Animal Health Industry Working with FDA on Judicious Use of Antibiotics

The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) today published draft Guidance for Industry #263 outlining a process for animal health companies to make label changes to bring all medically important antibiotics used in food animals under veterinary supervision. The animal health industry and CVM worked cooperatively to implement previous Guidance for […]

AHI Joins Groups in Supporting One Health Approach to Antimicrobial Resistance

The Animal Health Institute joined health care providers, scientists, patient and public health advocates in sending a letter to Secretary of Health and Human Services Azar in support of efforts to combat antimicrobial resistance. In calling for “well-coordinated efforts across human health, animal health and the environment,” the letter recognizes the value of a One […]

Compounded Unapproved Animal Drugs Linked to Horse Deaths – Again.

July 24, 2019 — The Food and Drug Administration announced this week that horses in regionally diverse parts of the country died or were euthanized as a result of the use of compounded drugs. It’s not the first time.  FDA also cited the death of four horses in 2014 as a result of an erroneously […]

AHI Comments About Alternative Approaches in Clinical Investigations for New Animal Drugs

July 16, 2019 – AHI participated in the FDA Center for Veterinary Medicine’s public meeting about alternative approaches in clinical investigations for new animal drugs. The meeting included four sessions that focused on the following topics: (1) complex adaptive and other novel investigation designs; (2) data from foreign countries; (3) real-world evidence; and (4) biomarkers […]

AHI STATEMENT: FDA Report on Sales of Antibiotics for Use in Food Producing Animals

Washington, DC – December 7, 2017 – Antibiotic sales – whether they go up or down – are not predictors of public health impact. While today’s sales report is an interesting piece of the story, we are more encouraged by the recent data from the National Antimicrobial Resistance Monitoring System that shows that for those pathogens that might transfer from animals to humans, resistance rates in people have been stable or declining.