Issue Brief

New FDA Policies on Antibiotics Use in Food Animal Production

Surveys of the animal production industry by the U.S. Department of Agriculture demonstrate that many farms and ranches administer antibiotics to healthy animals at low doses to offset overcrowding and poor sanitation and to accelerate livestock growth—practices that the medical and public health communities document as a significant factor in human antibiotic resistance.

In fact, the U.S. Food and Drug Administration reported that in 2011, nearly 30 million pounds of antibiotics sold in the United States were for food animals, almost four times the amount sold for human use.1 FDA, USDA, and the Centers for Disease Control and Prevention have testified before Congress that there is a definitive link between the routine nontherapeutic use of antibiotics in food animal production and the crisis of antibiotic resistance in humans.2

In 2013, FDA took steps to address these concerns.

Policies encouraging judicious use of antibiotics

In December 2013, FDA issued two policy documents on the use of medically important antibiotics in food animal production—an important first step toward curbing the inappropriate use of antibiotics in this industry. Specifically, the agency issued:

  • Final industry guidance : “New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209; Guidance for Industry #213.”
  • Proposed rule : “Veterinary Feed Directive.”

These two policies were issued to establish the agency's position regarding judicious use of antimicrobials in food animals. However, the documents have deficiencies that need to be addressed to slow the growing public health crisis of antibiotic resistance. It is important to note that the guidances are voluntary, so companies are not required to follow them.

Final Guidance for Industry #209: What it does

  • Endorses key scientific studies establishing links between antibiotic-resistant infections in people and antibiotic use in food animals.
  • Determines that use of antibiotics for growth promotion is inappropriate, as are other uses solely for “production purposes.”
  • Determines that use of antibiotics for disease prevention and control (where disease can occur) may be judicious under certain conditions, such as when specific bacteria are targeted.
  • Calls for veterinary oversight of all antibiotic use in food animals. 

Final Guidance for Industry #213: What it does

  • Elaborates on the principles in Guidance #209.
  • Defines appropriate therapeutic uses of antibiotics in food animals as the “treatment, control, and prevention of specific diseases … necessary for assuring the health of food-producing animals.”
  • Asks drug companies to notify FDA of their voluntary decisions to remove “growth promotion” from their product labels, and to require a veterinary order or prescription for other approved uses in feed or water. FDA will evaluate the adoption rate three years from final publication of the guidance and will maintain a public list of products that should be modified under Guidance #213, along with the manufacturers of those products.3
  • Elaborates on the appropriate disease-prevention use of medically important antibiotics, informing veterinarians that such prescriptions are appropriate when “(1) there is evidence of effectiveness, (2) such a preventive use is consistent with accepted veterinary practice, (3) the use is linked to a specific etiologic agent [disease origin], (4) the use is appropriately targeted to animals at risk of developing a specific disease, and (5) no reasonable alternatives for intervention exist.”
  • Clarifies that drug companies must submit additional safety and effectiveness data if they add new uses or change the drug's components.
  • Establishes that FDA will approve new antibiotics only if they have specific dosing durations and levels for identified diseases and specific animals, not for entire herds or flocks.

Shortcomings of Guidance for Industry #209 and #213 and proposed remedies

  • No steps taken to rein in existing inappropriate uses for disease prevention. Although FDA did distinguish between appropriate and inappropriate uses of antibiotics for disease prevention, the agency should have asked drug companies to change their products' labels so that these drugs can no longer be administered to an entire flock or herd for indefinite periods without an identified disease.
  • No clear plan for evaluating program success. FDA has started listing products online that are targeted for compliance under Guidance #213 and has promised to report how many companies make the requested label changes. In addition, FDA should design a system to collect, analyze, and publish more detailed and useful data on food animal antibiotic sales, distribution, and use so that the agency and the public can measure whether Guidance #213 worked to eradicate growth promotion and over-the-counter use of antibiotics in animal agriculture. This system should immediately expand public reporting under the Animal Drug User Fee Act and collaborate with the USDA on alternative methods of data collection. FDA has formally proposed improved information-sharing under the drug user fee act, although it has not yet issued enhanced reports or proposed a rule to collect additional data that detail which types of animal antibiotics are used and for what purpose (that is, for growth promotion, disease prevention, treatment, or control). Furthermore, FDA should establish targets and timetables for reducing antibiotic use in food animals and should be clear with industry and the public about how and when it will report progress.

Proposed rule on the Veterinary Feed Directive: What it does

  • States that the proposed rule was developed in conjunction with Guidance #209 and Guidance #213 to require veterinary feed directives, or VFDs, for the use of certain medically important antibiotics in animal feed that are currently available over the counter.
  • Proposes updating and streamlining the existing requirements of VFD drug applications to facilitate transition of animal drug products into the VFD system.
  • As required, asks for public comment on changes being considered, including:
    • Ceding federal authority to states to define a valid veterinarian-client-patient relationship.
    • Providing veterinarians greater flexibility to authorize producer access to appropriate VFD drugs.
    • Setting a default expiration date for a VFD of six months unless otherwise indicated.
    • Streamlining administrative procedures and reducing record-keeping requirements.

Shortcomings of the draft Veterinary Feed Directive text and proposed remedies

  • Veterinary oversight definition is potentially weakened. FDA instituted a veterinary oversight requirement for the vast majority of food animal antibiotic use—which had previously been over-the-counter—yet the agency also removed the previous requirement of a valid veterinary-client-patient relationship and replaced it with varying individual state standards on veterinary oversight. To guarantee judicious prescribing in all states, FDA should reinstate the federal requirement of a valid veterinary-client-patient relationship as it is stated in the existing regulation. That is, it should require the veterinarian to have sufficient knowledge of the animals; to be personally acquainted with the keeping and care of the animals through examination and/or timely visits to the premises where the animals are kept; and to be available for follow-up.4
  • No clear limit on refills. The draft language does not clearly limit the number of times a VFD order can be reissued. This could allow food producers to use antibiotics for an indefinite period of time and on multiple generations of animals. FDA should limit the life of a VFD so that it does not extend past the life span of the animal, six months after the order is written, or the label directions, whichever is shortest. FDA should also limit automatic refills by requiring a veterinarian to re-evaluate the health of animals or herds before reissuing a VFD. 

References:

1 U.S. Food and Drug Administration, FDA Annual Report on Antimicrobials Sold or Distributed for Food-Producing Animals in 2011, Feb. 5, 2013,www.fda.gov/AnimalVeterinary/NewsEvents/CVMUpdates/ucm338178.htm.
2 Hearing before the House Subcommittee on Health, Committee on Energy and Commerce on antibiotic resistance and the use of antibiotics in animal agriculture, July 14, 2010, statement of John Clifford, Ali Khan, and Joshua Sharfstein
3 See: FDA, Applications Initially Affected by GFI #213, Jan. 23, 2014, www.fda.gov/downloads/AnimalVeterinary/SafetyHealth/AntimicrobialResistance/JudiciousUseofAntimicrobials/UCM378330.pdf.
4 See: §530.3(i) of Title 21 of Code of Federal Regulations, http://www.gpo.gov/fdsys/pkg/CFR-2013-title21-vol6/xml/CFR-2013-title21-vol6-sec530-3.xml.