Antibiotic Use in Food Animals: FDA’s Current Activities

Antibiotic Use in Food Animals: FDA’s Current Activities

March 28, 2014
Antibiotic Use in Food Animals: FDA’s Current Activities
Issue
present in a part of a flock or herd. Lastly, low doses of
The U.S. Food and Drug Administration (FDA), which
antibiotics may be fed to animals over a longer period of
evaluates human and animal drugs for safety and
time to increase growth rates or improve feed efficiency.
effectiveness, is concerned that public health may be at risk
from certain antibiotic uses in food animals. According to
Currently, antibiotics may be dispensed to food animals in
FDA, foods of animal origin may be contaminated with
several ways. Some types may be purchased over-the-
pathogens that cause certain types of foodborne infections,
counter (OTC) and used by producers. Antibiotics added to
and antibiotic use in animals that produce these foods may
feed must be accompanied by a veterinary feed directive
render the infections less amenable to treatment, due to
(VFD), a special type of veterinary prescription for this
antibiotic resistance.
purpose. Veterinarians may prescribe antibiotics used
through other routes, such as injection. Although
In response, FDA has issued two guidance documents for
veterinarians may prescribe most drugs “extra-label” (using
industry that define judicious use of antibiotics, ask animal
a drug for a species or indication other than those on the
drug companies voluntarily to stop labeling antibiotics for
label), restrictions already exist on extra-label use of
production uses, and call for more veterinary oversight.
antibiotics in food animals. Finally, certain types of drugs,
including some types of antibiotics, are prohibited for use in
FDA says a voluntary approach is the fastest and most
food animals under any circumstances.
efficient way to tighten control over the use of medically
important antibiotics. Regulatory action may require FDA
FDA’s Efforts to Limit Animal Antibiotic
to conduct product-by-product evaluations that could
Use
require more time and resources.
The FDA Center for Veterinary Medicine (CVM) oversees
the agency’s efforts to assure the safety and effectiveness of
Some stakeholders, mainly led by consumer groups, say
animal drugs, as required under Section 512 of the Federal
that use of antibiotics in food animals leads inevitably to
Food, Drug, and Cosmetic Act (FFDCA, 21 U.S.C. 360b).
drug resistance in foodborne pathogens, and that such use
CVM issues guidance documents for industry which
should be curtailed. Other stakeholders, mainly led by
provide FDA’s current thinking on issues. Guidance
industry groups, say that untreatable human infections due
documents do not necessarily establish legally enforceable
to resistance result from misuse of antibiotics in the
responsibilities, but provide recommendations for the
healthcare system. FDA asserts that concerns about
industry.
antibiotic-resistant human infections resulting from
antibiotic use in food animals are well documented, and
At a July 2009 hearing before the House Committee on
FDA generally possesses broad authority to regulate these
Rules, the Obama Administration signaled that it would
drugs based on this public health effect.
address the use of antibiotics in food-producing animals.
For the first time, an FDA official stated that the use of
antimicrobials for growth promotion or feed efficiency was
not a judicious use.
An antimicrobial is a drug that acts against many
pathogens, including bacteria, viruses, fungi, or
In June 2010, FDA released the draft Guidance for Industry
parasites. An antibiotic is an antimicrobial drug that
#209 (GFI #209), The Judicious Use of Medically
acts against bacteria. Most drugs of concern in this
Important Antimicrobial Drugs in Food-Producing
discussion are antibiotics. FDA uses the broader term
Animals. The final version of GFI #209 was released April
antimicrobial in its publications.
2012. In GFI #209, FDA states that a proactive approach is

necessary to reduce antibiotic resistance and preserve the
effectiveness of medically important antibiotics for humans
Antibiotic Use in Food Animals
and animals. FDA offers two principles for the use of
FDA has approved three uses (called label indications) of
antimicrobials.
antibiotics in food animals: treatment of disease, prevention
or control of disease, and growth enhancement. First,
(1) The use of medically important antimicrobial drugs in
livestock and poultry producers use antibiotics to treat sick
food-producing animals should be limited to those uses that
animals, usually at a high dose for a short period of time.
are considered necessary for assuring animal health.
Second, antibiotics may be used, sometimes at a reduced
(2) The use of medically important antimicrobial drugs in
dosage, to prevent disease during times when animals may
food-producing animals should be limited to those uses that
be more susceptible to infections (for example, after
include veterinary oversight or consultation.
weaning or during transport) or control disease when
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Antibiotic Use in Food Animals: FDA’s Current Activities
First, FDA defines certain uses (indications) as “production
its VFD regulations so that they are consistent with the
uses,” that is, uses intended to hasten growth or improve
proposals in GFIs #209 and #213 (78 Fed. Reg. 75515).
feed efficiency in animals, rather than to treat or prevent
specific diseases. FDA states that production uses are not
Stakeholder Reaction
judicious, that they contribute to public health problems
Reaction to GFI #213 has been mixed. Trade groups that
through the development of antibiotic resistance, and that
represent animal drug companies, (e.g., Animal Health
they should be phased out. In addition, FDA states that the
Institute, Generic Animal Drug Alliance) and livestock and
use of medically important antibiotics for preventive use is
poultry industry groups (e.g., American Meat Institute,
judicious as long as veterinarians are involved in the
National Chicken Council) have expressed support for GFI
decision-making process.
#213 for its collaborative approach to judicious use. Other
stakeholder groups (e.g., Natural Resources Defense
Council, Keep Antibiotics Working) are skeptical of FDA’s
voluntary approach, fearing that industry will simply switch
According to FDA’s Center for Veterinary Medicine,
from production to preventive indications, resulting in little
halting production uses of antimicrobials “promotes
to no reduction in antibiotic use in food animals.
the judicious use of important antimicrobials, which
protects public health and, at the same time, ensures
Some Members of Congress have also publicly expressed
that sick and at-risk animals receive the therapy they
concern that GFI #213 is an inadequate response that lacks
need.”
enforcement mechanisms, or that it does not guarantee the

