Emergency Preparedness and Response

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: NIAIDAntimicrobial 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)

What's new

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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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:

The FDA is also working to advance the development of vaccines for organisms contributing to AMR.

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.

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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 Releases Annual Summary Report on Antimicrobials Sold or Distributed in 2017 for Use in Food-Producing Animals Showing Declines for Past Two Years (December 18, 2018)

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

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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.
  • The FDA is funding two 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.
  • The FDA is leveraging in vitro diagnostic device data standards to enhance real-time infectious disease/AMR surveillance.

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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.

Lab worker in the CDC-FDA AR Isolate Bank (image: CDC)

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.

The Center for Biologics and Evaluation and Research

The National Center for Toxicological Research’s Microbiology Division

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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.

  • 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)

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Information for consumers

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Press and statements

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Events

The following is a list of select recent and upcoming AMR-related events involving the FDA.

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Contact the FDA

Consumers and general information: contact FDA
You may also call 1-888-INFO-FDA / (1-888-463-6332)

Report a fraudulent product
Includes options for phone and online reporting

Press: contact the Office of Media Affairs
Email fdaoma@fda.hhs.gov or call 301-796-4540

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Page Last Updated: 03/05/2019
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