Veterinary Pharmacology, Antimicrobials, AMDUCA and Research, oh my!

Welcome back to the YourCareerEdge Blog. Here’s another contribution from Rob Hunter, animal health lead instructor and advisor on the topic of animal health regulatory affairs.

Yes, we are still in Kansas, though sometimes I wonder. This will be a blog about the 3-legged stool of academia, industry and regulatory affairs. A commentary (Prescott, J.F., Martinez, M.N., Turnidge, J., & Page, S.W. (2021) The publication of studies involving the use of human critically important antimicrobial agents in veterinary species. Journal of Veterinary Pharmacology and Therapeutics, 00, 1–4. was recently published online. In full disclosure, I am a member of the Editorial Board of JVPT. This commentary details if, when and how certain antimicrobial agents and the research involving them should be published in the veterinary literature. It describes several definitions of critically important antimicrobials and then expresses opinions regarding how veterinary journals should treat and evaluate research that is submitted to them for publication. The authors take the view essentially that limited or censoring certain research supports judicious use and may lead to decrease in antimicrobials resistance development.

Acceptance of manuscripts by a veterinary journal indicates an editorial determination that the information being conveyed is scientifically sound and supports the safe and effective development and use of veterinary therapeutics.” I agree with part of this statement that manuscripts published by an individual journal convey scientifically sound principals. However, it is not a journal’s role to determine if the research has an involvement or role in the “safe and effective development and use of veterinary therapeutics.” A journal can and should deal with the science and quality of research described and detailed in a manuscript. It is the READERS’ responsibility to decide if, when and how this information is used. Judicious use of antimicrobials is not just about not using certain agents, it is also about knowing when the appropriate time and place is to use them and to use them with appropriate knowledge and guidance. Without information and data, it is not judicious use, it is just use. 

To remined readers of this blog, the Animal Medicinal Drug Use Clarification Act of 1994 (commonly referred to as AMDUCA) allows veterinarians to use approved animal and human products in an extra-labeled manner when based on sound clinical judgement. Here is the link to the text of the AMDUCA legislation ( AMDUCA precludes the use of in certain instances and can only be done by a licensed veterinarian of an approved human or animal product. There is a list of currently prohibited drugs for extra-label use in food animals provided here:

While CVM/FDA has the authority to prohibit extra-label use in companion animals should there be a perceived threat to human health, this has been not been done to date. I raise that as it is the CVM/FDA’s purview to do so. It seems inappropriate and outside of a regulatory body’s authority to publish a commentary (one of the authors is a senior scientist with CVM/FDA) instead of pursuing regulatory options regarding this topic.

I also consider this an animal welfare issue. Dogs and cats have become an integral part of many families. We know that during the COVID pandemic we are all living, at the start many animal shelters were devoid of animals to adopt as humans searched for companionship that they could not obtain due to local and regional shutdowns and confinements. To not conduct and publish peer-reviewed, quality research puts the care of these animals at risk. One could argue that publishing the research promotes the use of critically important antimicrobials, but the lack of information promotes the potential lack of care a pet could, should or can receive and increase the potential for adverse events, which could be toxicity but may also be a lack of efficacy, which is one of the issues I believe the commentary is trying to avoid, a corresponding increase in bacterial resistance to these antimicrobials. 

To allow these animals to not have access to appropriate, responsible therapy is not an acceptable outcome to me. We want our family members and pets to have safe and effective treatments. The animal health market does not and cannot financially support the approval of every human drug for use in veterinary medicine, hence AMDUCA was created and legalized in the first place. The approval of generic human versions of antimicrobials can and does lead veterinarians to using these products under AMDUCA. It has been reported that when an antimicrobial agent becomes genericized, either human or veterinary, its use correspondingly increases ( Lack of published research could cause misuse of these agents if what the authors of the paper referenced are most concerned about, the publishing of data in animals regarding certain antimicrobial agents. 

I leave readers with the thought that we should seriously consider revisiting generic antimicrobial approval legislation as a potential way to address this issue instead of trying to prohibit the publishing of research that can assist with how an antimicrobial should or should not be used.

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