVM) released a request for public comments about antimicrobial use in companion animals (e.g., cats, dogs, horses) and the potential impact of this use on antimicrobial resistance in both animals and people. The Federal Register notice includes specific questions for commenters to consider. CVM intends to use the information collected to help develop strategies to further promote antimicrobial stewardship in companion animals. Comments are due by June 16, 2022.
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February 4, 2022: FDA cleared the VITEK 2 AST-Gram Positive Linezolid (≤0.5 - ≥8 µg/mL) (K212849), a miniaturized, abbreviated and automated version of the classic broth dilution method to determine the minimum inhibitory concentration of linezolid, an antibiotic with updated breakpoints for testing Staphylococcus species
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January 21, 2022: Beginning March 1, 2022, FDA’s Center for Veterinary Medicine will accept grant applications for FY 2022 to support innovative ways to provide education on antimicrobial stewardship practices in food-producing animals. Applications are due by May 2, 2022.
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December 15, 2021: Beginning February 1, 2022, FDA’s Center for Veterinary Medicine will accept applications for Fiscal Year (FY) 2022 to support research and the development of alternatives to antimicrobials for use in food-producing animals. Applications are due by April 1, 2022.
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.
- The FDA employs a variety of mechanisms, where appropriate, to help speed the development and availability of medical products for humans: Fast track designation, priority review, and breakthrough therapy designation.
- Under Generating Antibiotic Incentives Now (Report to Congress; PDF, 545 KB), or GAIN, the FDA is authorized to provide a five-year extension of exclusivity to incentivize the development of new Qualified infectious disease products (QIDPs) (PDF, 390 KB). A QIDP is defined as “an antibacterial or antifungal drug for human use intended to treat serious or life-threatening infections, including those caused by an antibacterial or antifungal resistant pathogen.” As of August 2018, the FDA has approved 15 new QIDPs for bacterial or fungal infections.
- Established by Congress under the 21st Century Cures Act, the Limited Population Pathway for Antibacterial and Antifungal Drugs, or LPAD pathway, is a new step to help advance development of antimicrobial drugs for limited populations of patients with unmet need.
- Experts from the FDA’s Center for Biologics Evaluation and Research provide advice to academic investigators and sponsors through the Initial Targeted Engagement for Regulatory Advice on CBER Products (INTERACT), which can help streamline product development and approval.
- The FDA is also in discussion with other agencies including the Centers for Medicare and Medicaid Services (CMS) to explore the means for reimbursement of certain new antibacterial drugs that meet critical patient and public health needs.
The FDA is working to advance the development of nontraditional antimicrobial products including:
- Bacteriophages (viruses that infect, replicate within, and ultimately destroy bacteria)
- Live biotherapeutic products (LBP) (biological products that 1) contain live organisms, such as bacteria; 2) are applicable to the prevention, treatment, or cure of a disease or condition of human beings; and 3) are not a vaccine)
- Also see from CBER: Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information (Guidance for Industry) (PDF, 174 KB)
- Microbiome therapies (e.g., fecal microbiota for transplantation (FMT))
- Also see from CBER: Regulatory Considerations for Fecal Microbiota Transplantation Products. Cell Host &Microbe 27:173-175, 2020; DOI 10.1016/j.chom.2020.01.018
- Immune-modulators
The FDA is also working to advance the development of vaccines for organisms contributing to AMR.
- Also see from CBER: General Principles for the Development of Vaccines to Protect Against Global Infectious Diseases (Guidance for Industry) (PDF, 58 KB)
FDA encourages the development of novel in vitro diagnostic (IVD) devices for detection of AMR associated with microbial pathogens.
When searching for AMR-related device approvals it is helpful to know the associated Product Code for the class of AMR-related devices.
- You can find these codes in the CDRH Product Classification database, by searching for the terms susceptibility, antimicrobial, or resistance in the “device” section.
- While not a complete list, examples of Product Codes associated with AMR-related device approvals include: JTN, JWY, LON, LTT, LRG, LTW, PEN, PAM, and POC.
- These Product Codes include phenotypic antimicrobial susceptibility test (AST) devices and devices that determine AMR by other means, such as genetic markers. (FDA maintains a list of cleared or approved Microbial Nucleic Acid Devices; please note that this list also includes other devices that do not detect genetic markers of resistance.)
- Knowing the Product Code also makes it easier to find specific AMR-related device approvals when searching the PMA, de novo, and 510(k) databases.
Recently cleared IVD devices, including Antimicrobial Susceptibility Test (AST) devices, include:
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February 25, 2022: FDA cleared the VITEK 2 AST-Yeast Fluconazole (≤0.5 - ≥64 µg/mL) (K213241), a miniaturized, abbreviated and automated version of the classic broth dilution method to determine the minimum inhibitory concentration of fluconazole, an antifungal agent with updated breakpoints for testing Candida albicans, Candida parapsilosis, and Candida tropicalis.
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February 4, 2022: FDA cleared the VITEK 2 AST-Gram Positive Linezolid (≤0.5 - ≥8 µg/mL) (K212849), a miniaturized, abbreviated and automated version of the classic broth dilution method to determine the minimum inhibitory concentration of linezolid, an antibiotic with updated breakpoints for testing Staphylococcus species
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December 20, 2021: FDA cleared the Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Cefiderocol in the Dilution Range of 0.03-64 µg/mL (K203741), a miniaturized version of the classic broth dilution method to determine the minimum inhibitory concentration of Cefiderocol with additional indicated species (Acinetobacter baumannii and Serratia marcescens) and using updated breakpoints for members of the Enterobacterales order.
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December 15, 2021: FDA cleared the Sensititre YeastOne Susceptibility System with Voriconazole in the Dilution Range of 0.008 - 8 μg/mL (K211539), a micro-version of the broth dilution susceptibility test performed in multi-well microtiter plates to determine the minimum inhibitory concentration of voriconazole, an antifungal agent with new breakpoints and indications for testing Candida species.
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November 12, 2021: FDA cleared the ETEST Fosfomycin (FO) (0.032-512 µg/mL) (K210757), a gradient diffusion assay to determine the minimum inhibitory concentration of Fosfomycin, an antibiotic used for the treatment of urinary tract infection.
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October 28, 2021: FDA cleared the APAS Independence with IC Chromogenic MRSA BD Analysis Module and the APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module (K200839), an in vitro diagnostic test system for the automated assessment of microbial colonies on chromogenic culture media to aid in screening for methicillin-resistant Staphylococcus aureus (MRSA).
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October 28, 2021: FDA cleared the VITEK 2 AST- Streptococcus Cefotaxime (≤0.125 - ≥8 µg/mL) (K210287), an abbreviated and automated version of a broth microdilution assay to determine the minimum inhibitory concentration of Cefotaxime with Streptococcus species.
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October 27, 2021: FDA cleared the Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20 (K210873), a disk diffusion assay for in vitro susceptibility testing of Lefamulin, a first-in-class antibiotic for the treatment of community-acquired bacterial pneumonia.
