Animal & Veterinary
Antimicrobial Drugs: Judicious Use Fights Resistance
By Dr. Melanie McLean, Senior Writer/Editor, Communications with contributions from Dr. William Flynn, Senior Advisor for Science Policy, and Dr. Diane Heinz, Director of the Policy & Regulations Staff, Office of the Center Director
Purpose of Draft Guidance
CVM issued the draft guidance to address antimicrobial resistance and promote judicious use. The focus is on medically important antimicrobial drugs that are important therapies for bacterial infections in people. The draft guidance:
- Discusses FDA’s public health concerns about how certain uses of medically important antimicrobial drugs in food-producing animals may impact antimicrobial resistance;
- Summarizes some of the key scientific reports on the use of antimicrobial drugs in animal agriculture; and
- Outlines FDA’s recommendations to ensure that medically important antimicrobial drugs are used judiciously in food-producing animals and remain effective for animals and people.
Implications of Antimicrobial Resistance
Antimicrobial drugs have been widely used in human and veterinary medicine for more than 50 years with great benefits to both people and animals. However, resistance to antimicrobial drugs and the resulting loss of effectiveness of these drugs are serious public health threats. Drug-resistant bacteria that enter the food supply in or on food products made from animals may add to antimicrobial resistance in people.
Uses of Antimicrobial Drugs in Food-Producing Animals
Antimicrobial drugs that are FDA-approved for food-producing animals are currently 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 (increased rate of weight gain) and by improving the animal’s ability to convert the food it eats into growth (improved feed efficiency). Typically, no disease is present and no outbreak is anticipated. Rather, these drugs are given to animals so they make food for people faster and more efficiently.
To read CVM’s draft guidance, please visit: http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/ GuidanceforIndustry/UCM216936.pdf.
To read the Questions and Answers on CVM’s draft guidance, please visit:
The comment period on the draft guidance ends August 30, 2010.
Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.