How FDA Would Alter Use Of Antibiotics In Food Animals

January 3, 2014Articles Law360

"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."

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.


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."