The US Food and Drug Administration ("FDA") is attempting to reduce the amount of antimicrobials used on farms for food production, such as those used to improve feed efficiency or enhance growth, in an effort to address antimicrobial resistance issues in humans and animals. The agency is implementing a "plan to ensure judicious use of antibiotics in food animals."1 Certain antimicrobials have historically been used in the feed or drinking water of cattle, poultry, hogs, and other food animals for production purposes and not for medical reasons. Some of these antimicrobials are important drugs that are also used to treat human infection. As a result, there is some concern that this practice will increase the ability of bacteria and other microbes to resist the effects of the drug, which could render the drug less effective in treating various illnesses or infections. The agency explained that because antimicrobial drug use in both humans and animals can contribute to the development of antimicrobial resistance, it is important to use these drugs only when medically necessary. According to health advocates, antibiotic-resistant infections are responsible for approximately 23,000 human deaths each year in the US.
On December 12, the agency announced in the Federal Register the availability of a now-final Guidance for Industry # 213: New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with Guidance for Industry # 209. The purpose of the document is to provide information to sponsors of certain antimicrobial new animal drug products who are interested in revising conditions of use for those products consistent with the agency's Guidance for Industry # 209: The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals. It also sets timelines for stakeholders who wish to comply voluntarily with the guidance. Guidance # 213 was initially announced in April 2012, giving stakeholders three months to provide comments to the FDA. Several stakeholders submitted comments. According to the agency, those comments were considered as the agency finalized the guidance document.
In the Federal Register, the agency explained that it intends to work with impacted drug sponsors to assist them with the voluntary implementation of the principles set forth in the guidance document through modifications to the approved conditions of use of their new animal drug products. According to the agency, a voluntary approach is more effective to "achieve the common goal of more judicious use of medically important antimicrobials in animal agriculture."2 Michael Taylor, the agency's Deputy Commissioner for Foods and Veterinary Medicine, stated that "[w]e see this as a very big step forward in an effort to tackle the problem of antibiotic resistance…[w]e all realize the time has come to take this step and move beyond these growth promotion uses."3
The agency provides a road map for animal drug companies to revise the FDA-approved conditions of use on their labels to remove production indications. Additionally, the agency is calling for changing the current over-the-counter status to bring the remaining appropriate therapeutic uses under veterinary oversight. Once a drug manufacturer makes these changes, its antimicrobial drugs will no longer be able to be used for production purposes and their use to treat, control, or prevent disease in animals will require veterinary oversight.