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October 20, 2021: FDA cleared the MTS Piperacillin-Tazobactam 0.016/4 - 256/4 µg/mL (K211672), a gradient diffusion assay to determine the minimum inhibitory concentration of Piperacillin-Tazobactam, a combination antibiotic that is used to treat various bacterial infections.
- September 30, 2021: FDA cleared the Acuitas AMR Gene Panel (K191288), a qualitative nucleic acid-based, highly multiplexed in vitro diagnostic test for the simultaneous detection and identification of 28 genetic determinants of resistance to 8 antibiotic groups (aminoglycosides, carbapenems, cephalosporins, fluoroquinolones, penicillins, sulfonamides, trimethoprim, vancomycin) among 19 organism species for a total of 117 unique organism/gene combinations being reported. The Acuitas AMR Gene Panel includes an extension of the device labeling (electronic user guide) that provides additional supporting information about performance characteristics and interpretation of genetic determinants associated with antimicrobial resistance for the Acuitas AMR Gene Panel.
- September 14, 2021: FDA cleared the VITEK 2 AST-Gram Positive Fosfomycin (≤8 - ≥256 µg/mL) (K202396), an abbreviated and automated version of a broth microdilution assay to determine the minimum inhibitory concentration of Fosfomycin, an antibiotic used for the treatment of urinary tract infection.
- July 30, 2021: FDA cleared the Thermo Scientific Oxoid Cefiderocol Disc (30ug) FDC30 (K203700), a disk diffusion assay for in vitro susceptibility testing of Cefiderocol, a newer antibiotic for the treatment of complicated urinary tract infection.
- July 23, 2021: FDA cleared the Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Autoread Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 ug/mL) (K202612), a miniaturized version of the classic broth dilution method that can provide both qualitative and quantitative susceptibility results from Haemophilus influenza, Streptococcus pneumoniae and Streptococcus species when tested with erythromycin or clindamycin. The Dtest detects for inducible clindamycin resistance in Streptococcus spp. resistant to erythromycin.
- July 9, 2021: FDA cleared the VITEK 2 AST-Gram Negative Meropenem (≤0.25 - ≥16 µg/mL) (K201675), an abbreviated and automated version of a broth microdilution assay to determine the minimum inhibitory concentration of Meropenem, an antibiotic for which FDA recently updated interpretive criteria.
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June 14, 2021: FDA cleared the VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 µg/mL) (K211136), an abbreviated and automated version of a broth microdilution assay to determine the minimum inhibitory concentration of Imipenem/Relebactam. A claim was added to the previously cleared device to include a new indicated species, Acinetobacter calcoaceticus-baumannii complex.
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May 27, 2021: FDA cleared the MicroScan MICroSTREP Plus Panels With Tetracycline (0.06-16 µg/mL) (K202423), an abbreviated version of a broth microdilution assay to determine the minimum inhibitory concentration of Tetracycline with aerobic streptococci. Performance data was updated to include reanalysis of MIC results for Streptococcus pneumoniae with tetracycline using currently recognized interpretive criteria.
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November 16, 2020: MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 μg/mL) (K202343), an abbreviated version of a broth microdilution assay to determine the minimum inhibitory concentration of Ceftazidime, a antibacterial used to treat lower respiratory tract infections, skin and skin-structure infections, bacterial septicemia, bone and joint infections, gynecologic infections, intra-abdominal infections and central nervous system infections
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September 28, 2020: VITEK 2 AST-Gram Negative Ceftazidime (≤0.5 - ≥32 µg/mL) (K193299) an abbreviated and automated version of a broth microdilution assay to determine the minimum inhibitory concentration of Ceftazidime, a antibacterial used to treat lower respiratory tract infections, skin and skin-structure infections, bacterial septicemia, bone and joint infections, gynecologic infections, intra-abdominal infections and central nervous system infections.
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September 15, 2020: Accelerate Pheno System, Accelerate PhenoTest BC Kit (K192665) a multiplexed in vitro diagnostic test utilizing both qualitative nucleic acid fluorescence in situ hybridization (FISH) identification and quantitative antimicrobial susceptibility methods directly from positive blood culture samples. Claims were added for antimicrobial susceptibility testing of Pseudomonas aeruginosa with ceftazidime, cefepime, meropenem, piperacillin/tazobactam, and aztreonam.
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June 29, 2020: Addition of Acinetobacter spp. for testing with the MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004 - 32 µg/mL) (K201423), an abbreviated version of a broth microdilution assay to determine the minimum inhibitory concentration of Meropenem, an antibiotic for which FDA recently updated the susceptibility test interpretive criteria on the STIC website to include interpretive criteria when testing this organism group.
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May 7, 2020: ETEST Plazomicin (0.016 - 256 µg/mL) (K200512) a gradient diffusion assay to determine the minimum inhibitory concentration of Plazomicin, an antibiotic for the treatment of complicated urinary tract infection
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April 28, 2020: VITEK 2 AST-Gram Positive Delafloxacin (≤0.015 - ≥1 µg/mL) (K200590) an abbreviated and automated version of a broth microdilution assay to determine the minimum inhibitory concentration of Delafloxacin, an antibiotic approved for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI)
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April 6, 2020: MTS Lefamulin 0.016 - 256 µg/mL (K200308) a gradient diffusion assay to determine the minimum inhibitory concentration of Lefamulin, a first-in-class antibiotic for the treatment of community-acquired bacterial pneumonia.
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March 20, 2020: MTS Omadacycline 0.002 - 32 µg/mL (K200180) a gradient diffusion assay to determine the minimum inhibitory concentration of Omadacycline, a new antibiotic for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).
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March 18, 2020: MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8 µg/mL) (K193536) an abbreviated version of a broth microdilution assay to determine the minimum inhibitory concentration of Ciprofloxacin, an antibiotic for which FDA recently recognized revised interpretive criteria and published those on the FDA STIC webpage.
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March 18, 2020: BioFire Blood Culture Identification 2 (BCID2) Panel (K193519) a multiplexed nucleic acid-based test for the detection and identification of multiple bacterial and yeast nucleic acids and select genetic determinants associated with antimicrobial resistance direct from positive blood culture samples.
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March 13, 2020: VITEK 2 AST-Gram Negative Imipenem/Relebactam (≤0.25/4 - ≥16/4 µg/mL) (K193572) abbreviated and automated version of a broth microdilution assay to determine the minimum inhibitory concentration of Imipenem/Relebactam, an antibiotic approved eight months ago for the treatment of complicated urinary tract infections and complicated intra-abdominal infections.
- March 12, 2020: Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 µg/mL (K193538) an abbreviated and automated version of a broth microdilution assay to determine the minimum inhibitory concentration Cefiderocol, an antibiotic approved four months ago for the treatment of complicated urinary tract infections.
