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A fact sheet from March 2015 FDA Policies on Antibiotic Use in Food Animal Production Surveys of the animal production industry by the U.S. Department of Agriculture demonstrate that industrialscale facilities frequently administer antibiotics to animals at low doses for nontherapeutic purposes—a practice 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 2012, over 32 million pounds of antibiotics sold in the United States were for food animals – a 16 percent increase since 2009.1 Many large meat and poultry producers administer low doses of antibiotics to healthy food animals to offset the effects of overcrowding and poor sanitation and to promote faster growth, not to treat animal disease. FDA, USDA, and the Centers for Disease Control and Prevention all 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 landmark policy documents on the use of medically important antibiotics in food animal production—an important step toward curbing the inappropriate use of antibiotics in this industry: •• Final industry guidance: “Draft Guidance for Industry on New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: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 213.” •• Draft rule: “Veterinary Feed Directive.” All of these policy documents, however, have gaps that need to be addressed to slow the growing public health crisis of antibiotic resistance. It is important to note that the guidance is voluntary, meaning companies are not required to follow them. Final Guidance 213: What it does •• 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 product labels; FDA will evaluate the adoption rate three years from final publication of the guidance. •• Clarifies that drug companies can change use claims and marketing status without submitting additional safety or effectiveness data unless they are claiming new treatment uses or changing the makeup of a drug. FDA guidances are voluntary, yet the vast majority of antibiotic companies have indicated they will comply. •• States that new drug uses must have a specific dosing duration and level for an identified disease and be available only to certain animals, not an entire herd or flock. •• Establishes criteria to justify the use of antibiotics for “disease prevention.” Shortcomings of Guidance 213 and proposed remedies •• No restrictions on disease prevention. While FDA defined appropriate disease prevention uses, it should go further and work with drug companies to remove indications that are inconsistent with this definition. This is especially important since disease prevention uses are very similar and sometimes identical to low-dose growth promotion uses and may allow the use of subtherapeutic antibiotics to change on paper but persist in practice. Disease prevention is inappropriate except to control a known disease threat at the sufficient dosage and duration to kill bacteria in a limited group of animals for a limited period of time. Legitimate prevention should not include conditions in which diseases recur and antibiotics are used over multiple production cycles, especially for entire herds or flocks. •• No stated plan for evaluating program success. FDA should design a system to collect, analyze, and publish more detailed and useful data on food animal antibiotic sales, distribution, and use. This system should immediately expand public reporting under the Animal Drug User Fee Act, and FDA should collaborate with USDA on alternative methods of data collection. FDA should establish targets and timetables for reducing antibiotic resistance in food animals and should be clear with industry and the public about how and when it will report progress. Draft veterinary feed directive rule: What it does •• To facilitate transition of animal drug products into the veterinary feed directive system, or VFD, proposes updating and streamlining the existing requirements of VFD drug applications. •• Asks for public comment on some of the key changes being considered, including: •• Removing the valid veterinarian-client-patient relationship requirement to enable veterinarians to issue a VFD within the course of their practice without necessarily having professional interaction with the animals or visiting the premises. •• Providing veterinarians greater flexibility to authorize producer access to appropriate VFD drugs. •• Streamlining administrative procedures. •• Asks for comments on the practical implications of VFD changes for animal producers, particularly those with smaller operations in remote locations. 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, which could enable veterinarians to issue a VFD within the course of their practice without necessarily having professional interaction with the animals or visiting the premises. ••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 feeddirective text and proposed remedies •• Veterinary oversight is not well-defined. FDA should reinstate the current requirement of a valid veterinaryclient-patient relationship as it is stated in the existing regulation.3 A federal requirement is necessary because the definition in most states of the veterinarian-client-patient relationship does not clearly apply to a VFD, and some states have no definition at all. •• Shortened record-keeping requirements. The proposed rule states that feed mills, producers, and veterinarians must keep records for only one year from date of receipt and distribution. Pew recommends that all involved parties retain a copy of the VFD and any other required records for at least two years, as required in the existing regulation. •• No limits on refills. The draft language does not adequately limit the duration of a VFD order or the number of times it can be reissued. This could allow use of antibiotics for an indefinite period of time and for multiple groups of animals. FDA should ensure that the expiration date of the VFD does not extend past the life of the targeted animals, six months after it is written, or the label directions—whichever is shortest. This provision will decrease the chances that antibiotics are reordered without a legitimate, identified need. Endnotes 1 U.S. Food and Drug Administration, “FDA 2012 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals”, http://www.fda.gov/downloads/ForIndustry/UserFees/AnimalDrugUserFeeActADUFA/UCM416983.pdf 2 Antibiotic resistance and the use of antibiotics in animal agriculture, hearing before the House Committee on Energy and Commerce, Subcommittee on Health, July 14, 2010, statement of John Clifford, Ali Khan, and Joshua Sharfstein, http://pewhealth.org/reportsanalysis/issue-briefs/official-text-hearing-on-antibiotic-resistance-and-the-use-of-antibiotics-in-animal-agriculture-85899370904. 3 See: §530.3(i) of Title 21 of the Code of Federal Regulations, http://www.gpo.gov/fdsys/pkg/CFR-2013-title21-vol6/xml/CFR-2013title21-vol6-sec530-3.xml. For further information, please visit: saveantibiotics.org Contact: Shannon Heyck-Williams, government relations officer, The Pew Charitable Trusts Email: [email protected] Phone: 202-887-8801 Project website: saveantibiotics.org The Pew Charitable Trusts is driven by the power of knowledge to solve today’s most challenging problems. Pew applies a rigorous, analytical approach to improve public policy, inform the public, and stimulate civic life.