FDA outlines steps to curb US antibiotic use

Beef Central, 12/04/2012

The US Food and Drug Administration announced yesterday that it is taking three steps to protect public health and promote the judicious use of medically important antibiotics in food-producing animals.

The move follows a March 22 decision by the US District Court to order the FDA to initiate proceedings to withdraw approval for certain antibiotics in livestock for the purposes of growth promotion and feed efficiency.

The US agency yesterday issued a statement to explain new steps it is taking with animal, drug and medical communities in the US to promote judicious antimicrobial use.

Antimicrobial resistance occurs when bacteria or other microbes develop the ability to resist the effects of a drug. Once this occurs, a drug may no longer be as effective in treating various illnesses or infections. Because it is well established that all uses of antimicrobial drugs, in both humans and animals, contribute to the development of antimicrobial resistance, it is important to use these drugs only when medically necessary, the agency said.

The FDA said it has a voluntary initiative in the US to phase in certain changes to how medically important antimicrobial drugs are labelled and used in food-producing animals.

Under the initiative, certain antibiotics would not be used for so-called “production” purposes, such as to enhance growth or improve feed efficiency in an animal. These antibiotics would still be available to prevent, control or treat illnesses in food-producing animals under the supervision of a veterinarian.

The FDA has published three documents that outline the steps:

  • A final guidance for industry, The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals, that recommends phasing out the agricultural production use of medically important drugs and phasing in veterinary oversight of therapeutic uses of these drugs.
  • A draft guidance, open for public comment, which will assist drug companies in voluntarily removing production uses of antibiotics from their FDA-approved product labels; adding, where appropriate, scientifically-supported disease prevention, control, and treatment uses; and changing the marketing status to include veterinary oversight.
  • A draft proposed Veterinary Feed Directive regulation, open for public comment, that outlines ways that veterinarians can authorize the use of certain animal drugs in feed, which is important to make the needed veterinary oversight feasible and efficient.

“It is critical that we take action to protect public health,” FDA Commissioner Margaret A. Hamburg said.

“The new strategy will ensure farmers and veterinarians can care for animals while ensuring the medicines people need remain safe and effective. We are also reaching out to animal producers who operate on a smaller scale or in remote locations to help ensure the drugs they need to protect the health of their animals are still available.”

“USDA worked with the FDA to ensure that the voices of livestock producers across the country were taken into account,” Dr John Clifford, USDA Chief Veterinary Medical Officer, said.

“And we will continue to collaborate with the FDA, the American Veterinary Medical Association and livestock groups to ensure that the appropriate services are available to help make this transition.”

Australian position on anti-microbial use in livestock production

Meanwhile, the Australian Animal Health Alliance has provided the following statement on the Australian situation and the alliance’s position on the use of antibacterial agents:

Australian situation

"There have been no products containing penicillin, tetracycline, oxytetracycline or chlortetracyline approved for use as growth promotants in livestock for more than 30 years. The tetracyclines remain in use as valuable prescription only veterinary medicines for addition to livestock feed for the treatment or prevention of disease. However, there are no penicillin products used in livestock feed for any purpose.

At the 83rd session of the National Health and Medical Research Council (Hobart, April 1977) the NHMRC recommended that penicillins and tetracyclines (and in addition, aminoglycosides, cephalosporins, chloramphenicol, sulphonamides and trimethoprim) not be approved as growth promotants in animal husbandry. In addition the NHMRC recommended that the States and Territories adopt the recommendation that penicillin and tetracycline be placed in Schedule 4 where preparations containing these antibiotics would only be available under veterinary prescription for therapeutic and prophylactic use. This recommendation was progressively adopted throughout Australia by 1982."

Alliance position

"The Animal Health Alliance (Australia) Ltd (the Alliance) recognises antibacterial agents as invaluable tools for judicious use in carefully planned herd and flock health programmes.

The Alliance has been a strong advocate of science based decision making by regulators and has supported the application of antimicrobial resistance risk assessment methodology in the determination of applications for new antimicrobial products. The value of risk analysis has been emphasised in the Report of the Joint Expert Technical Advisory Committee on Antimicrobial Resistance (JETACAR) in 1999 (recommendation 4) and a systematic approach is described by the Australian Pesticides and Veterinary Medicines Authority (APVMA) in Part 10 of their guidelines. The Alliance has supported and continues to support recommendation 6 of the JETACAR report “that all antibiotics for use in humans and animals (including fish) be classified as S4 (prescription only)”. The Alliance additionally supports the APVMA Chemical Review programme by which any approved products can be re-assessed if new evidence finds that their use may be unsafe.

Rigorous evidence based regulatory review combined with judicious use ensures that antimicrobial agents are administered safely and effectively in the maintenance of the health and welfare of Australian livestock."



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