FDA's Strategy on Antimicrobial Resistance - Questions and Answers

1. What is FDA doing?

The Food and Drug Administration (FDA) is implementing a voluntary strategy to promote the judicious use in food-producing animals of antibiotics that are important in treating humans. The goal of the strategy is to protect public health and help curb the development of antimicrobial resistance and in turn help to reduce the number of infections in humans that are difficult to treat because existing antibiotics have become ineffective.

2. What are antimicrobial drugs and antimicrobial resistance?

“Antimicrobial drugs” include all drugs that work against a variety of microorganisms, such as bacteria, viruses, fungi, and parasites. “Antimicrobial resistance” is when bacteria or other microbes become resistant to the effects of a drug after being exposed to them. This means that the drug, and similar drugs, will no longer work against those bacteria. If resistant bacteria enter the food supply, drugs normally used to treat people infected with those bacteria may not work.

3. Why is FDA taking this action?

It is well established scientifically that all uses of antimicrobial drugs, in both humans and animals, contribute to the development of antimicrobial resistance, and that this is an important public health concern. Experts agree that antimicrobial drugs must be used “judiciously” in both animal and human medicine to slow the development of resistance.

4. What is “judicious use” and what are FDA’s recommendations?

“Judicious use” is using an antimicrobial drug appropriately and only when necessary; Based on a thorough review of the available scientific information, FDA recommends that use of medically important antimicrobial drugs in food-producing animals be limited to situations where the use of these drugs is necessary for ensuring animal health, and their use includes veterinary oversight or consultation. FDA believes that using medically important antimicrobial drugs to increase production in food-producing animals is not a judicious use.

5. Why did FDA decide to do this now?

FDA has worked with many stakeholder groups and the U.S. Department of Agriculture (USDA) to develop a strategy that will be successful in reducing antimicrobial resistance while minimizing adverse impacts on animal health and disruption to the animal agricultural industry. In June 2010, FDA released a draft guidance document explaining its recommendations for change and in the interim period sought and received input from various stakeholders, including the animal pharmaceutical industry, animal feed industry, veterinary and animal producer communities, consumer advocacy groups and USDA. Today's announcement is the culmination of this effort to develop a workable path forward.

6. What specific steps is FDA taking?

FDA is taking a three-pronged approach:

• First, it is issuing an updated, final version of guidance for industry, The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals (Guidance #209). The guidance establishes the framework for phasing out production uses of antimicrobials that are important in treating humans and phasing in veterinary consultation or oversight of the remaining therapeutic uses of such drugs. The purpose of this guidance is to: (1) Discuss FDA’s public health concerns about how certain uses of medically-important antimicrobial drugs in food-producing animals may impact antimicrobial resistance; (2) Summarize some of the key reports and scientific literature on the use of antimicrobial drugs in animal agriculture; and (3) Outline FDA’s recommendations on how to make sure that medically-important antimicrobial drugs are used judiciously in food-producing animals and remain effective for animals and people.
• Second, FDA is issuing for public comment draft guidance (Guidance #213) that will guide drug companies seeking to voluntarily revise product labels to (a) remove the use of antibiotics for production uses such as feed efficiency and growth promotion from their FDA-approved product labels; (b) adding, where appropriate, scientifically-supported disease prevention, control, and treatment uses and (c) changing the marketing status to include veterinary oversight or consultation. FDA is inviting comment on this draft.
• Third, the agency is inviting comment on the Veterinary Feed Directive (VFD) regulation that governs veterinary authorization of the use of certain drugs in animal feed. VFD drugs are animal drugs intended for use in or on animal feed which are limited to use under the professional supervision of a licensed veterinarian. Changes are needed to modernize and streamline VFD procedures in order to facilitate phasing in greater veterinary oversight of the use of antibiotics in animal feeds in a manner that is both practically feasible and efficient.