- March 3, 2020: MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008 - 16 µg/mL) (K193358) an abbreviated version of a broth microdilution assay to determine the minimum inhibitory concentration of Levofloxacin, an antibiotic for which FDA recently recognized revised interpretive criteria and published those on the FDA STIC webpage.
- January 8, 2020: Sensititre 20-24 hour Haemophilus influenzae/Streptococcus Pneumoniae MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008 – 16 µg/mL (K193024) a broth-microdilution assay that was cleared shortly after new drug approval for Lefamulin, a first-in-class antibiotic for the treatment of community-acquired bacterial pneumonia.
- January 23, 2020: HardyDisk AST Cefiderocol 30µg (FDC30) (K193504) a disk diffusion assay that was the first AST device for Cefiderocol, an antibiotic for the treatment of complicated urinary tract infection. This device was cleared just eight weeks after new drug approval.
- December 20, 2019: FDA recently cleared the Unyvero LRT BAL Application (K191967), a multiplex molecular test for the detection and identification of nucleic acid sequences from 20 bacterial/fungal pathogens and 10 antibiotic resistance markers to aid in the diagnosis of pneumonia. It is the first multiplexed pneumonia panel that identifies Pneumocystis jirovecii, a leading cause of pneumonia in immunocompromised patients.
- December 5, 2019: FDA authorizes marketing of diagnostic test that uses novel technology to detect MRSA bacteria - FDA authorized marketing of a new diagnostic test based on bacterial viability and novel technology to detect Methicillin-resistant Staphylococcus aureus (MRSA) bacterial colonization, a widespread cause of hospital-acquired infections. The cobas vivoDx MRSA diagnostic test may allow health care professionals to evaluate patients for colonization with MRSA bacteria more quickly than traditional culture-based techniques when such testing is needed.
- November 26, 2019: FDA cleared the AST device bioMerieux ETEST Delafloxacin (DFX) 0.002-32 μg/mL (K192738) a gradient diffusion assay for testing Delafloxacin
- November 14, 2019: FDA cleared the AST device MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL) (K192355) a broth-microdilution assay for testing Meropenem.
- November 6, 2019: FDA recently cleared AST devices for testing newly approved antimicrobial agents:
- HardyDisk AST Lefamulin 20µg (LMU20) (K192326) a disk diffusion assay for testing Lefamulin (September 19, 2019)
- ETEST Eravacycline (ERV) (0.002 – 32 Μg/ML) (K192050) a gradient diffusion assay for testing Eravacycline (September 29, 2019)
- Sensititre 18-24 Hour MIC Or Breakpoint Susceptibility System With Imipenem-Relebactam In The Dilution Range Of 0.03/4-256/4 Ug/ML (K192250) a broth-microdilution assay for testing Imipenem-Relebactam. (October 16, 2019) This device was evaluated under the auspices of the coordinated development guidance (issued on February 1, 2019) which aims at achieving timely availability of AST devices.
- AST device Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008 – 16 µg/mL (K192729) a broth-microdilution assay that was cleared just 80 days after new drug approval for Lefamulin, a first-in-class antibiotic for the treatment of community-acquired bacterial pneumonia. (November 6, 2019)
- October 31, 2019: FDA cleared the AST device MTS Ampicillin-Sulbactam 0.016/0.008 – 256/128 µg/mL (K192345) a gradient diffusion assay for testing Ampicillin-Sulbactam.
- October 2, 2019: FDA cleared NG Test CARBA 5 (K191889), the first rapid lateral flow immunochromatographic assay that detects and differentiates between five common types of carbapenemase enzymes (KPC, OXA, NDM, VIM, IMP). The assay tests pure colonies after growth on solid media, with results obtained in 15 minutes. The test is intended as an aid infection control.
- September 25, 2019: FDA cleared ARIES MRSA assay (K191742), another nucleic acid amplification test (NAAT) for MRSA detection from nasal swabs. This and similar assays are used as an aid in the prevention and control of MRSA infections in healthcare settings.
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.
On the veterinary side, the FDA’s Center for Veterinary Medicine (CVM) is responsible for:
- Ensuring that animal drugs are safe and effective for their approved conditions of use, and
- Playing an active role in coordinating the development and implementation of regulations and policies pertaining to antimicrobial drugs intended for use in animals, including food-producing animals.
CVM’s activities to advance antimicrobial stewardship are further detailed in CVM’s plan, Supporting Antimicrobial Stewardship in Veterinary Settings: Goals for Fiscal Years 2019-2023 (PDF, 282 KB). Also see: FDA-TRACK: Progress on FDA’s Support of Antimicrobial Stewardship in Veterinary Settings
On the human healthcare side, the FDA supports policies and regulations designed to preserve the effectiveness of antimicrobials for human use. This includes:
- Working to ensure the labeling of antimicrobial drugs intended for use in humans contain required statements regarding appropriate use
- Providing recommendations on scientifically sound clinical trial designs to evaluate human drugs to help inform appropriate use and stewardship efforts
- Maintaining the FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria webpage
- Working with diagnostic manufacturers and academia on developing biomarkers to rapidly identify whether a patient’s symptoms are due to a bacterial infection, or when antibiotics can be stopped during treatment
- Promoting flexible regulatory approaches to rapid identification of bacterial pathogens, thereby allowing targeted antibiotic treatment and reducing broad-spectrum antibiotic use
Also see from CDER: Combating Antibiotic Resistance
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.
- A partnership between the FDA, the CDC, and the U.S. Department of Agriculture (USDA), the National Antimicrobial Resistance Monitoring System (NARMS) tracks and provides information on antimicrobial resistance in foodborne bacteria in humans, retail meats, and food-producing animals.
- NARMS Strategic Plan 2021-2025 (PDF, 127 KB) (August 19, 2020)
- 2016-2017 NARMS Integrated Summary
- The FDA is funding cooperative agreements to support collection of data on antimicrobial use in U.S. animal agriculture. The FDA has also provided input to USDA’s Center for Epidemiology and Animal Health on surveys to collect information on antimicrobial use in animal agriculture.
- Antimicrobial drug sponsors are required to report annually to the FDA the amounts of antimicrobial drugs sold or distributed for use in food-producing species during the prior year. The FDA’s Center for Veterinary Medicine publishes an annual report summarizing the data contained in those submissions.
- Most recent annual report: 2018 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals
- The FDA is leveraging in vitro diagnostic device data standards to enhance real-time infectious disease/AMR surveillance.
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 2021: 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 FARS@fda.hhs.gov with questions about this initiative.
