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1980's - All new medically important antibiotics have been approved with veterinary oversight.
1993 to present - New applications for medically important antimicrobials used in food-producing animals have only been approved as VFD or prescription products. Both marketing status designations require a veterinarian to be involved in decisions about when and how to use these products in animals.
1996 - Together with two other federal partners (USDA and CDC), CVM established the National Antimicrobial Resistance Monitoring System (NARMS) program. Since 1996, the program has undergone several enhancements. For example, NARMS revised its animal sampling structure in 2013 to obtain more representative animal data on all four target organisms under surveillance (Salmonella, Campylobacter, Escherichia coli, and Enterococcus).
1997 - Prohibited extralabel use of fluoroquinolones and glycopeptides (FR Doc No: 97-13677). Note: While other countries approved the glycopeptide, avoparcin, for use in food-producing animals, this class was never approved or marketed for such uses in the U.S.
2003 - FDA established industry guidance for assessing antimicrobial resistance risks as part of the drug approval process (Guidance for Industry #152, FR Doc No: 03-27113). This guidance also established a qualitative risk assessment approach for evaluating the microbial food safety of antimicrobial new animal drugs as part of the new animal drug approval process.
2005 - FDA incorporated a step-wise approach into the pre-approval process to evaluate the effect of antimicrobial residues on human intestinal flora into the pre-approval safety assessment of agents for food-producing animals; one of the end points of concern is the increase of antimicrobial resistant bacteria. (Guidance for Industry #159, Docket ID: FDA-2003-D-0433).
2010 - Initiated judicious use effort with issuance of draft Guidance #209 (Docket ID: FDA-2010-D-0094).
2010 - Published the first annual summary report of antimicrobials sold or distributed for use in food-producing animals in accordance with section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA Reports).
2012 - Prohibited certain extralabel uses of cephalosporins (FR Doc No: 2012-35 [Final Rule]; Docket ID: FDA-2008-N-0326). Note: 4th generation cephalosporins have never been approved for use in food-producing animals in the U.S.
2012 - Published final Guidance for Industry #209, which established a framework for ending production uses (e.g., increased rate of weight gain and improved feed efficiency) of medically important antimicrobials and brought the remaining therapeutic uses of such drugs in food-producing animals under veterinary oversight.
2012 - Published draft Guidance #213 (Docket ID: FDA-2011-D-0889), in which CVM provided more detailed guidance to sponsors regarding how to align their antimicrobial drug products with GFI #209 recommendations. More specifically, the guidance defined which drug products are affected and established a three-year implementation timeline.
2012 & 2013 Solicited public input on data collection and reporting related to antimicrobial use in food-producing animals. In response to the comments received on reporting, FDA proposed additional tables to enhance annual summary reports of antimicrobials sold for use in food-producing animals (Docket ID: FDA-2012-N-0447).
2013 - FDA revised its animal sampling structure in NARMS to get more representative animal data on all four target organisms under surveillance
2014 - First publication of annual summary report of antimicrobials sold for use in food-producing animals in expanded format (ADUFA Reports).
2014 - NARMS implements whole genome sequencing and uploading of the information to the public database at NCBI.
2015 - FDA issued the Veterinary Feed Directive (VFD) final rule, which governs how veterinarians authorize the use of VFD-designated animal drugs in feed. The revised regulation improves the efficiency of the VFD process, a critical step to facilitate implementation of GFI #213 to transition the marketing status of antimicrobial drug products from OTC use to VFD use under the direction of a licensed veterinarian (veterinary oversight).
2015 - Concurrent with the publication of the final rule updating the VFD regulation in June 2015, CVM developed a VFD inspection framework to assist field personnel as they conduct inspections of the various parties involved in the VFD process (veterinarians, distributors, and animal producers). This inspection framework looks at VFD orders, requirements for the parties involved, and recordkeeping. Our intent is to phase in compliance activities related to the VFD rule over time, with the initial phases devoted heavily to educating feed mills, retailers, veterinarians, and animal producers about VFD requirements.
