December 9, 2015
You have probably heard the oft-cited statistic that 80 percent of the antibiotics sold in the United States end up in food-producing animals rather than people. We know this because the Food and Drug Administration (FDA) requires drug manufacturers to report the amount, in kilograms, of antibiotics that are sold, and whether they are intended for use in food animal production or medicine.
What may surprise you is that we have no idea how the 14.8 million kilograms of antibiotics sold for use in food-producing animals are actually used on farms. We do not know where they are used, which animals receive them, which veterinarians prescribe them, or what diseases or infections they are intended to treat or prevent. This is because the FDA does not currently collect data on on-farm antibiotic use. Hopefully, this could change soon.
Ongoing data collection on antibiotic use is necessary in order to evaluate the success of federal efforts to stop antibiotic use for non-therapeutic purposes (Examples of “non-therapeutic purposes” include growth promotion and feed efficiency). With these data, we could examine how use changes over time and identify patterns that could ultimately drive research into recurrent disease risks or facilitate remedial action in the event of misuse.
The FDA held a comment period to gather recommendations for collecting on-farm antibiotic use and resistance data. The Center for a Livable Future submitted a comment with proposed methods for collecting and reporting these data, which are described below. We also recommended that a joint program be created—and funded—under the FDA, USDA, and CDC to collect and report antibiotic use and resistance data.
Beginning next year, a veterinarian will be required to issue a Veterinary Feed Directive (VFD) or veterinary prescription when antibiotics that are important in human medicine are given to farm animals. VFDs will contain information on the species, number of animals to be treated, location of the animals, date of treatment, name of the drug, indication for use, level of the drug, feeding instructions (including withdrawal time), and an expiration date. 
We believe veterinarians should be required to submit all VFDs and veterinary prescriptions to a centralized, electronic database that would aggregate information on the location, species, and number of farm animals receiving medically important antibiotics and the type and indication for use of those drugs. This system would function similarly to a prescription drug-monitoring program (PDMP), commonly used in human medicine. A de-identified version of the proposed database should be made available to the public, and annual reports should be released with national and state summaries of the prescription of antibiotics, comparisons among animal species, and summaries of disease and infection occurrence.
Veterinarians’ rapid reporting of VFD and prescription data, the de-identification of this information for an electronic database, and the public accessibility of such a database would provide quantitative, timely, and transparent data on antibiotic use in farm animals. These data are necessary to assess progress in the elimination of non-therapeutic uses of antibiotics and identify areas where more research or interventions are necessary.
The FDA has repeatedly acknowledged that any effort to collect antibiotic use data is contingent upon a funding stream that has not yet been identified. Our proposed system would have lower costs than other suggested methods of data collection because it would aggregate data from VFDs, records that veterinarians will be required to generate and keep, anyway.
As former CLF-Lerner Fellow Dr. Lance Price recognized in his public comment, the USDA has a history of allocating additional funds for special programs in times of crisis. Just this year, the USDA spent nearly $700 million in disinfection, clean-up, and indemnification payments following the avian influenza outbreak. The USDA, FDA, and CDC should recognize that we are in the beginnings of an antibiotic resistance crisis, and that tracking antibiotic use in farm animals is an important step toward characterizing and ultimately eliminating the misuse of these lifesaving drugs.
 Guidance for Industry #120: Veterinary Feed Directive Regulation. U.S. Department of Health and Human Services, Food and Drug Administration, and Center for Veterinary Medicine. September 2015.