Developing new regulatory approaches to antimicrobial safety

Area of Science:

• Veterinary Medicine
• Public Health
• Microbiology

Background:

• Antimicrobial resistance (AMR) in food-producing animals is a significant global public health issue.
• Resistant bacteria from animals can cause food-borne infections in humans, threatening effective human antimicrobial therapies.
• The US Food and Drug Administration (FDA) is actively addressing the public health impact of antimicrobial drug use in food animals.

Purpose of the Study:

• To outline the FDA's approach to managing antimicrobial resistance risks associated with new animal drugs.
• To ensure the continued efficacy of critical human antimicrobial treatments.
• To provide a framework for drug sponsors to assess and mitigate microbiological risks.

Main Methods:

• The FDA utilizes a qualitative risk assessment approach.
• This process evaluates the potential for drug use to promote resistance in bacteria relevant to human health.
• Risk management strategies are determined by the assessed level of risk.

Main Results:

• A guidance document, 'Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to their Microbiological Effects on Bacteria of Human Health Concern,' was published.
• The guidance provides a pathway for drug sponsors to address antimicrobial resistance concerns before drug approval.
• The FDA retains the authority to deny approval if public health risks are deemed too high.

Conclusions:

• The FDA's risk-based framework aims to balance the safe use of antimicrobials in food animals with the protection of human health.
• Proactive assessment and management of antimicrobial resistance are crucial for preserving the effectiveness of human medicines.
• The FDA's commitment is to prevent the compromise of vital antimicrobial therapies due to resistance development in animal agriculture.