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

antibiotics may be fed to animals over a longer period of
The U.S. Food and Drug Administration (FDA), which
time to increase growth rates or improve feed efficiency.
evaluates human and animal drugs for safety and
effectiveness, is concerned that public health may be at risk
Currently, antibiotics may be dispensed to food animals in
from certain antibiotic uses in food animals. According to
several ways. Some types may be purchased over-the-
FDA, foods of animal origin may be contaminated with
counter (OTC) and used by producers. Antibiotics added to
pathogens that cause certain types of foodborne infections,
feed must be accompanied by a veterinary feed directive
and antibiotic use in animals that produce these foods may
(VFD), a special type of veterinary prescription for this
render the infections less amenable to treatment, due to
purpose. Veterinarians may prescribe antibiotics used
antibiotic resistance.
through other routes, such as injection. Although
veterinarians may prescribe most drugs “extra-label” (using
In response, FDA has issued two guidance documents for
a drug for a species or indication other than those on the
industry that define judicious use of antibiotics, ask animal
label), restrictions already exist on extra-label use of
drug companies voluntarily to stop labeling antibiotics for
antibiotics in food animals. Finally, certain types of drugs,
production uses, and call for more veterinary oversight.
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
Some stakeholders, mainly led by consumer groups, say
the agency’s efforts to assure the safety and effectiveness of
that use of antibiotics in food animals leads inevitably to
animal drugs, as required under Section 512 of the Federal
drug resistance in foodborne pathogens, and that such use
Food, Drug, and Cosmetic Act (FFDCA, 21 U.S.C. 360b).
should be curtailed. Other stakeholders, mainly led by
CVM issues guidance documents for industry which
industry groups, say that untreatable human infections due
provide FDA’s current thinking on issues. Guidance
to resistance result from misuse of antibiotics in the
documents do not necessarily establish legally enforceable
healthcare system. FDA asserts that concerns about
responsibilities, but provide recommendations for the
antibiotic-resistant human infections resulting from
industry.
antibiotic use in food animals are well documented, and
FDA generally possesses broad authority to regulate these
At a July 2009 hearing before the House Committee on
drugs based on this public health effect.
Rules, the Obama Administration signaled that it would
address the use of antibiotics in food-producing animals.
An antimicrobial is a drug that acts against many
For the first time, an FDA official stated that the use of
pathogens, including bacteria, viruses, fungi, or
antimicrobials for growth promotion or feed efficiency was
parasites. An antibiotic is an antimicrobial drug that
not a judicious use.
acts against bacteria. Most drugs of concern in this
In June 2010, FDA released the draft Guidance for Industry
discussion are antibiotics. FDA uses the broader term
#209 (GFI #209), The Judicious Use of Medically
antimicrobial in its publications.
Important Antimicrobial Drugs in Food-Producing
Animals. The final version of GFI #209 was released April
Antibiotic Use in Food Animals
2012. In GFI #209, FDA states that a proactive approach is
necessary to reduce antibiotic resistance and preserve the
FDA has approved three uses (called label indications) of
effectiveness of medically important antibiotics for humans
antibiotics in food animals: treatment of disease, prevention
and animals. FDA offers two principles for the use of
or control of disease, and growth enhancement. First,
antimicrobials.
livestock and poultry producers use antibiotics to treat sick
animals, usually at a high dose for a short period of time.
(1) The use of medically important antimicrobial drugs in
Second, antibiotics may be used, sometimes at a reduced
food-producing animals should be limited to those uses that
dosage, to prevent disease during times when animals may
are considered necessary for assuring animal health.
be more susceptible to infections (for example, after
(2) The use of medically important antimicrobial drugs in
weaning or during transport) or control disease when
food-producing animals should be limited to those uses that
present in a part of a flock or herd. Lastly, low doses of
include veterinary oversight or consultation.
www.crs.gov | 7-5700

