FDA Must Establish Limits for All Animal Antibiotics

Defined durations are important for animal and public health, key to combating resistant bacteria

 

The Pew Charitable Trusts

April 29, 2021

 

Overview

 

Antibiotic use in any setting—including animal agriculture—contributes to the emergence of drug-resistant bacteria, a dangerous and growing global health threat.1 Of particular concern is the overuse of medically important antibiotics—those that are also essential to human health care—in food animals, which accelerates the development of resistance to these critical drugs. Despite widespread agreement among animal and public health experts and clear guidance from the Food and Drug Administration that antibiotic use without limits is not judicious, 1 in 3 of such drugs approved for use in agriculture can be administered for excessively long or undefined periods of time.2 In fact, available evidence suggests that time frames for antibiotics use can exceed five consecutive months in some food-producing animals.3 According to FDA’s guiding principles, injudicious use of medically important antibiotics is any use beyond that necessary to assure animal health—which includes, but is not limited to, inappropriate long-term use of antibiotics. Such injudicious use presents a clear and serious public health risk, and federal action is long overdue.

 

In 2018, FDA announced a five-year plan to curb the spread of antibiotic-resistant bacteria, which included a commitment to ensuring that medically important antibiotics used in animals have limited and defined durations of use. Subsequently, FDA identified a list of animal antibiotics that lack duration limits and released a preliminary proposal outlining how the agency would work with drug sponsors—the companies responsible for drug marketing and compliance with FDA regulations—to establish defined durations for these drugs. The proposed process, however, is insufficient because it allows drugmakers to use a range of standards in place of clear and specific duration limits; lacks clear guidance for medically complex diseases that frequently lead to prolonged or indefinite antibiotic use; and gives drug sponsors too lengthy a timeline to update their products.4

 

An analysis by The Pew Charitable Trusts identified several actions that FDA should incorporate in order to establish duration limits in a clear, comprehensive, and timely manner. By leveraging existing data from clinical studies for approved drugs, working with drug sponsors to identify data gaps, and supporting targeted new research to establish effective minimum durations of treatment, FDA can still achieve its goal of establishing duration limits before the close of the five-year plan in 2023.

 

What Are Duration Limits, and Why Are They Important? ...

 

How to Address a Lack of Duration Limits ...

 

When existing information can establish a duration limit ...

 

When similar products with duration limits can be substituted ...

 

When FDA should work with drug sponsors to acquire the additional data needed ...

 

Additional Considerations

 

Complex animal diseases ...

 

Withdrawal of approval ...

 

Next Steps ...

 

Methodology ...

 

Endnotes ...

 

more, including links  

https://www.pewtrusts.org/en/research-and-analysis/issue-briefs/2021/04/fda-must-establish-limits-for-all-animal-antibiotics