- CDC-FDA Antimicrobial Resistance Isolate Bank (AR Isolate Bank)
- Database for Reference Grade Microbial Sequences (FDA-ARGOS)
- FDA Launches Resistome Tracker, an Interactive Research and Data Visualization Tool for Antibiotic Resistance Genes
- National Database of Antibiotic Resistant Organisms (NDARO), from NIH
- NARMS Now: Human Data
- GenomeTrakr Network
Community stakeholders: We need your samples
As part of our effort to address the global health challenge of AMR, FDA supports the development of next-generation sequencing (NGS)-based diagnostics to help healthcare providers identify and treat the right pathogen. To help build NGS infrastructure, our FDA-ARGOS database makes publicly available quality-controlled microbial reference genomes for diagnostic use. The FDA team is looking for unique, hard-to-source microbes like biothreat organisms, emerging pathogens, and AMR-related pathogens to help improve the database. We encourage the community to share microbe samples.
Image: A lab worker in the CDC-FDA AR Isolate Bank (Credit: CDC)
The Center for Drug Evaluation and Research
- CDER's Office of Antimicrobial Products research activities include facilitating the development of new antibacterial drugs to treat patients and advancing the science of clinical trial design.
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Exploiting Real-World Data to Optimize the Use of Antibiotics - Through the National Action Plan for Combating Antibiotic-Resistant Bacteria (CARB) (PDF, 370KB - research summary published Nov. 2021), FDA's Center for Drug Evaluation and Research (CDER) has supported research at Johns Hopkins University School of Medicine to help us use the data in electronic health records to better understand the association between varying durations of antibiotic therapy and patient outcomes. These two research studies demonstrated the feasibility and advantages of a novel automated approach for extracting patient-level data from electronic health records to capture treatment outcomes in diverse real-world health care settings. The results provide valuable evidence to inform best practices related to the duration of antibiotic treatment in diverse bacterial infections, optimizing patient outcomes while reducing the risk for antimicrobial resistance.
The Center for Biologics and Evaluation and Research
- Research enabling development of new vaccines against tuberculosis:
- Research to facilitate development of vaccines against Staphylococcus aureus (e.g. MRSA):
The National Center for Toxicological Research’s Microbiology Division
- January 21, 2022: Beginning March 1, 2022, FDA’s Center for Veterinary Medicine will accept grant applications for FY 2022 to support innovative ways to provide education on antimicrobial stewardship practices in food-producing animals. Applications are due by May 2, 2022.
- December 15, 2021: Beginning February 1, 2022, FDA’s Center for Veterinary Medicine will accept applications for Fiscal Year (FY) 2022 to support research and the development of alternatives to antimicrobials for use in food-producing animals. Applications are due by April 1, 2022.
- November 22, 2021: FDA is accepting proposals focused on updating susceptibility test interpretive criteria (breakpoints). Specifically, research proposals focused on evaluating microbiologic, pharmacokinetic/pharmacodynamic, and clinical data that could be utilized by standards development organizations and the FDA to update breakpoints (including urine-specific breakpoints) will be prioritized. Proposals should be submitted to the Broad Agency Announcement (FDABAA-22-00123; priority area 2.4.4). Information on submitting the quad chart and white paper can be found on page 33. Quad charts and white papers are due by 5:00 p.m. ET, January 21, 2022. Additional information to apply to this open announcement:
- FY22 Request for Proposals for Breakpoints (PDF, 153 KB)
- FY22 Request for Proposals for uUTI Breakpoints Models (PDF, 133 KB)
- December 2, 2020: FDA is accepting proposals focused on research assessing the impact of extended-infusion of beta-lactam antibacterial drugs on development of beta-lactam resistance and patient outcomes. Specifically, research proposals focused on evaluating the impact of dosing strategies for beta-lactam antibacterial drugs for serious infections caused by gram-negative pathogens on development of beta-lactam resistance and patient outcomes will be prioritized. Proposals should be submitted to the Broad Agency Announcement (FDABAA-21-00123). Quad charts and white papers are due by January 28, 2021. Also see: Additional information to apply to this open announcement (PDF, 129 KB)
- November 24, 2020: FDA is accepting proposals focused on research that may support updating susceptibility test interpretive criteria (breakpoints). Specifically, research proposals focused on evaluating microbiologic and pharmacokinetic data that could be utilized by standards development organizations and the FDA to update breakpoints will be prioritized. Proposals should be submitted to the Broad Agency Announcement (FDABAA-21-00123). Quad charts and white papers are due by January 28, 2021. Also see: Additional information to apply to this open announcement (PDF, 99 KB)
- Beginning on March 2, 2020, FDA’s Center for Veterinary Medicine will accept applications for Fiscal Year (FY) 2020 to collect antimicrobial use information from dogs and cats. The data obtained will support efforts to assess potential associations between antimicrobial use practices and antimicrobial resistance. Applications are due by May 15, 2020.
- From March 2 to April 1, 2020, the FDA’s Center for Veterinary Medicine (CVM) will accept research applications for the FY 2020 grant program, which could fund up to $2 million to generate evidence to support the establishment of more appropriately targeted and defined durations of use for one or more of the new animal drug applications identified on the list of affected approved animal drug applications.
- February 10, 2020: FDA announces a new Fiscal Year 2020 funding opportunity and Request for Applications to support the collection of data on antimicrobial use in dogs and cats. FDA's Center for Veterinary Medicine (CVM) has funded several ongoing studies to collect use data in food-producing animals and believes it is also important to collect data about the use of antimicrobial drugs in dogs and cats and how these use practices might contribute to the development of antimicrobial resistant bacteria.
- The FDA Office of Infectious Diseases is accepting proposals focused on updating susceptibility test interpretive criteria (breakpoints). Specifically, research proposals focused on evaluating microbiologic and pharmacokinetic data that could be utilized by standards development organizations and the FDA to update breakpoints will be prioritized. Proposals should be submitted to the FDA Broad Agency Announcement, priority area 2.4.4. Quad charts and white papers are due by February 28, 2020. Additional information about applying (Word doc, 25 KB) (December 20, 2019)
- FDA Announces Funding Opportunity to Help Define Durations of Use for Certain Medically Important Antimicrobial Drugs for Food Animals - FDA announced a funding opportunity and Request for Applications (RFA) for studies that can help target and define durations of use for certain medically important antimicrobial drugs approved for use in the feed of food-producing animals. The agency also posted a list of the affected products. FDA's Center for Veterinary Medicine (CVM) will accept research applications for the fiscal year 2019 program from April 1 to June 3, 2019. Update: FDA Awards $500,000 to Fund Studies to Help Define Duration of Use for Certain Medically Important Antimicrobial Drugs for Food Animals (September 27, 2019)
- Development of New Antibacterial Drugs Active Against Multi-Drug Resistant Bacteria - CDER's Office of Antimicrobial Products issued a Request for Information (RFI) on September 11, 2018, 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.
- FDA Broad Agency Announcement (FDABAA-18-00123N) – The FDA is seeking research and development to support regulatory science and innovation, including projects supporting the agency's AMR-related goals. This funding opportunity is open until further notice. Also see: Regulatory Science Extramural Research and Development Projects
- CARB-X - CARB-X is a non-profit public-private partnership dedicated to accelerating antibacterial research to tackle the global rising threat of drug-resistant bacteria. CARB-X welcomes applications from around the world for funding and support for the early development of antibiotics, diagnostics, vaccines, devices, and other products to combat the most serious drug-resistant bacteria. Visit the CARB-X website for information on application deadlines.