2016 - Announced a funding opportunity for antimicrobial use and resistance data collection. These collection efforts are intended to provide part of the baseline information on antimicrobial use practices in the four major food-producing animal groups (cattle, swine, chickens, and turkeys), a critical element in measuring overall impact of the agency’s judicious use strategy. We also expect the data collection efforts to provide important information on methodologies to help optimize long-term strategies for collecting and reporting such data.
2016 - Approved the first alternative to an antimicrobial drug, Imrestor. Imrestor was also the first animal drug for use in food-producing animals simultaneously reviewed and approved in both the United States and Canada.
2016 - Sought public input on establishing appropriately targeted durations of therapeutic use of medically important antimicrobial drugs in food-producing animals.
2016 - Issued a final rule revising the annual reporting requirements for drug sponsors of antimicrobials sold or distributed for use in food-producing animals. The additional data CVM will gather as a result of this rulemaking will improve our understanding of how antimicrobials are sold or distributed for use in the four major food-producing species and help further target efforts to ensure judicious use of medically important antimicrobials.
2016 – FDA, in collaboration with USDA, initiated planning activities and surveys of laboratory network partners to begin projects to fulfill the presidential CARB goals which named Vet-LIRN and NAHLN networks to conduct AMR testing of select animal pathogens and expand sequencing capabilities of network laboratories.
2017 - Completed implementation of GFI #213. This process transitioned medically important antimicrobial drugs used in the feed or drinking water of food-producing animals from over-the-counter status to VFD or prescription status requiring veterinary oversight and eliminated production uses (e.g., growth promotion). This represents a significant change to how antimicrobials had been used for decades in food animals.
Of the 292 new animal drug applications initially affected by GFI #213:
Of the 208 remaining applications:
84 were completely withdrawn
93 applications for oral dosage form products intended for use in water were converted from over-the-counter to prescription status
115 applications for products intended for use in feed were converted from over-the-counter to veterinary feed directive status
Production (e.g., growth promotion) indications were withdrawn from all (31) applications that included such indications for use
2017 - Published a paper proposing the use of a biomass denominator to adjust annual data on the amount of antimicrobials sold or distributed for use in food-producing animals in the United States. This adjusted estimate will provide insight into broad shifts in the amount of antimicrobials sold for use in food-producing animals and give the agency a more nuanced view of why sales increase or decrease over time in a manner that is specific to U.S. animal production. Such analysis will also support our ongoing efforts to encourage the judicious use of antimicrobials in food-producing animals to help ensure the continued availability of safe and effective antimicrobials for animals and humans.
2017 - Along with its NARMS partners CDC and USDA’s Food Safety and Inspection Service, released a new format for the 2015 NARMS Integrated Report. The annual report highlights antimicrobial resistance patterns in bacteria isolated from humans (by CDC), raw retail meats (by FDA), and animals at slaughter (by USDA). The report also provides information derived from whole genome sequence data about resistance genes for all Salmonella and some Campylobacter isolates. The report includes NARMS Now, a set of interactive data tools that allow users to explore the dynamics of antibiotic resistance and the genes involved. While overall resistance remains low for most human infections and there have been measurable improvements in resistance levels in some important areas, NARMS is closely monitoring a few areas of concern.
2017 - Launched Resistome Tracker, an interactive research and data visualization tool for antibiotic resistance genes.
2017 - CVM’s Vet-LIRN network conducted a Pilot AMR-CARB project which consisted of 20 Source laboratories which isolated 3 prioritized pathogens and conduct AMR testing monthly. Approximately 1500 isolates were tested. Vet-LIRN provided sequencers, training and project funds to 4 WGS laboratories who sequenced approximately 150 isolates collected by the Source laboratories. Data was transferred to CFSAN GenomeTrakr for quality control evaluation and uploading to NCBI, a public database.
2017 - A subcommittee of the FDA Science Board reviewed the NARMS program and made recommendations to adopt a One Health framework for surveillance.
