The U.S. Food and Drug Administration (FDA) has published its fourth annual report summarizing the sales and distribution data of antimicrobial drugs approved for use in food-producing animals.
Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 105) requires antimicrobial drug sponsors to report to FDA on an annual basis the amount of antimicrobial drugs they sell or distribute for use in food-producing animals. ADUFA 105 also requires the FDA to prepare summary reports of sales and distribution information received from drug sponsors each year, by antimicrobial class for classes with three or more distinct sponsors, and to provide those summaries to the public.
Trends from 2009 through 2012 reflected in this year’s summary report include:
- The total quantity of medically important antimicrobials sold or distributed for use in food-producing animals increased by 16 percent over the period 2009-2012. The reason for the increase is unclear, according to FDA.
- Thirty-one percent of all antibiotics used in livestock and poultry production are classified as “ionophores.”
- The percentage of domestic sales and distribution of medically important antimicrobials that are approved for production use decreased from 72 percent to 68 percent. This number does not represent sales and distribution of drugs solely used for production because most of these products are approved for therapeutic (disease treatment, control or prevention) uses as well.
“Regarding this report, it is important to note that sales data does not necessarily correlate to national resistance trends,” the National Chicken Council (NCC) said in response. Regarding resistance trends, FDA on August 14, 2014 released its NARMS 2011 Executive Report, showing mostly decreasing antimicrobial resistance trends.
The NCC statement continued:
The majority of the FDA-approved antibiotics for chicken production are “animal only,” and not used in human medicine. There is small percentage of antibiotics that are currently approved by FDA for use in livestock and poultry, which also have use in human medicine. Their primary use is in raising broilers is to prevent a disease called necrotic enteritis – an infection in the bird’s intestine caused by the bacteria Clostridium. Along with coccidiois, necrotic enteritis is another of the two most potentially devastating bacterial diseases in modern broiler flocks. If not prevented, it can cause dehydration, loss of appetite, diarrhea and rapid death.
“Both FDA and the World Health Organization (WHO) rank antibiotics relative to their importance in human medicine. The highest ranking is “critically important.” Antibiotics in this category are used sparingly to treat sick birds. Antibiotics in other less-important classes may be used in chicken production to maintain poultry health and welfare, including for disease prevention, control and treatment purposes. Two classes of antibiotics that FDA deems critically important to human medicine, especially for treating foodborne illness in humans—flouroquinolones and cephalosporins—have already been phased-out of chicken production for a number of years.
“While minimally used in raising chickens, by December 2016, the rest of the antibiotics that are important to human medicine will be labeled for use in food animals only to treat and prevent disease, and will be used exclusively under the supervision and prescription of a veterinarian – a process supported by NCC. Preserving antibiotics’ effectiveness, both in humans and animals, is a responsibility chicken producers take seriously.
