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.

back to top

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.

back to top

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).

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

back to top

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.

back to top

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

  • 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 disclaimer icon - 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 disclaimer icon 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 disclaimer icon for information on application deadlines.

back to top

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

back to top

Information for consumers

back to top

Press and statements

back to top

Events

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

 back to top

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

back to top

 

Page Last Updated: 09/19/2018
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English