2018 - CVM released a Five-Year Plan for Supporting Antimicrobial Stewardship in Veterinary Settings. This plan builds upon the important steps CVM has taken to eliminate production uses of medically important antimicrobials (i.e., antimicrobials important for treating human disease) and to bring all remaining therapeutic uses of these drugs under the oversight of licensed veterinarians. It also supports the judicious use of antimicrobials in food-producing animals and is driven by the concept that medically important antimicrobial drugs should only be used in animals when necessary for the treatment, control or prevention of specific diseases
2018 - CVM’s Vet-LIRN network continued its Pilot AMR CARB project of 20 Source laboratories which isolated 3 prioritized pathogens (Salmonella and Staphylococcus pseudointermedius and conducted AMR testing monthly. Over 2500 isolates were tested. Vet-LIRN provided sequencers, training and project funds to 4 WGS laboratories who sequenced Over 800 of the isolates collected by the Source laboratories. Data was made publicly available by uploading to NCBI, via CFSAN’s GenomeTrakr.
2019 – CVM issued Revised Question & Answer Draft Guidance on Veterinary Feed Directive Regulation to aid industry in complying with the requirements of the Veterinary Feed Directive (VFD) final rule published in June 2015, and serves as a Small Entity Compliance Guide.
2019 – CVM 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.
2019 - CVM’s Vet-LIRN network began its AMR Monitoring Program based on the previous 2-year Pilot Projects. The Program expanded the number of participating laboratories from 20 to 25 Source AMR testing laboratories and to 5 (from 4) WGS sequencing Laboratories. Testing was expanded from 3 prioritized pathogens to 4. Approximately 3000 isolates will be tested and 1000 of those will be sequenced. Data will continue to be made publicly available by uploading to NCBI, via CFSAN’s GenomeTrakr. Vet-LIRN will also be setting up a Vet-LIRN Antimicrobial Working Group to develop stewardship response recommendations for network laboratories that find bacterial pathogens that are highly resistant.
2019 – CVM releases draft guidance #263 to explain the recommended process for voluntarily bringing 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 (OTC) to prescription (Rx).
2020 – CVM announced a new Fiscal Year 2020 funding opportunity and Request for Applications to support the collection of data on antimicrobial use in dogs and cats. Data collected will support efforts to assess potential associations between antimicrobial use practices in dogs and cats and antimicrobial resistance. The data collected are also expected to provide information on data collection methodologies to help optimize long-term strategies for collection and reporting of antimicrobial use in dogs and cats.
2020 - CVM released the NARMS Strategic Plan. The NARMS Strategic Plan: 2021-2025 lists the program’s strategic goals and objectives, as well as its challenges and opportunities. A central theme of the new NARMS Strategic Plan is One Health, which is a collaborative, multisectoral, and transdisciplinary approach to health—working at the local, regional, national, and global levels—with the goal of achieving optimal health outcomes recognizing the interconnection between people, animals, plants, and their shared environment.
2020 - CVM announced a potential revised process and criteria for ranking antimicrobial drugs based on their importance in human medicine. To describe these potential revisions in detail, FDA published a concept paper, and issued a Request for Comments in the Federal Register, to obtain early public feedback on the content of the paper. FDA also held a public meeting to present the details and receive additional comments.
2020 – CVM released the 2018 NARMS Integrated Summary which combines antimicrobial resistance data in bacteria isolated from humans (by CDC), raw retail meats (by FDA), and animals at slaughter (by USDA) to examine trends in resistance to the most important antimicrobial agents. The 2018 NARMS Integrated Summary also describes enhancements to NARMS in three areas: new animal pathogen data collected, antimicrobials tested, and retail meat collection sites.
2021 – CVM has 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 to establish a defined duration of use for those indications that currently lack a defined duration of use. FDA also published a notice in the Federal Register that invites the public to comment on specific questions regarding the concept paper.