Antibiotic Use in Food Animals: FDA’s Current Activities
First, FDA defines certain uses (indications) as “production
Stakeholder Reaction
uses,” that is, uses intended to hasten growth or improve
Reaction to GFI #213 has been mixed. Trade groups that
feed efficiency in animals, rather than to treat or prevent
represent animal drug companies, (e.g., Animal Health
specific diseases. FDA states that production uses are not
Institute, Generic Animal Drug Alliance) and livestock and
judicious, that they contribute to public health problems
poultry industry groups (e.g., American Meat Institute,
through the development of antibiotic resistance, and that
National Chicken Council) have expressed support for GFI
they should be phased out. In addition, FDA states that the
#213 for its collaborative approach to judicious use. Other
use of medically important antibiotics for preventive use is
stakeholder groups (e.g., Natural Resources Defense
judicious as long as veterinarians are involved in the
Council, Keep Antibiotics Working) are skeptical of FDA’s
decision-making process.
voluntary approach, fearing that industry will simply switch
from production to preventive indications, resulting in little
According to FDA’s Center for Veterinary Medicine,
to no reduction in antibiotic use in food animals.
halting production uses of antimicrobials “promotes
the judicious use of important antimicrobials, which
Some Members of Congress have also publicly expressed
protects public health and, at the same time, ensures
concern that GFI #213 is an inadequate response that lacks
that sick and at-risk animals receive the therapy they
enforcement mechanisms, or that it does not guarantee the
need.”
prudent use of antibiotics for preventive indications.
Legislation introduced in the 113th and previous
Congresses, the Preservation of Antibiotics for Medical
Second, FDA states that judicious uses of antibiotics in
Treatment Act of 2013 (H.R. 1150), along with a Senate
food animals (i.e., for disease treatment or prevention)
companion bill (S. 1256), would limit the use of medically
should fall under veterinary supervision. Currently, many
important antibiotics to treatment in food animals, restrict
antibiotics are approved for OTC use in food animals. FDA
prevention use, and prohibit production use. The legislation
believes OTC use should be discontinued.
would essentially make mandatory what FDA guidance
documents are intended to accomplish.
FDA notes that it considers the antibiotics listed in its 2003
Guidance for Industry #152, Evaluating the Safety of
Other FDA Actions
Antimicrobial New Animal Drugs with Regard to Their
Microbiological Effects on Bacteria of Human Health
In 2009, FDA began to report sales and distribution data on
Concern, as medically important to human health.
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
ingredients. In a July 2012 advance notice of proposed
Animal Drug Combination Products Administered in or on
rulemaking, FDA requested comments on its antimicrobial
Medicated Feed or Drinking Water of Food-Producing
sales and distribution reporting. Comments indicated a
Animals: Recommendations for Drug Sponsors for
desire for more drug usage information in order to provide
Voluntarily Aligning Product Use Conditions with GFI
stakeholders with a better understanding of antimicrobial
#209. In GFI #213, FDA asks drug sponsors to work
resistance. In September 2013, FDA issued a notice with a
voluntarily with the agency to review existing approvals of
request for comment on four additional tables that could be
antibiotics used in food animals, and to update the evidence
included in its annual ADUFA reports. Future reporting
for a treatment or preventive use or consider withdrawing
could include antibiotics listed according to medical
the drug. FDA also asked drug sponsors to advise them,
importance, and then by antibiotic class; by method of
within 90 days of the publication of GFI #213, whether they
administration (feed, water, injection, other); by indication
planned to participate. FDA reported in March 2014 that all
(therapeutic, both treatment and prevention, and
but one animal drug sponsor affected by GFI #213 have
production); and lastly, by dispensing method (OTC, VFD,
agreed to pursue the goals of the guidance.
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
implemented over the three-year phase-in period.
voluntary approach achieves FDA’s goal, namely, that all

approved antibiotics used in food animals have at least one
For FDA information on judicious use of antimicrobials,
evidence-based treatment or preventive use (indication) in
see http://www.fda.gov/AnimalVeterinary/SafetyHealth/
at least one species of food animal, and that all such uses
AntimicrobialResistance/JudiciousUseofAntimicrobials/
involve either traditional veterinary prescription or a
default.htm.
veterinary feed directive (VFD).

In addition to laying out FDA’s approach, GFI #213
Joel L. Greene, jgreene@crs.loc.gov, 7-9877
provides information about the nature of evidence drug
Sarah A. Lister, slister@crs.loc.gov, 7-7320
sponsors may use to support a treatment or preventive

indication. Also, FDA has published a proposed revision to
IF00017
its VFD regulations so that they are consistent with the
proposals in GFIs #209 and #213 (78 Fed. Reg. 75515).
www.crs.gov | 7-5700

Document Outline

Issue

Antibiotic Use in Food Animals

FDA’s Efforts to Limit Animal Antibiotic Use

Stakeholder Reaction

Other FDA Actions