Recommendation: The Secretary of Health and Human Services should direct the Commissioner of FDA to develop a process, which may include time frames, to establish appropriate durations of use on labels of all medically important antibiotics used in food animals.

Agency: Department of Health and Human Services
Status: Open

Comments: In July 2017, as part of the agency's formal comments, HHS initially neither agreed nor disagreed with the recommendation. Subsequently, in a September 2017 letter, HHS agreed with this recommendation. In July 2018, HHS stated that FDA published a notice in the Federal Register In September 2016 requesting information from the public about how to establish appropriately targeted durations of use for therapeutic products affected by Guidance for Industry #213 with no defined duration of use. According to HHS, FDA evaluated the comments received and plans to develop a strategy to address this issue. In July 2019, HHS stated that FDA published a Request for Applications on April 1, 2019 for study proposals to help establish more targeted or defined durations of use for approved medically important antimicrobial drugs used in the feed of food-producing animals. There are currently no such products approved for use in water with an undefined duration of use. According to HHS, due to significant scientific and technical challenges, FDA anticipates that this initiative will require substantial time to fully implement so the primary objective is to update product dosage regimens to better target when and for how long the drug may be used.

Recommendation: The Secretary of Health and Human Services should direct the Commissioner of FDA to establish steps to increase veterinary oversight of medically important antibiotics administered in routes other than feed and water, such as injections and tablets.

Agency: Department of Health and Human Services
Status: Open

Comments: In July 2017, as part of the agency's formal comments, HHS initially neither agreed nor disagreed with the recommendation. Subsequently, in a September 2017 letter, HHS agreed with this recommendation. In July 2018, HHS stated that FDA recognizes that a limited number of medically important antimicrobial products, available in dosage forms other than feed or water (e.g., injectable), continue to be marketed as OTC products and the agency intends to work with the sponsors to put these products under veterinary oversight. In July 2019, HHS stated that FDA released a broad 5-year plan in September 2018 outlining steps to support stewardship of medically important antimicrobials in veterinary settings. As part of that plan, FDA intends to publish a draft strategy, likely in the form of draft guidance for industry, to bring all dosage forms (such as injectables and tablets) of medically important antimicrobial drugs under veterinary oversight. The draft strategy will also provide a framework, including proposed timelines, for transitioning from over-the-counter to prescription marketing status for all approved medically important antimicrobial drugs that are not yet subject to veterinary oversight. FDA plans to issue this draft strategy no later than the end of fiscal year 2019. In conjunction with issuing the draft strategy, FDA intends to publish a list of affected new animal drug applications.

Recommendation: The Secretary of Health and Human Services should direct the Commissioner of FDA to develop performance measures and targets for actions to manage the use of antibiotics such as revising the veterinary feed directive and developing guidance documents on judicious use.

Agency: Department of Health and Human Services
Status: Open

Comments: In July 2017, as part of the agency's formal comments, HHS initially neither agreed nor disagreed with the recommendation. Subsequently, in a September 2017 letter, HHS agreed with this recommendation. In July 2018, HHS noted that FDA has taken steps to develop performance measures and targets. According to HHS, FDA issued a final rule in May 2016 revising annual reporting requirements for drug sponsors of antimicrobials sold or distributed for use in food-producing animals to obtain estimates of sales broken out by major food-producing species (i.e., cattle, swine, chickens, and turkeys). Additionally, in August 2017, FDA published a paper proposing the use of a biomass denominator to adjust annual data on the volume of antimicrobials sold or distributed for use in food-producing animals in the United States. According to HHS, this adjusted estimate will provide insight into broad shifts in the volume of antimicrobials sold for use in food-producing animals. FDA is also funding two grants for antimicrobial use 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 (i.e., cattle, swine, chickens, and turkeys), which is a critical element in measuring overall impact of the agency's judicious use strategy. FDA expects these data collection efforts to provide important information on methodologies to help optimize long-term strategies to collect and report such antimicrobial use data. In addition, FDA has been working in close collaboration with USDA, including providing input on recent surveys administered by USDA to collect information on antimicrobial use on farms. In July 2019, according to HHS, FDA agrees that performance measures and targets are needed to help gauge the success of antimicrobial stewardship efforts. While the agency continues to work on developing such measures and targets, FDA reported a decrease in domestic sales and distribution of all medically important antimicrobials intended for use in food-producing animals (e.g. decreased by 33 percent from 2016 through 2017). HHS noted that the reduction in sales volume is an important indicator that ongoing efforts to support antimicrobial stewardship are having a significant impact even though sales data do not necessarily reflect antimicrobial use.

Recommendation: The Secretary of Agriculture should direct the Administrator of APHIS and the Administrator of the Food Safety and Inspection Service to work with the Director of CDC to develop a framework for deciding when on-farm investigations are warranted during outbreaks.

Agency: Department of Agriculture
Status: Open

Comments: USDA agreed with this recommendation. In August 2018, USDA's Animal and Plant Health Inspection Service (APHIS) stated that it is working closely with USDA's Food Safety and Inspection Service (FSIS) and HHS' Centers for Disease Control and Prevention (CDC) to develop a framework for deciding when on-farm antimicrobial resistance investigative activities are warranted. In September 2019, according to APHIS officials, the lead agencies, including APHIS, FSIS, and CDC, have agreed that it is imperative that cross sector partners from a range of animal agriculture industries be included in developing the framework that was requested in GAO's final report. A framework for making decisions regarding on-farm antimicrobial resistance investigative activities simply will not work without including industry sector partners in the development of the framework, according to APHIS officials. Due to the logistics of getting all of the cross sector partners together, APHIS is unable to schedule the next meeting in the series to develop the Pre-Harvest Framework until December 2019. APHIS anticipates that it will take the remainder of fiscal year 2020 to work through additional meetings with partners and finalize this framework.