- Antimicrobial Resistance Diagnostic Challenge - A $20 million federal prize competition seeking innovative, rapid point-of-care laboratory diagnostic tests to combat the development and spread of drug-resistant bacteria. Visit the Challenge website for information on application deadlines. Update: Antimicrobial Resistance Diagnostic Challenge names five finalists (December 3, 2018, from NIH)
FDA publications
Guidance documents, compliance policy guides, and other FDA publications represent the FDA's current thinking on a topic. Documents related to antimicrobial resistance in humans and animals include guidances on developing products for treatment, prevention, and diagnosis of bacterial infections. You can also find information for the animal and veterinary industry on collection of sales and distribution of antimicrobial products, and veterinary feed directives.
You can search the entire database of FDA guidance documents by keyword, or visit the industry pages below for more information.
For information about FDA-recognized antimicrobial susceptibility test interpretive criteria, visit http://www.fda.gov/STIC, and the corresponding Notice of Updates.
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November 9, 2021: Exploiting Real-World Data to Optimize the Use of Antibiotics
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October 2021: FDA CDER Office of Infectious Diseases CARB Research Overview Fiscal Years 2016-2021 (PDF, 370 KB)
- August 28, 2020: FDA updated omadacycline disk breakpoints for Streptococcus pneumoniae for community acquired bacterial pneumonia and updated susceptibility test interpretive criteria for daptomycin (rationale).
- August 5, 2020: FDA issued a final guidance, Limited Population Pathway for Antibacterial and Antifungal Drugs.
- June 29, 2020: FDA issued a draft guidance, Development of Anti-Infective Drug Products for the Pediatric Population. Submit comments by August 29, 2020.
- June 24, 2020: FDA issued two final guidances, Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment, and Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment.
- December 23, 2019: FDA has recognized the standard for Acinetobacter spp. for meropenem.
- September 5, 2019: FDA has added pretomanid and lefamulin to the antibacterial susceptibility test interpretive criteria web page. FDA identified susceptibility test interpretive criteria for lefamulin, which can be found on the antibacterial susceptibility test interpretive criteria web page. There are no identified susceptibility test interpretive criteria for pretomanid at this time.
- July 26, 2019: FDA has added imipenem-cilastatin-relebactam to the antibacterial susceptibility test interpretive criteria web page.
- July 18, 2019: FDA finalized a guidance document, Submitting Next Generation Sequencing Data to the Division of Antiviral Products Guidance for Industry Technical Specifications Document. The purpose of this technical specifications document is to provide the current thinking of FDA’s Division of Antiviral Products in regard to the submission of next generation nucleotide sequence analysis procedures and data in support of resistance assessments for the development of antiviral drug products. Providing accurate resistance information is imperative for protecting public health to prevent the emergence of novel resistant and cross-resistant viral variants that have the potential to infect others and cause major outbreaks of disease that cannot be controlled by approved drug products.
- February 2, 2018: Report to Congress on Generating Antibiotic Incentives Now (GAIN) (PDF, 545KB)
- 510(k) Premarket Notification and de novo databases – provide information on all in vitro diagnostic devices cleared or granted since November 2003, including devices that detect antibiotic resistance markers, phenotypic antimicrobial susceptibility devices, and biomarkers used to aid in patient management
- Part of FDA's strategic approach for combatting antimicrobial resistance involves providing guidance that aims to facilitate the availability of antimicrobial susceptibility tests in a timely manner once a new antibacterial drug is approved. On January 17, 2019, FDA published a new guidance for industry, Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices (PDF, 438 KB). The goal of this guidance is to minimize time between the approval of new antimicrobial drugs and clearance of antimicrobial susceptibility tests used to determine the potential effectiveness of those drugs; and provide recommendations to the medical device and drug industries on how to work together to facilitate timely clearance of antimicrobial susceptibility test devices by the FDA. FDA will discuss this final guidance at a webinar scheduled for February 12, 2019. (Federal Register notice)
- December 14, 2021: FDA’s Center for Veterinary Medicine published the 2020 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals. This year’s report shows that domestic sales and distribution of medically important antimicrobial drugs approved for use in food-producing animals decreased by three percent between 2019 and 2020. That is a 38 percent decrease since 2015, which was the peak year of sales.
- June 10, 2021: FDA finalized Guidance for Industry #263 to outline the process for animal drug sponsors to voluntarily change the approved marketing status of certain medically important antimicrobial drugs from over-the-counter (OTC) to prescription (Rx). Once this transition is complete, animal drugs containing medically important antimicrobials can only be administered under veterinary oversight and only for therapeutic uses.
- April 9, 2021: FDA has heard from several stakeholders about technical difficulties submitting comments to the Federal eRulemaking portal about Concept Paper: Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs (PDF, 274 KB) before the comment period closed on March 16, 2021. In response to these difficulties, FDA is briefly reopening the comment period until April 22, 2021, to allow these stakeholders the opportunity to submit comments. Previously submitted comments do not need to be resubmitted.
- On January 8, 2021, FDA's Center for Veterinary Medicine published a concept paper to obtain early input from the public on a potential framework for how animal drug sponsors could voluntarily make changes to the approved conditions of use for certain medically important antimicrobial drugs approved for use in or on the feed of food-producing animals to establish a defined duration of use for those indications that currently lack a defined duration of use. FDA-CVM also published a Federal Register notice that invites the public to comment on specific questions regarding the concept paper until April 12, 2021.
- On December 15, 2020, FDA's Center for Veterinary Medicine published the 2019 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals. The report shows that domestic sales and distribution of medically important antimicrobials approved for use in food producing animals increased by three percent between 2018 and 2019. The trend over time indicates that ongoing efforts to support antimicrobial impact are having an impact: sales and distribution are down 25% since 2010 and down 36% since 2015, which was the peak year of sales.
- On December 11, 2020, FDA, in cooperation with the U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Department of Agriculture’s Food Safety and Inspection Service (USDA-FSIS), its partners in the National Antimicrobial Resistance Monitoring System (NARMS), is releasing the 2018 NARMS Integrated Summary and NARMS Now: Integrated Data featuring predictive resistance functionality from genomic data. To learn more and to access the 2018 NARMS Integrated Summary and NARMS Now data, visit FDA Releases 2018 NARMS Integrated Summary and NARMS Now: Integrated Data Featuring Genomic Data and Predicted Resistance.
- On October 9, 2020, FDA released a concept paper, Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs (PDF, 273 KB), for public comment and announced a virtual public meeting on November 16, 2020. On November 25, 2020, in response to requests to extend the comment period, FDA plans to provide an additional 60 days for the public to submit comments on this concept paper. The new deadline to submit comments is March 16, 2021.
