FDA Issues Draft Guidance on 'Judicious Use' of Antimicrobials in Food-Producing Animals (7/1/10)

The Food and Drug Administration (FDA) on June 28 issued and sought comments on a significant draft guidance document that outlines a framework that the agency intends to use to reduce the development of human resistance to "medically important" antimicrobial drugs used in food-producing animals.  

The draft guidance outlines the agency’s current thinking on strategies to ensure that antimicrobial drugs important for therapeutic use in humans are used "judiciously" in animal agriculture production.  In issuing the guidance, FDA acknowledged the efforts by various veterinary and animal producer organizations to institute guidelines for the judicious use of antimicrobial drugs, but stated that it believes additional steps are needed.

The availability of the draft guidance was announced by FDA during a June 28 stakeholder teleconference that included presentations by FDA Principal Deputy Commissioner Joshua Sharfstein and Bernadette Dunham, director of FDA's Center for Veterinary Medicine.  During opening remarks, Sharfstein said that the "misuse and overuse (of animal drugs) contributes to rapid development of resistance among many bacteria," and that "it is essential that such drugs be used judiciously to delay the development of resistance."  Dunham added that "using medically important drugs as judiciously as possible is key to minimizing the development of resistance and preserving the effectiveness of such drugs as therapies for both humans and animals."

A large portion of the 19-page draft guidance summarizes research studies and reports on antimicrobial resistance published over the past 40 years.  Based upon its review of such information, FDA states that it believes "the overall weight of evidence available to date supports the conclusion that using medically important antimicrobial drugs for production or growth-enhancing purposes (i.e., non-therapeutic or subtherapeutic uses) in food-producing animals is not in the interest of protecting and promoting…public health."

To address its concern about antimicrobial resistance, FDA recommends the following two principles within the draft guidance regarding judicious use of medically important antimicrobial drugs in animals:

• The use of medically important antimicrobial drugs in food-producing animals should be limited to those uses considered necessary for animal health.  FDA states that it believes the use of medically important antimicrobial drugs in food-producing animals for production purposes (for example, to promote growth or improve feed efficiency) represent an injudicious use of such drugs.  The agency further states that production uses are not directed at any specifically identified disease, but rather are expressly indicated and used to enhance the production of animal-derived products.
  
  
• The use of medically important antimicrobial drugs in food-producing animals should be limited to those uses that include veterinary oversight or consultation.  In addition to instituting measures that would limit use of medically important antimicrobial drugs in food-producing animals to those applications considered necessary to ensure the animals’ health, FDA states that it believes it is important to phase-in the practice of including veterinary oversight or consultation in the use of such drugs.  In the draft guidance, FDA acknowledges that increasing veterinary involvement in the use of antimicrobial drugs has significant practical implications for animal producers, veterinary practitioners and the veterinary profession as whole.  FDA also states that it particularly is interested in receiving comments on strategies for effectively phasing-in such a change.

When announcing the draft guidance, FDA provided no timetable for when it potentially would develop new regulations to implement its recommended principles to minimize antimicrobial resistance.  Instead, during the stakeholder teleconference, Sharfstein said that the draft guidance "gets the ball rolling in (FDA's) assessment of what can be done" and that the agency "is very interested in getting comments from everybody about how these goals can be accomplished as quickly and as feasibly as possible."  Sharfstein also said that he believes that "there is the potential for steps to be taken without additional regulatory actions by the agency that companies could take, and that there are other options, such as regulatory options, that are possible."

On June 29, FDA published a Federal Register notice in which the agency provided a 60-day stakeholder comment period on the draft guidance, ending Aug. 30.  The NGFA's Feed Legislative and Regulatory Affairs Committee, chaired by Jarvis Haugeberg, general manager of DakotaLand Feeds LLC, Huron, S.D., will spearhead the development of the NGFA's comments on the draft guidance, with input from the Feed Manufacturing and Technology Committee, and Feed and Animal Agriculture Strategic Issues Committee.

You may access the FDA draft guidance by clicking here.  FDA also has made available a question-and-answer webpage on the draft guidance that may be accessed by clicking here.  In addition, a replay of the June 28 stakeholder teleconference is available until July 19 by dialing 800-666-8698.