2021 – CVM finalized guidance for industry (GFI) #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 change is made, these important drugs can only be used in animals under the supervision of a licensed veterinarian. To provide additional information to impacted stakeholders, CVM also published frequently asked questions for Farmers and Ranchers and additional materials to support veterinary oversight:
2021 - CVM has asked the Reagan-Udall Foundation for the FDA to seek input from a variety of affected stakeholders about strategies for collecting data regarding antimicrobial use in food-producing animals. This project is an important opportunity to consider strategies for collaboration between the public and private sectors. CVM hopes that through this stakeholder dialogue, it can learn about capabilities and challenges facing the veterinary, agricultural, and public health communities when it comes to collecting and sharing antimicrobial-use data. Based on the input received during the stakeholder engagement, the Foundation published a report and hosted a public webinar in spring 2022 to present its findings. In addition, CVM expects to open a public docket to receive further public comment on the report.
2022 – CVM announced two Fiscal Year (FY) 2022 funding opportunities which could provide up to $800,000 in support of antimicrobial stewardship in veterinary settings and reducing antimicrobial resistance in animal agriculture. For the first grant opportunity, between February 1, 2022 and April 1, 2022, the FDA will accept research applications to help identify potential alternative practices for reducing the reliance on antimicrobial drugs for addressing the health needs of food-producing animals. For the second grant opportunity, between March 1, 2022 and May 2, 2022, the FDA will accept applications for developing educational strategies for disseminating information on antimicrobial resistance and on implementing antimicrobial stewardship practices in food-producing animals.
2022 – CVM released a request for public comments about antimicrobial use (AMU) in companion animals (e.g., cats, dogs, horses) and the potential impact of this use on antimicrobial resistance in both animals and people. The FDA’s Center for Veterinary Medicine (CVM) intends to use the information collected to help develop strategies to further promote antimicrobial stewardship in companion animals. The FDA is accepting public comments on “Request for Public Input on Antimicrobial Use in Companion Animals for the Center for Veterinary Medicine; Request for Comments” until June 16, 2022.
2022 – CVM issued a draft update to guidance for industry (GFI) #152, “Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern.” The guidance is a tool for assessing the risk of antimicrobial resistance (AMR) in people, which could result from the use of a medically important antimicrobial drug in food-producing animals. Updates to the guidance include revisions to the risk assessment framework, updated ranking criteria for determining the degree of medical importance of antimicrobial drug classes, and a revised ranking of antimicrobial drug classes as critically important, highly important, or important based on the newly updated ranking criteria (Appendix A). To provide additional information to impacted stakeholders, CVM also published Questions & Answers: Draft Revised GFI #152.
2022 - CVM launched an Interactive Summary of Biomass-Adjusted Antimicrobial Sales Data. The display applies a biomass denominator to adjust existing annual antimicrobial sales and distribution data for medically important antimicrobial drugs sold or distributed for use in food-producing animals (cattle, swine, chickens, and turkeys) in the United States for years 2016 to 2021.
August 2023 – CVM opened a docket to seek public comment on a report outlining a potential framework for establishing a public-private partnership (PPP) to collect and analyze antimicrobial use (AMU) data from food-producing animals. The report was prepared for the FDA by the Reagan-Udall Foundation (the Foundation) and summarizes the work completed over a multi-year cooperative agreement funded by the FDA.
September 2023 – CVM released a draft guidance for industry (GFI) to provide recommendations on how animal drug sponsors may voluntarily establish a defined duration of use for certain approved medically important antimicrobial animal drugs with indications that currently lack a defined duration of use.
December 2023 – CVM began a new interactive dashboard for displaying the annual sales and distribution data for antimicrobials approved for use in food-producing animals.
December 2023 - CVM announced the issuance of nine warning letters to manufacturers and distributors of unapproved and misbranded antimicrobial animal drugs for violations of federal law.
March 2024 - CVM offered a funding opportunity to support the collection of antimicrobial use data from diverse animal sectors. The cooperative agreements provide up to three awards in fiscal year (FY) 2024 for a total of $600,000, and up to five awards in FY 2025 for a total of $1,000,000. The funding opportunities are the FDA’s latest step toward collecting information about the use of antimicrobials in animals.