- National Antimicrobial Resistance Monitoring System (NARMS) Strategic Plan 2021-2025 (PDF, 127 KB) (August 19, 2020)
- 2018 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals (PDF, 584 KB) (December 10, 2019)
- 2016-2017 NARMS Integrated Summary (November 2019) - an interactive version is also available
- FDA issues draft guidance to voluntarily bring remaining approved over-the-counter medically important antimicrobial drugs for animals under veterinary oversight (September 23, 2019) - FDA released the draft guidance for industry #263 Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter, to help explain the recommended process for voluntarily bringing the limited number of remaining approved animal drugs containing antimicrobials of human medical importance (i.e., medically important) under the oversight of licensed veterinarians by changing the approved marketing status from over-the-counter to prescription.
- Supporting Antimicrobial Stewardship in Veterinary Settings: Goals for Fiscal Years 2019-2023 (PDF, 282 KB)
- FDA-TRACK: Progress on FDA’s Support of Antimicrobial Stewardship in Veterinary Settings
- Antimicrobial Resistance Guidances – information for animal and veterinary industry
- Veterinary Feed Directive
- FDA’s Proposed Method for Adjusting Data on Antimicrobials Sold or Distributed for Use in Food-Producing Animals Using a Biomass Denominator (PDF, 174 KB)
Information for consumers
- Educational Resources: Antibiotics and Antibiotic Resistance – includes printable brochures and posters
- Animation of Antimicrobial Resistance (video, 9 minutes – text version also available)
- Antimicrobial Resistant Bacteria in Animals and Food – animal health literacy FAQs
- Judicious Use of Antimicrobials
- Questions and Answers: Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals
- The CDC campaign, “Be Antibiotics Aware,” offers web pages, brochures, fact sheets, and other information to help the public learn about preventing antibiotic-resistant infections
- Antibiotic/Antimicrobial Resistance - information from the CDC
- National Strategy for Combating Antibiotic Resistant Bacteria (CARB) (PDF, 481 KB)
- Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB) - provides advice, information, and recommendations to the HHS Secretary regarding programs and policies intended to support and evaluate the implementation of U.S. government activities related to combating antibiotic-resistant bacteria
- The AMR Challenge - The U.S. government’s AMR Challenge is a year-long effort to accelerate the fight against antimicrobial resistance across the globe. Organizations can make commitments beginning September 25, 2018 until September 2019. Also see: U.S. Challenges World to Intensify Global Fight against Antibiotic Resistance (September 25, 2018)
Press and statements
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February 15, 2022: FDA’s Center for Veterinary Medicine (CVM) released a request for public comments about antimicrobial use in companion animals (e.g., cats, dogs, horses) and the potential impact of this use on antimicrobial resistance in both animals and people. The Federal Register notice includes specific questions for commenters to consider. CVM intends to use the information collected to help develop strategies to further promote antimicrobial stewardship in companion animals. Comments are due by June 16, 2022.
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November 23, 2021: FDA Approves First Treatment for Common Type of Post-Transplant Infection that is Resistant to Other Drugs - FDA approved Livtencity (maribavir) as the first drug for treating adults and pediatric patients (12 years of age and older and weighing at least 35 kilograms) with post-transplant cytomegalovirus (CMV) infection/disease that does not respond (with or without genetic mutations that cause resistance) to available antiviral treatment for CMV. Livtencity works by preventing the activity of human cytomegalovirus enzyme pUL97, thus blocking virus replication.
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November 18, 2021: FDA approved an abbreviated new drug application for vancomycin hydrochloride for injection, indicated to treat serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. The side effects of Vancomycin Hydrochloride for injection include diarrhea, hypotension (low blood pressure), acute kidney injury, and ototoxicity (damage to the ear).
- March 12, 2021: FDA approved Kimyrsa (PDF, 593 KB), for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of Gram-positive microorganisms, including Methicillin-resistant Staphylococcus aureus (MRSA). Kimyrsa is administered as a single dose over the course of one hour. Orbactiv, another oritavancin product is also approved for the treatment of ABSSSI and is administered over the course of three hours. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Kimyrsa and other antibacterial drugs, Kimyrsa should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
- January 8, 2021: FDA Seeks Public Comment on Potential Approach for Defining Durations of Use for Certain Medically Important Antimicrobial Drugs for Food Animals
- October 6, 2020: FDA Insight podcast: Anti-Microbial Resistance - Dr. Shah welcomes Dr. Steve Solomon, Director of FDA's Center for Veterinary Medicine (CVM), to discuss the work CVM is doing in combating AMR
- September 25, 2020: FDA approves Treatment for Patients 18 Years of Age or Older with Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia (PDF, 491 KB)
- August 19, 2020: FDA Releases National Antimicrobial Resistance Monitoring System (NARMS) Strategic Plan, Announces October 2020 NARMS Virtual Public Meeting
- June 4, 2020: FDA Approves Antibiotic to Treat Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia
- December 10, 2019: FDA Releases Annual Summary Report on Antimicrobials Sold or Distributed in 2018 for Use in Food-Producing Animals - FDA released the 2018 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals (PDF, 584 KB), which showed that domestic sales and distribution of medically important antimicrobials for use in food-producing animals increased nine percent between 2017 and 2018. Despite this increase, 2018 is the second-lowest year on record and the overall trend continues to indicate that ongoing efforts to support antimicrobial stewardship are having an impact: sales in 2018 are down 21 percent since 2009, the first year of reporting, and down 38 percent since 2015, the peak year of sales and distribution.
- December 5, 2019: FDA authorizes marketing of diagnostic test that uses novel technology to detect MRSA bacteria - FDA authorized marketing of a new diagnostic test based on bacterial viability and novel technology to detect Methicillin-resistant Staphylococcus aureus (MRSA) bacterial colonization, a widespread cause of hospital-acquired infections. The cobas vivoDx MRSA diagnostic test may allow health care professionals to evaluate patients for colonization with MRSA bacteria more quickly than traditional culture-based techniques when such testing is needed.
- November 22, 2019: FDA, in cooperation with the Centers for Disease Control and Prevention (CDC) and the U.S. Department of Agriculture’s Food Safety and Inspection Service (USDA-FSIS), its partners in the National Antimicrobial Resistance Monitoring System (NARMS), released the 2016-2017 NARMS Integrated Summary. The new streamlined format will replace the annual NARMS Integrated Reports and enable NARMS partners to issue more timely public updates in the future. An interactive version is also available.
- November 14, 2019: FDA approves new antibacterial drug to treat complicated urinary tract infections as part of ongoing efforts to address antimicrobial resistance - FDA approved Fetroja (cefiderocol), an antibacterial drug for treatment of patients 18 years of age or older with complicated urinary tract infections (cUTI), including kidney infections caused by susceptible Gram-negative microorganisms, who have limited or no alternative treatment options.
