Committee Shoat Out: Pharmaceutical Issues Committee

July 28, 2021 — Abbey Canon

Committee Shoat Out: The Pharmaceutical Issues Committee continues to monitor swine practice drug issues, recommend actions to AASV members, and provide educational materials for members.

During 2020, the Pharmaceutical Issues Committee updated the Basic Guidelines of Judicious Use of Antimicrobials in Swine. During 2021, they plan to discuss and develop guidelines for the implementation of the five pillars of antimicrobial stewardship.

The Pharmaceutical Issues Committee continues to guide AASV in responding to FDA or other government officials during public commenting period. During 2020-2021, the AASV described the clinical importance of carbadox and encouraged FDA to use science-based decisions when considering revoking the approval method of carbadox. In response to a question FDA posed about transit and withdrawal times, the AASV provided answers to help FDA understand current industry practices and swine veterinarians' interpretation of labels. The AASV requested that future labeling be explicit and based in science and evidence. The AASV supported FDA's list of bulk drug substances for compounding drugs for poison antidotes for food-producing animals and requested that bulk drug substances used to compound drugs for depopulation and euthanasia be included on that list. The AASV reviewed the National Antimicrobial Resistance Monitoring System 2021-2025 Strategic Plan and submitted comments emphasizing and prioritizing pig health.

Much of the 2021 annual Pharmaceutical Issues Committee meeting was spent discussing FDA's proposed Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs. The AASV asked that FDA do the following:

• Work with veterinary medical and pharmaceutical stakeholders to develop a comprehensive guidance that considers relative antimicrobial importance to animals;
• Give consideration to the consequences of the adoption of such a ranking system and how groups may use this guidance to incentivize cessation of antimicrobial use in animals with approved, labeled, and effective antimicrobials;
• Update ranking system as relevant science and policy become available;
• Reassess the tier system with respect to risk of AMR development only for zoonotic microbes;
• Do not group medically and non-medically important antimicrobial drugs in the same tier; and
• Encourage pharmaceutical industry to develop and market antimicrobials considered not medically important.

Finally, the AASV responded to FDA's concept paper, the Potential Approach for Defining Durations of Use for Medically Important Antimicrobial Drugs Intended for Use In or On Feed. AASV described the significant impact this guidance would have on swine veterinarians' ability to practice veterinary medicine and protect the health and welfare of the animals under our care if accepted in the concept paper's current format.

The Pharmaceutical Issues Committee will meet virtually August 6, 2021, 3:00-5:00pm CT.

Interested in joining the committee? Contact Dr. Abbey Canon, Director of Public Health and Communications.

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Abbey Canon is the AASV Director of Public Health and Communications