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Antimicrobial Resistance Information from FDA

Image
Scanning electron micrograph of methicillin-resistant Staphylococcus aureus (MRSA, brown) surrounded by cellular debris. MRSA resists treatment with many antibiotics. Credit: NIAID
Caption
Scanning electron micrograph of methicillin-resistant Staphylococcus aureus (MRSA, brown) surrounded by cellular debris. MRSA resists treatment with many antibiotics. (Credit: NIAID)

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

  • On April 23, 2021, FDA, NIAID, and CDC hosted a workshop to discuss the nonclinical and clinical pharmacology data and clinical trial design considerations regarding developing antimicrobial drugs for the treatment of gonorrhea, Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea (virtual). 
  • 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.
  • 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'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 June 11, 2021 (comment deadline extended).

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.

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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.

Recently cleared IVD devices, including Antimicrobial Susceptibility Test (AST) devices, include:

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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-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

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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.

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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.

Tools for scientists

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.

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.

For information about FDA-recognized antimicrobial susceptibility test interpretive criteria, visit http://www.fda.gov/STIC, and the corresponding Notice of Updates.

  • 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

FDA consumer updates

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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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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:

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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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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