- November 5, 2019: FDA authorizes marketing of first next-generation sequencing test for detecting HIV-1 drug resistance mutations - FDA authorized marketing of a test to detect human immunodeficiency virus (HIV) Type-1 drug resistance mutations using next-generation sequencing (NGS) technology. The Sentosa SQ HIV-1 Genotyping Assay is the first HIV drug resistance assay that uses NGS technology that the FDA has authorized for marketing in the U.S.
- October 21, 2019: FDA announced the availability of performance measures that track the progress of the Center of Veterinary Medicine’s (CVM) Five-Year Plan for Supporting Antimicrobial Stewardship in Veterinary Settings (PDF, 282 KB). This information is part of FDA-TRACK, a tool that promotes transparency and monitors certain FDA programs through performance measures and projects.
- September 23, 2019: FDA issues draft guidance to voluntarily bring remaining approved over-the-counter medically important antimicrobial drugs for animals under veterinary oversight - FDA released the draft guidance for industry #263 Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter, to help explain the recommended process for voluntarily bringing the limited number of remaining approved animal drugs containing antimicrobials of human medical importance (i.e., medically important) under the oversight of licensed veterinarians by changing the approved marketing status from over-the-counter to prescription.
- August 19, 2019: FDA approves new antibiotic to treat community-acquired bacterial pneumonia - FDA today approved Xenleta (lefamulin) to treat adults with community-acquired bacterial pneumonia. “For managing this serious disease, it is important for physicians and patients to have treatment options. This approval reinforces our ongoing commitment to address treatment of infectious diseases by facilitating the development of new antibiotics,” said Ed Cox, M.D., M.P.H., director of FDA’s Office of Antimicrobial Products. Also see: Drug Trials Snapshots: XENLETA (September 5, 2019)
- August 14, 2019: FDA approves new drug for treatment-resistant forms of tuberculosis that affects the lungs - FDA approved Pretomanid Tablets in combination with bedaquiline and linezolid for the treatment of a specific type of highly treatment-resistant tuberculosis (TB) of the lungs. Pretomanid is the second drug to be approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs, or LPAD pathway, established by Congress under the 21st Century Cures Act to advance development and approval of antibacterial and antifungal drugs to treat serious or life-threatening infections in a limited population of patients with unmet need. Also see: Drug Trials Snapshots: PRETOMANID (August 27, 2019)
- July 17, 2019: FDA approves new treatment for complicated urinary tract and complicated intra-abdominal infections - FDA has approved Recarbrio (imipenem, cilastatin and relebactam), an antibacterial drug product to treat adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI). It is important that the use of Recarbrio be reserved for situations when there are limited or no alternative antibacterial drugs for treating a patient’s infection. Also see: Drug Trial Snapshot: RECARBRIO (August 2, 2019)
- June 13, 2019: FDA In Brief: FDA warns about potential risk of serious infections caused by multi-drug resistant organisms related to the investigational use of Fecal Microbiota for Transplantation - FDA issued a safety communication regarding the use of Fecal Microbiota for Transplantation (FMT) and the risk of serious or life-threatening infections due to transmission of multi-drug resistant organisms (MDROs), as well as protections FDA has determined are needed for patients receiving investigational FMT. Also see: Information Pertaining to Additional Safety Protections Regarding Use of Fecal Microbiota for Transplantation – Screening and Testing of Stool Donors for Multi-drug Resistant Organisms (June 18, 2019)
- June 3, 2019: FDA approves new treatment for hospital-acquired and ventilator-associated bacterial pneumonia - FDA approved a new indication for the previously FDA-approved drug, Zerbaxa (ceftolozane and tazobactam) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years and older. The FDA initially approved Zerbaxa in 2014 to treat complicated intra-abdominal infections and for complicated urinary tract infections.
- January 23, 2019: FDA permitted marketing of a new test to aid in the diagnosis of a sexually-transmitted infection (STI) called Mycoplasma genitalium (M. gen.). This is the first test authorized by the FDA to test for the M. gen. bacterium, which is associated with inflammation of the urethra (non-gonococcal urethritis) in men and inflammation of the cervix (cervicitis) and infection of the reproductive organs (pelvic inflammatory disease) in women. Having accurate and reliable tests to identify the specific bacteria that’s causing an infection can assist doctors in choosing the right treatment for the right infection, which can reduce overuse of antibiotics and help in the fight against antimicrobial resistance.
- January 17, 2019: FDA in Brief: FDA takes new steps to advance development of antimicrobial susceptibility test devices that help identify appropriate drug treatments for infections and reduce overuse of antibiotics
- December 18, 2018: Statement from FDA Commissioner Scott Gottlieb, M.D. on the FDA’s 2017 report on declining sales/distribution of antimicrobial drugs for food animals, a reflection of improved antimicrobial stewardship
- October 2, 2018: FDA approved, NUZYRA, a new drug for treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI). To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZYRA and other antibacterial drugs, NUZYRA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. FDA granted Qualified Infectious Disease Product (QIDP) and Fast Track designations to NUZYRA. For more information, see the product label (PDF, 2.6 MB), and Drug Trials Snapshot (posted October 31, 2018).
- September 28, 2018: FDA approves a new antibacterial drug to treat a serious lung disease using a novel pathway to spur innovation - First drug granted approval under FDA’s Limited Population Pathway for Antibacterial and Antifungal Drugs, instituted to spur development of antibiotics for unmet medical needs
- September 14, 2018: Remarks from FDA Commissioner Scott Gottlieb, M.D., on FDA’s strategic approach for combating antibiotic resistance at an event 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)
- July 31, 2018: Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s new efforts to advance antimicrobial stewardship in veterinary settings
- 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
Events
The following is a list of select recent and upcoming AMR-related events involving the FDA.
- October 7, 2021: The Antimicrobial Drugs Advisory Committee will meet via webcast. The committee will discuss new drug application (NDA) 215596, for maribavir oral tablets, submitted by Takeda Pharmaceuticals USA, Inc., for the treatment of adults with post-transplant cytomegalovirus infection and/or disease, including infections resistant and/or refractory to ganciclovir, valganciclovir, cidofovir, or foscarnet. (Federal Register notice)
- August 30 - September 1, 2021: Science and Regulation of Bacteriophage Therapy workshop (virtual) - FDA's Center for Biologics Evaluation and Research, and the National Institutes of Health, National Institute of Allergy and Infectious Diseases (NIH/NIAID) are hosting a public workshop to exchange information with the medical and scientific community about the regulatory and scientific issues associated with bacteriophage therapy.
- April 23, 2021: Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea (virtual workshop), hosted by FDA, NIAID, and CDC to discuss the nonclinical and clinical pharmacology data and clinical trial design considerations regarding developing antimicrobial drugs for the treatment of gonorrhea.
- November 16, 2020: FDA Public Meeting on Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial Animal Drugs - To obtain early public input on a potential revised process and criteria for ranking antimicrobial drugs based on their importance in human medicine. The Agency is seeking public input on a concept paper (PDF, 273 KB) which includes a potential revised process for ranking antimicrobials according to their relative importance in human medicine, the potential criteria for their ranking, and the resulting ranked list of antimicrobial drugs.
