Sample Letter – Guidance 213
July 12, 2012
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Re: Comment on Draft Guidance for Industry #213 (Docket No. FDA-2011-D-0889)
To Whom It May Concern:
I/We appreciate the opportunity to comment on this Draft Guidance for Industry #213 intended to
implement FDA’s Final Guidance 209, “The Judicious Use of Medically Important Antimicrobial Drugs
in Food-Producing Animals.” We applaud the FDA’s Final Guidance #209 which focuses on two tenets
intended to promote judicious use of antimicrobials: 1) withdrawal of the use of important
antimicrobials in food animals for promotion of growth and/or feed efficiency and 2) veterinary
oversight in the dispensing of antimicrobials- particularly in feed and water, where whole herds and
flocks are the recipients. The latter involves a shift from OTC (over-the-counter) dispensing of
antimicrobials to that of veterinary feed directive (VFD) status, where increased veterinary oversight is
required.
Guidance #209 together with Draft Guidance #213 and the draft text for the Veterinary Feed Directive
[Docket No. FDA-2010-N-0155] represent a significant shift in U.S. public health protection. The
Guidance begins to address the high risks that non-judicious use of antimicrobials in animals pose for
human health – in the form of increases in drug resistance and potential treatment failures. They are,
however, insufficient.
There are some weaknesses in the guidance documents, which should be addressed if the guidance is to
achieve the stated objectives:
 The guidance is voluntary.
Recommendation: Require industry to comply with the recommendations for product labeling;
Require veterinary oversight/obligatory prescriptions for all antimicrobials used for disease
control in food animals.1 2

FDA considers “treatment, control, and prevention of specific diseases to be
therapeutic uses” essential to animal health.
Recommendation: FDA withdraw approval of use of antibiotics for prevention purposes under Part
512(e) of the Federal Food, Drug and Cosmetic Act. Define clearly what is meant: prevention,
control & treatment. Use antibiotics only to treat disease in target animals. Where possible, use
alternative strategies for disease prevention and control: vaccines, use of probiotics, improved
animal hygiene, husbandry and management practices. Consider workable strategies to mitigate
“stress” factors which place animals at risk for disease.
WHO Recommendations, 2001, WHO Global Strategy for Containment of Antimicrobial Resistance, Use of Antimicrobials in Food
Producing Animals, p. 5
2 FAAIR Report, Clinical Infectious Diseases, The Need to Improve Antimicrobial Use in Agriculture, 2002:34 (Suppl 3)
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Sample Letter – Guidance 213
 FDA alludes to challenges of implementing the veterinary oversight system for small
producers in remote geographical areas, where there is a shortage of veterinarians.
Recommendation: Education and outreach of animal husbandry workers on disease prevention, and
judicious use of antibiotics via agricultural extension programs, and rotation service of public
health veterinarians. Ensure that veterinarians have access to appropriate prescribing literature
on individual drugs. Provide incentives for veterinary professional organizations and schools to
provide training.
 Methods of monitoring progress are not clearly described, except for the statement that the
adoption of changes will be evaluated in three years time.
Recommendation: Surveillance and data collection are foundations of any public health program.
Create a national integrated surveillance system to monitor antimicrobial resistance and usage in
animals and humans. FDA can look to European colleagues who are engaged in such an effort
across all EU member states.3 The veterinary feed directive specifies very clearly the general
requirements of the directive, as well as the responsibilities of a veterinarian. Integrated
mandatory reporting is necessary to monitor practitioner compliance and antimicrobial use in
specific animal species and herds/flocks.
Numerous scientific studies4 demonstrate that overuse and misuse of antibiotics in food animal
production contributes to the emergence of drug-resistant bacteria that can infect people. Withdrawal of
growth promoters is an important step in reducing antibiotic overuse and minimizing the public health
threat of untreatable human infections. Other interventions must be adopted in tandem –including
appropriate monitoring and infection prevention and control measures, if an overall reduction in
antimicrobial use is to be achieved. In the case of the Netherlands, the government –in response to high
levels of resistance in animals – issued a mandate to reduce antimicrobial use in food animals by 50%
over a three year period through defined daily doses and transparency in prescriptions.5 It is our hope
that we can learn from our colleagues and progress to the large-scale changes necessary to ensure health
for humans, animals, and the environment.
Sincerely,
Name, title
Institutional affiliation
Herman Goossens, Evolution of Monitoring Systems for Antimicrobial Resistance and Antimicrobial Use, APUA Roundtable on “The EU Ban
on the Use of Antibiotics for Growth Promotion in Agriculture: Review of Scientific Evidence and Implications for Public Health,
May 29, 2010, Paris, France
4 Bonnie M. Marshall and Stuart B. Levy, “Food Animals and Antimicrobials: Impacts on Human Health,” Clinical Microbiological
Reviews, 2011: 24(4)
5Carol Cogliani, Herman Goossens, and Christina Greko, Restricting Antimicrobial Use in Food Animals: Lessons from Europe, Microbe,
volume 6, Number 6, 2011
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