The U.S. Food and Drug Administration published its long-awaited final guidance on the use of antibiotics in food animals on Dec. 11, 2013, (Guidance for Industry #213[1]), finalizing some of its earlier preliminary recommendations limiting the use of antibiotics in feed and water to antibiotics considered not medically important for human use;[2] prohibiting the use for growth promotion; and restricting access to antibiotics used in food animals to those prescribed by veterinarians for therapeutic uses. Therapeutic uses include the control, prevention and treatment of disease. Food animal veterinarians, food animal producers and drug and feed manufacturers will have to comply with the FDA's new restrictions on the use of certain antibiotics in food animals, although compliance is currently voluntary. Once the FDA finalizes proposed changes to the Veterinary Feed Directives rule, which governs the use of antibiotics in animal feed, these restrictions will be mandatory.
While the science behind the cause and effect of
antibiotic resistance remains mired in controversy, opponents on
both sides of this issue agree that the FDA's current
guidelines are not appropriate. Skeptics are concerned that
producers will continue to use low, non-therapeutic doses of
antibiotics, using loopholes in the FDA's guidelines.
Therefore, they think the guidelines are not restrictive enough. On
the other hand, some food animal producers believe the use of
antibiotics in food animals is already judicious, and the new rules
will not change much.
Veterinarians and drug manufacturers, through the American
Veterinary Medical Association ("AVMA")[3] and the Animal
Health Institute ("AHI")[4] respectively, have expressed
support for the FDA's guidelines, reaffirming their commitment
to the judicious use of antibiotics in animals. The FDA defends its
guidelines explaining that "[t]his action promotes the
judicious use of important antimicrobials, which protects public
health and, at the same time, ensures that sick and at-risk animals
receive the therapy they need ..."[5]
It is clear that veterinarians will now stand squarely at the
gateway between antibiotics and food animals, with increased
responsibility over all use in these animals. While veterinarians
have always balanced the joint responsibility of keeping their
patients healthy and preserving the public health, they will face
increased scrutiny by federal and state officials, and possible
disciplinary actions, as a result of these new rules.
FDA Guideline Requirements
The FDA guidelines prohibit the future use of antibiotics for
growth promotion, whether to improve feed efficiency or increase
weight gain. To achieve this goal, the FDA has asked pharmaceutical
manufacturers to voluntarily remove the labeled use of these drugs
for all uses other than for therapeutic treatment. Once removed,
producers will be unable to use antibiotics unless prescribed by a
veterinarian to treat or prevent disease. The required oversight by
veterinarians for the use of antibiotics for disease prevention or
treatment appears, in theory, to provide the type of oversight that
will ensure that antibiotic use is judicious.
What is the Debate About?
The use of antibiotics in food-producing animals, to prevent
and/or control disease, has been a subject of discussion between
the medical, veterinary and animal agricultural sectors, as well as
related national and international government entities for decades.
The underlying premise is that use of antibiotics in food-producing
animals leads to the resistance of bacteria in meat and poultry
consumed by humans, reducing the effectiveness of antibiotics used
to treat bacterial diarrhea and/or sepsis resulting from exposure
to contaminated and improperly prepared food. The legal debate
surrounding the use of antibiotics in livestock in the United
States is particularly complex because it involves: animal and
public health policy, which may not always be aligned; multiple
federal agency and state governance; and passionate advocates who
support animal agriculture and related industries, or who oppose
the use of animals for food.
The FDA, responsible for "protecting the public health by
assuring the safety, effectiveness, and security of human and
veterinary drugs ..."[6] enforces the Federal Food, Drug and
Cosmetic Act[7] ("FDCA"), which authorizes the FDA's
regulation of most foods[8] as well as feed, drugs and devices used
in pets, farm animals and other animals. The FDA approves
applications of new animal drugs for sale and regulates the
manufacture and distribution of antibiotics used in animals.
Antibiotics used in food-producing animals are either prescribed by
veterinarians using drugs approved as labeled, prescribed for
extra-label use or added to animal feed in FDA-licensed feed mills.
The FDA's new guidance proposes to eliminate FDA approval of
antibiotics for food animals unless prescribed by a veterinarian
for therapeutic uses.
The FDA has taken a number of steps to limit or prohibit the use of
certain antibiotics in animals, but its failure to prohibit
antibiotic use in food-producing animals has been criticized by
some public health advocates. After the Obama administration
identified a renewed effort to eliminate the use of some
antibiotics in food animals, the FDA took steps to begin the
implementation of this policy. In 2010, the FDA issued a draft
guidance entitled "The Judicious Use of Medically Important
Antimicrobial Drugs in Food-Producing Animals," describing
"the [a]gency's current thinking on [the] topic,"
which includes: "1) limiting medically important antimicrobial
drugs to uses in food-producing animals that are considered
necessary for assuring animal health; and 2) limiting such drugs to
uses in food-producing animals that include veterinary oversight or
consultation."[9]
The FDA's Guidance # 213 implements these policies, in part by
requiring veterinary oversight of use of antibiotics for disease
prevention or treatment. This measure falls squarely between the
concerns of public health activists who want all antibiotics
preserved for human use, and concerns in the veterinary and animal
industry sectors that limiting antibiotic use in animals will cause
unnecessary animal suffering.