- November 6, 2020: Office of New Drug (OND) Research: Seeking Collaborators; Funding Opportunities Available - webinar, 1:00 - 2:30 p.m. ET - Includes an overview of OND’s Combatting Antibiotic-Resistant Bacteria (CARB) and 21st Century Cures Drug Development Tools Grant programs
- October 13-14, 2020: Virtual Public Meeting of the National Antimicrobial Resistance Monitoring System
- August 4, 2020: Development Considerations of Antifungal Drugs to Address Unmet Medical Need (virtual).
- August 5, 2020: Developing Antifungal Drugs for the Treatment of Coccidioidomycosis (Valley Fever) Infection (virtual)
- March 5, 2020: Advancing Animal Models for Antibacterial Drug Development (Silver Spring, MD and webcast) - Hosted by FDA, the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA) to discuss progress and challenges in the development and advancement of various animal models for serious infection.
- November 18-19, 2019: Enhancing the Clinical Trial Enterprise for Antibacterial Drug Development (Silver Spring, MD and webcast) - Co-sponsored by FDA, IDSA, NIAID, and Pew, this workshop will bring together a diverse array of subject matter experts in the fields of infectious diseases (ID), academics and industry and other government bodies to better understand the current state of U.S.-based ID trials and how to enhance enrollment and research in such trials.
- October 16, 2019: Antimicrobial Drugs Advisory Committee public meeting (Silver Spring, MD and webcast) - The committee will discuss new drug application (NDA) 209445, cefiderocol lyophilized powder for intravenous administration, submitted by Shionogi Inc., for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis due to gram-negative bacteria in patients with limited or no alternative treatment options.
- July 12, 2019: Public meeting: Limited Population Pathway for Antibacterial and Antifungal Drugs (Silver Spring, MD and webcast). The purpose of the meeting is 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 that was published in the Federal Register on June 13, 2018. FDA is also reopening the comment period on this draft guidance for comments to be submitted for consideration before we finish work on the final version of the guidance. Submit comments by August 12, 2019.
- April 8, 2019: Public workshop: Development of Antibacterial Drugs for the Treatment of Nontuberculous Mycobacterial Infection (Silver Spring, MD and webcast) - to discuss the clinical trial design considerations, including endpoints, related to the development of antibacterial drug products for treatment of nontuberculous mycobacterial (NTM) disease.
- March 8, 2019: USFDA–CDSCO-DIA Workshop on Global Anti-Infective Drug Development: Challenges and Opportunities (Mumbai, India), hosted by DIA
- February 12, 2019: Webinar - Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices, 3:00 - 4:30 p.m. ET (materials and recording available)
- October 25-26, 2018: World Anti-Microbial Resistance Congress (Washington, DC) – FDA experts will present on topics including new pathways for antibacterial drug development (including LPAD); challenges in non-traditional development, stewardship and diagnostic approaches; and an update on FDA guidance for the coordinated development of antimicrobial drugs and antimicrobial susceptibility test devices.
- September 17, 2018: Science and Regulation of Live Microbiome-Based Products Used to Prevent, Treat, or Cure Diseases in Humans (Rockville, MD) - Public workshop to exchange information with the scientific community about the clinical, manufacturing, and regulatory considerations associated with live microbiome-based products, when administered to prevent, treat, or cure a disease or condition in humans - Also see: Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing the science and regulation of live microbiome-based products used to prevent, treat, or cure diseases in humans
- September 14, 2018: Live Event: FDA Unveils Plan to Combat Antibiotic Resistance (Washington, DC and webcast), hosted by the Pew Charitable Trusts, 10:00 - 11:30 a.m. ET - Commissioner Gottlieb to announce agency’s approach to antibiotic stewardship, innovation
- August 21-22, 2018: Development of Non-Traditional Therapies for Bacterial Infections public workshop
- June 27, 2018: Development of Inhaled Antibacterial Drugs for Cystic Fibrosis and Non-Cystic Fibrosis Bronchiectasis public workshop
- May 17, 2018: Vaccines and Related Biological Products Advisory Committee meeting to discuss approaches for demonstrating effectiveness of group B Streptococcus vaccines intended for use in pregnant women to protect the newborn infant
- November 7, 2017: Vaccines and Related Biological Products Advisory Committee meeting to discuss the clinical development of an investigational Staphylococcus aureus vaccine intended for pre-surgical prophylaxis in elective orthopedic surgical populations
- October 24, 2017: 2017 Scientific Meeting of the National Antimicrobial Resistance Monitoring System - Also see: FDA In Brief: Federal agencies meet to continue fight against antimicrobial resistance
- September 13, 2017: Antimicrobial Susceptibility and Resistance: Addressing Challenges of Diagnostic Devices public workshop to discuss the scientific and regulatory challenges associated with the efficient development of traditional devices for antimicrobial susceptibility testing (AST) and molecular or novel diagnostic technologies for the detection of antimicrobial resistance markers
- July 19, 2017: Development of New Tuberculosis Drug Regimens - Scientific and Clinical Design Considerations public workshop
- July 10, 2017: Bacteriophage Therapy: Scientific and Regulatory Issues public workshop
- April 13, 2017: Meeting of the Antimicrobial Drugs Advisory Committee to discuss the development of antibacterial drugs that treat a single species of bacteria when the target species infrequently causes infections
- March 1, 2017: Current State and Further Development of Animal Models of Serious Infections Caused by Acinetobacter baumannii and Pseudomonas aeruginosa public workshop
- September 7, 2016: Fighting antimicrobial resistance globally - EMA, FDA and PMDA discuss regulatory approaches for the evaluation of new antibacterial agents
Interagency collaboration to address AMR
FDA participates in and contributes to Combating Antibiotic-Resistant Bacteria (CARB), a Government-wide effort launched in 2014, including the work of:
- On October 9, 2020, the Interagency Task Force for CARB released the National Action Plan for Combating Antibiotic-Resistant Bacteria, 2020-2025, which presents coordinated, strategic actions that the United States Government will take in the next five years to improve the health and wellbeing of all Americans by changing the course of antibiotic resistance. This plan is based on the U.S. Government’s 2014 National Strategy for CARB, and builds on the first National Action Plan released in 2015 (PDF, 519 KB) by expanding evidence-based activities that have already been shown to reduce antibiotic resistance, such as optimizing the use of antibiotics in human and animal health settings.
- The Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB) that provides advice, information, and recommendations to the Department of Health and Human Services (HHS) Secretary related to combating AMR.
FDA’s Office of Public Health Strategy and Analysis (OPHSA) coordinates FDA’s involvement in CARB and represents FDA on PACCARB. Based on consultation with and input from FDA’s Centers, OPHSA routinely updates HHS on FDA’s progress in meeting National Action Plan goals, objectives, and milestones.
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