FDA Report on Antimicrobial Sales & Distribution Rise

Jamie JohansenAg Group, Animal Health, Antibiotics, FDA

FDAThe Food and Drug Administration has published its annual report summarizing the sale and distribution of antimicrobial drugs approved for use in food-producing animals. From calendar year 2013-2014, the reports shows a four percent increase for all antimicrobials and three percent increase in those medically important to human medicine.

The summary report reflects sales and distribution information for 2014, the year after the FDA’s announcement of its judicious use strategy for antibiotics that are important in human medicine and are also used in feed or water of food-producing animals. The FDA’s Guidance for Industry #213 specifies a timeframe of three years, until December 2016, which is the date by which drug sponsors have voluntarily agreed to make label changes to the affected products to remove production indications (growth promotion and feed efficiency) and move the products from over-the-counter availability to veterinary feed directive or prescription status in order to ensure the remaining therapeutic uses for the treatment, control or prevention of a specifically identified disease will be under veterinary oversight. To date, three applications have been converted from over-the-counter to prescription dispensing status; production indications have been withdrawn from one application; and 32 affected applications have been completely withdrawn. The FDA expects that drug sponsors will complete the remaining changes before January 2017.

A statement from the Animal Health Institute called the report “a small part of the story about the public health impact of antibiotics used to keep food animals healthy,” pointing out that “sales data does not represent actual use.”

“It is also important to note that significant progress continues in the effort to implement FDA’s judicious use policy, designed to eliminate the use of medically important antibiotics for growth promotion and place all remaining uses under veterinary oversight,” the group said. “When fully implemented one year from now, medically important antibiotics will be used in food animals only to fight disease under the supervision of a veterinarian.”