Cut Down Influenza A with Sequivity(R) IAV-S NA

FDA Publishes Guidance to Limit Production Uses of Antimicrobials

The U.S. Food and Drug Administration is taking three steps to alter the use of medically important antibiotics in food-producing animals. Citing agency concerns regarding the development of antimicrobial resistance in humans resulting from the production use of antimicrobials, FDA is proposing a voluntary initiative to phase in certain changes to how medically important antimicrobial drugs are labeled and used in food-producing animals. The intent of this action is to help preserve the effectiveness of medically important antimicrobials for treating disease in humans.

According to an FDA news release, the agency is issuing three documents guiding veterinarians, farmers and animal producers on the judicious use of medically important antibiotics in food-producing animals by targeting their use to only address diseases and health problems. Under this new voluntary 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. There will be a 3 year “phase-in” period before these changes will become effective. It was unclear exactly when this phase-in period would begin.

In response to questions during a recent conference call, the agency noted that antimicrobial resistance monitoring surveys such as NARMS could provide an indication of the effectiveness of these proposed changes over time. FDA acknowledged, however, that the multi-year ban on the use of fluoroquinolones in poultry has not resulted in a measureable decrease in Campylobacter resistance in humans.

The FDA has published the following three documents in the Federal Register:

  • A final guidance for industry (Guidance #209), 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  • A draft guidance (Draft Guidance #213), open for public comment, which will assist drug companies in voluntarily removing production uses of antibiotics from their FDA-approved product labels;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.

FDA is currently accepting comments on Draft Guidance #213 and on the VFD document. Submit comments on these documents by the date provided in the Federal Register notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. You should identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic. It should be noted, however, that FDA intends to work with drug manufacturers to remove label indications for growth promotion and feed efficiency from products considered important for human health. Once these products are no longer labeled for production uses, it will be illegal for veterinarians or producers to utilize medicated feeds for these purposes.