FDA Antibiotic Regulation Through the Decades

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For more than 50 years, veterinarians and producers have administered antibiotics to food animals, primarily poultry, swine, and cattle, mostly to fight or prevent animal diseases. The FDA has provided a tightly regulated framework on how antibiotics can be used in the food supply.

  • 1980’s – All new medically important antibiotics have been approved with veterinary oversight.
  • 1996 – National Antimicrobial Resistance Monitoring System (NARMS) established.
  • 1997 – Extralabel use of fluoroquinolones and glycopeptides prohibited
  • 2003 – FDA established industry guidance for assessing antimicrobial resistance risks as part of the drug approval process
  • 2005 – Withdrawal of approval of fluoroquinolones for use in poultry
  • 2005 – Approach to evaluate the effect of antimicrobial residues on human intestinal flora into the pre-approval safety procedure enacted
  • 2010 – Initiated The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals
  • 2010 – First publication of annual summary report of antimicrobials sold for use in food-producing animals 
  • 2012 – Prohibited certain extralabel uses of cephalosporins 
  • 2012 – published final Guidance for Industry #209, draft Guidance for Industry #213,  and draft Veterinary Feed Directive proposed rule
    • Guidance for Industry #209 outlines the procedure for phasing out antibiotic use for growth promotion and phasing in veterinary oversight of these antibiotics.
  • 2012 & 2013 – Solicited public input on data collection and reporting related to antimicrobial use in food-producing animals.
  • 2013 – Published final Guidance for Industry #213 and proposed Veterinary Feed Directive rule.
  • 2013 – FDA revised its animal sampling structure in the National Antimicrobial Resistance Monitoring System (NARMS) to get more representative animal data on all four target organisms under surveillance.
    • NARMS partners at CDC and USDA have published over 150 peer-reviewed research articles examining the nature and magnitude of antimicrobial resistance hazards associated with antibiotic use in food producing animals
  • 2013 – FDA partnered with three State public health laboratories to collect more data on resistance in bacteria from retail meats.
  • 2014 – FDA is working with USDA and CDC to explore mechanisms for gathering representative antibiotic use information for food producing animals.
  • 2014 – First publication of annual summary report of antimicrobials sold for use in food-producing animals in expanded format
  • 2015 – FDA issued the Veterinary Feed Directive final rule
    • This rule lays out what veterinarians must do when they need to authorize the use of antimicrobials in feed to protect the animals they serve.
  • 2016 – Implementation of Gudiance for Industry #213 is anticipated to be completed.