The U.S. Government Accountability Office (GAO), the investigative arm of Congress charged with examining matters relating to the receipt and payment of public funds, wants the FDA and USDA to do more about antibiotic use in animal agriculture. The new report, titled “Antibiotic Resistance: More Information Needed to Oversee Use of Medically Important Drugs in Food Animals,” updates a similar analysis GAO conducted in 2011.
The report highlights three interrelated aspects of the antibiotic issue that are likely to fall under increased government scrutiny. These are:
1. Collection of more on-farm data on antibiotic use.
2. Antibiotic labels that do not specify duration of use.
3. Antibiotics used for prevention of disease, as opposed to control or treatment.
FDA’s Guidance for Industry 213, which took full effect on January 1 this year, removed label claims for production or performance enhancement for medically important antibiotics used in livestock. Thus, Guidance 213 removes most open-ended use of feed-grade antibiotics in livestock, but the report points out that some feed antibiotics used for disease prevention do not include limits for duration of use on their labels.
In September 2016, the FDA published a notice requesting public input on how to establish appropriate duration of use guidelines for those products. Specifically, the FDA asked for public input regarding:
· The underlying diseases requiring these drugs for therapeutic purposes, and periods when livestock or poultry are at risk of developing these diseases.
· More targeted antimicrobial use regimens for these diseases and husbandry practices that may help avoid the need for these antimicrobials, or that may help make more targeted antimicrobial use regimens more effective.
· Strategies for updating affected labeling of drug products that do not currently include a defined duration of use.
However, the GAO report says, “FDA has not clearly defined objectives for closing this gap, which is inconsistent with federal internal control standards. Without doing so, FDA will not know whether it is ensuring judicious use of antibiotics.”
The GAO report’s authors also point out gaps in collection of farm-specific data on antibiotic use and data on pathogens and resistance trends at the farm level. “Without metrics, FDA and APHIS cannot assess the effects of actions taken to manage the use of antibiotics,” they note.
The report includes these recommendations:
· 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.
· 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.
· 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.
· The Secretary of Agriculture should direct the Administrator of APHIS to develop performance measures and targets for collecting farm-specific data on antibiotic use in food animals.
· The Secretary of Agriculture should direct the Administrator of APHIS to develop performance measures and targets for collecting farm-specific data on antibiotic-resistant bacteria in food animals.
· 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.
Read the full GAO report.