Mixed reactions on FDA antibiotic guidance

The agency invites comments on the draft guidance, available online and titled The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals.

 

In a first reaction Joel G. Newman, president and CEO, American Feed Industry Association, said: “AFIA is thoroughly reviewing the FDA/CVM publication and will provide comments. We look forward to continuing our discussions with FDA and participating in an objective, science-based process as the agency continues its efforts.”

 

The US National Pork Producers Council (NPPC) has responded critically to the announcement of the FDA.

 

 “This guidance could eliminate certain antibiotics that are extremely important to the health of animals,” said NPPC president Sam Carney.

 

“FDA didn’t present any science on which to base this, yet it could have a tremendous negative impact on animal health and, ultimately, the safety of food. As we know, healthy animals produce safe food, and we need every available tool to protect animal health."

 

The draft guidance outlines the FDA’s current thinking on strategies to assure that antimicrobial drugs that are important for therapeutic use in humans are used judiciously in animal agriculture.

 

The FDA acknowledges the efforts to date by various veterinary and animal producer organisations to institute guidelines in the desired direction, but the agency believes additional steps are needed.

 

The draft guidance summarises a number of published reports on antimicrobial resistance. It states that with current knowledge and evidence the conclusion that using medically important antimicrobial drugs for production or as a growth promoter in livestock is not in the interest of protecting and promoting the public health.

 

The document recommends phasing in measures that would limit the use of medically important antimicrobial drugs in food-producing animals that are considered necessary for assuring animal health. A veterinarian should have the final decision for use.

 

These steps would help reduce overall use of medically important antimicrobial drugs, thereby reducing the pressure that generates antimicrobial resistance.

 

The FDA recognises the importance of antimicrobial drugs for addressing the health needs of animals.

 

Antimicrobial drugs have been widely used in human and veterinary medicine for more than 50 years with benefits to both human and animal health.

 

The development of resistance to these drugs, and the resulting loss of their effectiveness, poses a serious public health threat, it states.

 

“Using medically important antimicrobial drugs as judiciously as possible is key to minimising resistance development and preserving the effectiveness of these drugs as therapies for humans and animals,” said Dr Bernadette Dunham, director of the FDA’s Center for Veterinary Medicine.