The US Food and Drug Administration (FDA) has published a concept paper today to obtain early input from the public on a potential framework for how antimicrobial producers 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 products lacking such classification.
The consultation focuses on medically important antimicrobial drugs administered through the medicated feed used in livestock and poultry production, said the FDA. These products can only be used with the order of a licensed veterinarian.
The US agency estimates around 28% of all medically important antimicrobials approved for administration through animal feed in the US do not have defined durations of use. “Defining durations of use for those uses of medically important antimicrobials in medicated feed that currently lack them will allow for the effective use of these products,” said the regulator.
The FDA is accepting public comments on the consultation until April 12, 2021.
“The concept paper is intended to facilitate public comment on a potential voluntary approach to defining durations of use and does not contain any recommendations or guidance,” it stressed,
The agency said it will consider all information and comments received on the concept paper before issuing draft guidance for additional public comment.
In April 2019, the Pew Charitable Trusts argued that slowing the emergence of resistant bacteria requires appropriate use of antibiotics in all settings, including animal agriculture.
“However, many medically important antibiotics can still be legally given to animals in ways that do not meet the FDA’s definition of judicious use. For example, many antibiotic labels allow for very long or undefined durations of use, meaning that they can be given to animals for weeks or months, or even indefinitely. Additionally, some duration limits are tied to subjective or poorly defined external factors, such as when the animal experiences 'times of stress.'
"As the FDA works to establish appropriate, science-based duration limits for all antibiotics as part of its five-year plan to improve antibiotic use in food animals, the agency must prioritize these efforts based on factors such as each drug’s importance to animal health.”