17 December 2013

3 minute read

North America

The US Food and Drug Administration (FDA) has implemented a plan to help phase out the use of medically important antimicrobials in food animals for food production purposes, such as to enhance growth or improve feed efficiency. The plan would also phase in veterinary oversight of the remaining appropriate therapeutic uses of such drugs.

In FDA's final guidance - issued last week - the agency lays out a road map for animal pharmaceutical companies to voluntarily revise the FDA-approved use conditions on the labels of these products to remove production indications.

The news that certain antimicrobial drugs are to be phased out as growth promoters in livestock means producers now have a time-frame to adjust production practices, commented professor of clinical sciences in K-State's College of Veterinary Medicine, Mike Apley.

He estimates that, for pigs, the new rule will remove about 16 per cent of the use of medically important antibiotics in feed for growing pigs. Cattle production will be less affected than pigs because cattle growth promoters are typically ionophores, which are not considered medically important, according to Professor Apley.

He added: "This news means the clock is ticking. Livestock producers and pharmaceutical companies have three months and three years to get it done," he said, referring to a three-month comment period which will be followed by a three-year period for drug companies to voluntarily revise FDA-approved labelled use conditions.

Professor Apley stressed that among the major implications of the new rule are that it removes the uses for improving performance and shifts oversight of the remaining uses to veterinarians.

In their 'Hog Outlook', market analysts, Ron Plain and Scott Brown, highlight that the new policy is likely to affect adversely decrease livestock and poultry feed conversion and thus increase feed demand. It would also drive up per-head veterinary costs, they add, especially for smaller operations.

Representing the poultry industry, the US National Chicken Council said in a statement: “We strongly support the responsible and judicious use of FDA-approved antibiotics and the involvement of veterinarians in raising healthy chickens.

“Antibiotics are not always used in raising chickens; rather, they are administered only when needed and on those occasions, they are used judiciously under the care of a veterinarian. For those antibiotics that are FDA-approved for use in raising chickens, the majority of them are not used in human medicine and therefore do not represent any threat of creating resistance in humans.

“That being said, we realise that there are strong emotions and conflicting views on the issue of antibiotic resistance – an issue that is very complex, and not black and white."

Animal health company, Zoetis, has announced that it supports the FDA’s efforts to voluntarily phase-out growth promotion indications for medically important antibiotics in food-producing animals. Zoetis has already taken action with the view to implementing Guidances #209 and #213 and has already taken action.

Professor Apley stated that Elanco has also already indicated it will comply with the guidelines.

Responding to the news that the rules are voluntary, long-time opponent of the use of antibiotics in farm animals, Congresswoman Louise Slaughter commented: “The FDA’s voluntary guidance is an inadequate response to the overuse of antibiotics on the farm with no mechanism for enforcement and no metric for success.

“Sadly, this guidance is the biggest step the FDA has taken in a generation to combat the overuse of antibiotics in corporate agriculture, and it falls woefully short of what is needed to address a public health crisis,” she added.

Jackie Linden