prudent use of antibiotics for preventive indications.
Second, FDA states that judicious uses of antibiotics in
Legislation introduced in the 113th and previous
food animals (i.e., for disease treatment or prevention)
Congresses, the Preservation of Antibiotics for Medical
should fall under veterinary supervision. Currently, many
Treatment Act of 2013 (H.R. 1150), along with a Senate
antibiotics are approved for OTC use in food animals. FDA
companion bill (S. 1256), would limit the use of medically
believes OTC use should be discontinued.
important antibiotics to treatment in food animals, restrict
prevention use, and prohibit production use. The legislation
FDA notes that it considers the antibiotics listed in its 2003
would essentially make mandatory what FDA guidance
Guidance for Industry #152, Evaluating the Safety of
documents are intended to accomplish.
Antimicrobial New Animal Drugs with Regard to Their
Other FDA Actions
Microbiological Effects on Bacteria of Human Health
Concern, as medically important to human health.
In 2009, FDA began to report sales and distribution data on
antimicrobials approved for use in food animals as required
Subsequently, FDA provided a roadmap for animal drug
by the Animal Drug User Fee Amendments of 2008
sponsors (companies) to follow to abide by the principles in
(ADUFA), which amended the FFDCA. FDA reports for
GFI #209. In December 2013, FDA issued Guidance for
2009-2011 include volume sold and distributed by
Industry #213 (GFI #213), New Animal Drugs and New
antimicrobial class and a breakdown by class of the active
Animal Drug Combination Products Administered in or on
ingredients. In a July 2012 advance notice of proposed
Medicated Feed or Drinking Water of Food-Producing
rulemaking, FDA requested comments on its antimicrobial
Animals: Recommendations for Drug Sponsors for
sales and distribution reporting. Comments indicated a
Voluntarily Aligning Product Use Conditions with GFI
desire for more drug usage information in order to provide
#209. In GFI #213, FDA asks drug sponsors to work
stakeholders with a better understanding of antimicrobial
voluntarily with the agency to review existing approvals of
resistance. In September 2013, FDA issued a notice with a
antibiotics used in food animals, and to update the evidence
request for comment on four additional tables that could be
for a treatment or preventive use or consider withdrawing
included in its annual ADUFA reports. Future reporting
the drug. FDA also asked drug sponsors to advise them,
could include antibiotics listed according to medical
within 90 days of the publication of GFI #213, whether they
importance, and then by antibiotic class; by method of
planned to participate. FDA reported in March 2014 that all
administration (feed, water, injection, other); by indication
but one animal drug sponsor affected by GFI #213 have
(therapeutic, both treatment and prevention, and
agreed to pursue the goals of the guidance.
production); and lastly, by dispensing method (OTC, VFD,
Rx). Potentially, more robust reporting could address some
stakeholder concerns about how well FDA’s guidance is
FDA plans to reassess, in three years, whether this
voluntary approach achieves FDA’s goal, namely, that all
implemented over the three-year phase-in period.
approved antibiotics used in food animals have at least one
evidence-based treatment or preventive use (indication) in
For FDA information on judicious use of antimicrobials,
at least one species of food animal, and that all such uses
see http://www.fda.gov/AnimalVeterinary/SafetyHealth/
involve either traditional veterinary prescription or a
AntimicrobialResistance/JudiciousUseofAntimicrobials/def
veterinary feed directive (VFD).
ault.htm.
In addition to laying out FDA’s approach, GFI #213
Joel L. Greene, Analyst in Agricultural Policy
provides information about the nature of evidence drug
Sarah A. Lister, Specialist in Public Health and
sponsors may use to support a treatment or preventive
Epidemiology
indication. Also, FDA has published a proposed revision to
IF10190
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Antibiotic Use in Food Animals: FDA’s Current Activities

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https://crsreports.congress.gov | IF10190 · VERSION 4 · NEW