Some do not believe the FDA's policies go far enough. For
example, Michael Taylor, a former FDA official, and Rep. Louise
Slaughter, D-N.Y., reportedly expressed concerns that the
guidelines would still permit low doses of antibiotics to be given
to food animals for the prevention of disease, and instead, want to
limit antibiotic use to only sick animals.[10] Many veterinarians,
the AVMA and FDA believe that limiting antibiotic use in that way
would result in unnecessary illness and death. When other
countries, like Denmark, have prohibited antibiotic use in food
animals, except for the treatment of clinically sick animals,
illness in food animals increased, therapeutic uses of antibiotics
increased and the anticipated effect ─ decreased antibiotic
resistance in humans ─ did not occur.
Veterinarians Enhanced Oversight
For veterinarians to be effective in protecting our food supply,
it is paramount they have the appropriate tools, including
antibiotics, for preventing, mitigating and treating disease.
Veterinarians, facing increased scrutiny, will have to comply with
existing state and federal regulations, as well as the new FDA
guidelines to avoid disciplinary actions that could result in the
suspension of their license to practice.
The FDA has retained veterinary access to antibiotics which are
used to treat bacterial diseases in food animals. These infectious
diseases are often highly contagious diseases and spread quickly
between co-located animals in herds and flocks. To withhold
treatment to animals in the face of known risk in an infected herd
would result in unnecessary suffering. Similarly, where herd or
flock health histories reveal repeated instances of bacterial
infection at certain phase in production, which cannot be altered,
treatment with antibiotics, as directed and prescribed by
veterinarians, can prevent unnecessary illness. These uses of
antibiotics for the prevention of disease are delineated in
Guidance # 213, with specific examples to help inform veterinarians
about when such use would be considered judicious and when it would
run afoul of the law. However, there are a limited number of
examples provided, and veterinarians will have to use their skill,
training and best judgment in many instances.
What remains unclear is how the declining number of food animal
veterinarians will be able to service food animal producers under
these new restrictions. Since antibiotics will only be available to
food animals through veterinary prescriptions, more regular
oversight of herds and flocks is expected. Also, based on data from
other countries enacting similar restrictions there will be an
increase in the number of animals requiring treatment, and
therefore an increased number of prescriptions.
What has not changed, are the federal and state laws that require a veterinarian to establish a valid veterinary-client-patient relationship ("VCPR") before writing a prescription for any medication. The FDA has issued warning letters to veterinarians who have not properly established a VCPR before writing prescriptions for antibiotics in food animals, which they found particularly egregious when the treatment resulted in volative antibiotic residues in food intended for human consumption.[11] Similarly, states have disciplined veterinarians who did not have adequate oversight of herds before prescribing medications.[12]
If, under the FDA's new guidelines, a veterinary prescription is required for all antibiotic treatment of herds and flocks, veterinarians will have to have adequate knowledge of the animals' health before writing those prescriptions. The frequency of actual herd visits with hands on examinations before prescriptions are written will have to be carefully considered. While there are some decisions that can be made from afar, herd and flock veterinary care have typically required the use of four of our five senses, something not yet available through video conferencing. Regions or states already underserved by food animal veterinarians will create the greatest challenge to veterinary practitioners.
To ensure the smooth transition that the FDA is committed to, veterinarians, producers and government officials should keep the following guidelines in mind:
- A veterinarian must have a valid VCPR before writing a prescription for any medication;
- A valid VCPR requires site visits and visual inspections of the herds and flocks under a veterinarians care, on a regular enough basis to ensure that the veterinarian has knowledge of the health status of those animals;
- A visual inspection of the animals may or may not be required before each prescription is provided-for example, results of diagnostic testing may provide a diagnosis which serves as the basis for prescribing antibiotics to at-risk animals, without an additional veterinary visit, but when in doubt, consult with FDA officials for guidance on a case-by-case basis;
- A valid VCPR generally requires the veterinarian to have a state veterinary license for each state in which their herds or flocks are located, although, occasionally, the state may permit veterinarians to practice as a consultant without a license-veterinarians should review each state's laws for the specific requirements;
- If veterinary services are increasingly in demand, and span multiple states, the state laws governing veterinary practice may have to evolve to permit non-licensed veterinarians access to herds and flocks for adequate oversight and treatment, at least until those veterinarians can be properly licensed. Alternatively or in addition, the FDA may develop special certifications for food animal veterinarians, similar to those employed by U.S. Department of Agriculture, to permit certified food animal veterinarians to provide these services across state lines.
Conclusion
Fortunately, the FDA guidelines permit continued access to antibiotics for the treatment of sick food animals to ensure that these animals receive proper care. Veterinarians should be extra-vigilant to ensure that they are complying with all relevant federal and state guidelines, so they do not run afoul of the law, while they are helping maintain the health of animals and the wholesomeness of our food supply.
"Reprinted with permission from the January 3 issue of Law360. (c) 2014 ALM Media Properties, LLC. Further duplication without permission is prohibited. All rights reserved."
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