Establishing appropriate duration limits based on scientific data will help curb the emergence of resistance and preserve the effectiveness of antibiotics.
The Food and Drug Administration’s Guidance for Industry #213, which phased out growth promotion uses of medically important antibiotics and requires remaining antibiotic uses to have veterinary oversight, was fully implemented on Jan. 1. It marks an important milestone in efforts to ensure that antibiotics are used responsibly in food animals; however, 1 in 3 animal antibiotic labels still does not meet the agency’s judicious use standards, and further changes are needed.
To address one of the key ways in which many of these labels fall short, FDA has requested public comments on how to best establish appropriate duration limits—the maximum length of time for which a drug should be used—for antibiotics that lack them. Stakeholders have until March 13, 2017, to provide input.
Judicious use requires that antibiotics be administered only as long as needed to achieve the desired effect. This is important for minimizing the emergence of drug-resistant bacteria and is why Pew supports FDA’s efforts to establish evidence-based duration limits. It is likely that scientific evidence to establish such limits already exists for many products. It will be helpful to hear from a wide variety of stakeholders on how to update labels most efficiently, given the varying amounts of scientific information available for different products and the logistical challenges associated with revising a large number of labels.
In addition to requesting input on the best approach for updating the labels, FDA is also seeking other critically important information: how antibiotics without duration limits are used on farms; what factors influence veterinarians’ determinations about when and how to use these antibiotics; and which alternatives are available to manage animal health. This type of information will be essential to FDA in evaluating the importance of different products for managing animal health and developing evidence-based policy.
Establishing appropriate duration limits based on scientific data will help curb the emergence of resistance and preserve the effectiveness of antibiotics. Pew is committed to addressing this issue, as well as other ways in which labels still fall short of judicious use principles, and will submit public comments in support of FDA’s effort. Stakeholders should provide as much information as possible to help the agency advance evidence-based policies to improve responsible antibiotic use on farms.
Karin Hoelzer works on The Pew Charitable Trusts’ safe food and antibiotic resistance projects and is a veterinarian by training.