The Center for Science in the Public Interest (CSPI) has submitted comments to the FDA regarding the Reagan-Udall Foundation’s preliminary report on antimicrobial use monitoring.
This past spring, the Food and Drug Administration commissioned the Reagan-Udall Foundation to explore how the agency could collect antimicrobial usage data from farms to better understand and limit antimicrobial resistance stemming from this usage.
The Reagan-Udall Foundation is an independent organization created by Congress “to advance the mission of the FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation and enhance product safety.”
FDA and CSPI see antimicrobial monitoring as vital because antimicrobial usage in food animals can lead to the development of antimicrobial resistance in bacteria that harm humans.
The foundation evaluated the possibility of a private-public partnership to facilitate anonymous antimicrobial usage data collection from farms by the FDA. The report developed a series of principles it recommends be included in any data-collection system.
“Creating a system by which farmers and veterinarians can compare a farm’s antibiotic usage to usage by similar farms will foster the responsible use of these drugs,” says Dr. James Kincheloe, a veterinarian who used to work on production farms and is the Food Safety Campaign Manager at CSPI. “With such a system, farms will be better able to see where there may be inappropriate use, which is often a financial cost in addition to being a public health hazard.”
CSPI suggestions
- The FDA should ensure the proper components of antimicrobial use data be recorded on farms.
- The FDA should require that every farm record its usage data and that these data be made available to the agency for sampling.
- The FDA should develop a data collection system that enables farm comparison.
The CSPI agreed with the foundation’s evaluation that there is a need to collect data showing the nuances of how these antibiotics are being used, including animal species, size, and purpose of treatment. However, the CSPI recommended that this data collection be mandatory. The center suggests that these data would be held by producers, but FDA could sample a random set of producers on an annual basis to track antibiotic use in a more finely grained fashion than is possible with current practices. The agency could then provide updated, aggregated data in an annual report or on a website.
CSPI suggests that particular producers could use those data to see how their practices compare to overall industry practices. These data can also assist public health agencies in the development of policies to target usages that could be mitigated or modified to minimize the development of resistance.
To facilitate such comparisons, CSPI urged the FDA to require each farm to record its usage in a uniform manner, regardless of whether the FDA samples a farm’s data that year, and for the agency to release collected data in a manner that allows producers and veterinarians to compare their antimicrobial usage to their peers. The center added that standardized data collection and random sampling of a subset are necessary to avoid the biased data that are likely to result from a voluntary opt-in process.
The CSPI’s full comments can be found here.
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