7. Which antimicrobial drugs used in food-producing animals are the focus of FDA’s strategy?

The voluntary strategy is primarily focused on medically important antimicrobial drugs that:

• Were approved prior to the issuance of Guidance 152, Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern, was published in October 2003.
• Are used in food-producing animals to increase feed efficiency and promote growth;
• Are available over-the-counter (OTC), and therefore, can be given without a veterinarian’s involvement; and
• Are given continuously through the feed or water to entire herds or flocks of animals.

A list of antimicrobial drugs FDA considers medically-important can be found in Appendix A of Guidance for Industry #152.

8. How have antimicrobial drugs traditionally been used in food-producing animals?

Antimicrobial drugs that are FDA-approved for use in food-producing animals are normally used to:

• Treat or control an on-going infectious disease;
• Prevent an infectious disease before an outbreak occurs; or
• Increase production by making the animal gain weight faster and by improving the animal’s ability to convert the food it eats (improved feed efficiency). With these agricultural production uses, typically no disease is present and no outbreak is anticipated to occur. These drugs are given to animals to enhance the production of animal-derived food products.

9. Why is the involvement of a veterinarian important?

Most of the antimicrobial drugs approved for use in food-producing animals in feed or water are over-the-counter products. Including veterinary oversight or consultation when these drugs are used in food-producing animals is an important way to ensure judicious use. This is because judicious use involves accurately identifying bacterial disease that is present or likely to be present and selecting the suitable antimicrobial drug. In the case of prevention, judicious use includes a consideration of relevant factors for determining the risk of a specific bacterial disease. FDA understands that veterinary oversight or consultation varies due to many factors, such as geographic location of the farm and different animal production methods. Sometimes, veterinarians directly diagnose and treat animals, while other times, they periodically visit and consult with an animal producer to customize a disease management protocol for that producer’s herd or flock.

10. How will greater veterinary oversight help ensure that the use of medically important antimicrobial drugs for disease prevention purposes is appropriate and judicious? Can you give an example?

We believe that veterinary expertise can determine whether the use of antimicrobials for preventive purposes is appropriate in a particular situation and, thus, would be considered judicious. We also believe that veterinarians are uniquely qualified to determine which specific diseases or conditions are likely to be present and to determine which specific approved drug or combination drug is most appropriate, based on factors such as the mode of antibacterial action, drug distribution in specific tissues, and the duration of effective drug levels at the site of infection. From FDA’s standpoint, the administration of antimicrobial drugs to animals when a veterinarian determines that there is a risk of a specific disease based on the presence of risk factors such as the stress of transport, environmental factors, or weaning, would be considered judicious use for prevention. For example, if a veterinarian determines, based on the client’s production practices and history, that a group of weaned beef calves arriving at a feedlot in bad weather after a lengthy transport is likely to develop an infection, preventively treating this group with an antimicrobial approved for prevention of that bacterial infection would be considered a judicious use. On the other hand, FDA would not consider administration of a drug to apparently healthy animals in the absence of any information that such animals were at risk of a specific disease to be a judicious use for prevention.

11. How will FDA implement the recommendations for judicious use?

FDA wants the recommendations to be implemented in a way that protects the health of animals and people. FDA does not want the recommendations to negatively impact animal health or disrupt the animal agriculture industry. FDA recognizes the need to collaborate with the animal health and animal producer communities on strategies for minimizing animal health impacts or industry disruption that may be associated with the implementation of changes by animal drug sponsors to voluntarily align the use conditions of affected drug products with the principles outlined in guidance #209.

12. When will FDA implement these recommendations?

Upon issuance of the final version of guidance #213, FDA intends to monitor the progress of its strategy for the voluntary adoption of the changes outlined, including the progress of measures intended to facilitate an orderly and minimally disruptive transition. After 3 years, FDA intends to evaluate the rate of voluntary adoption of the proposed changes across affected products. The agency will consider further action as warranted in accordance with existing provisions of the FD&C Act for addressing matters related to the safety of approved new animal drugs.