The Food and Drug Administration (FDA), after decades of approving systematic application of antimicrobial drugs to food-producing animals, issued recommendations to phase out nontherapeutic use of these drugs. Historically, antimicrobial drugs were routinely introduced to livestock feed and water as a preemptive measure to preserve animal health. This ostensibly prudent practice, however, produced the unintended consequence of generating antimicrobial-resistant bacteria. The scientific community agrees that these mutant bacteria pose a significant threat to public health. Though the FDA’s nonbinding guidelines aim to curb this risk, they decidedly fall short of ensuring its elimination. As is often the case, the guidelines demonstrate government’s preference for incrementalism over sweeping transformation.
For those like myself, unfamiliar with microbiology, some basic background information may be helpful. The term “antimicrobial” refers generally to drugs that destroy or inhibit the growth of microorganisms, especially those which are pathogenic. Bacterial resistance arises because antimicrobial drugs kill non-resistant bacteria, while resistant bacteria survive and self-propagate. The likelihood for developing an antimicrobial-resistant bacteria corresponds to the frequency of drug use—each time a drug is used, the probability increases for producing antimicrobial-resistant bacteria.
Antimicrobial-resistant bacteria, sometimes referred to as “nightmare bacteria,” present a significant risk to people around the world. Public health leaders, including the Center for Disease Control (CDC), have expressed concern about the specific threat to human health posed by antimicrobial-resistant bacteria found in livestock facilities. As far back as 1970, an FDA Task Force concluded “treated animals might serve as a reservoir of antimicrobial-resistant pathogens that could produce human disease.” In 2013 the CDC issued a report finding the use of antibiotics, generally speaking, the single most significant factor contributing to antimicrobial resistance around the world. In the United States, each year two million people experience infections that are resistant to antimicrobial drugs designed to combat the specific bacterial infection. More strikingly perhaps, 23,000 Americans perish each year as a direct consequence of these antimicrobial-resistant infections.
In light of society’s reliance on these lifesaving medicines, why are food-producing animals being fed antimicrobial drugs? Exactly what do the new FDA guidelines call for? How effective will FDA’s guidelines be in combating public health risks? Finally, would a categorical prohibition on antimicrobial drugs in animal agriculture better safeguard public health? Though some degree of uncertainty pervades answering these questions, it appears rather certain the FDA has not gone far enough.
On April 11, 2012, the FDA published a guidance document (2012 Guidelines) setting forth two recommended principles that ought to govern use of medically important drugs in animal agriculture. The principles are:
(1) The use of medically important antimicrobial drugs in food-producing animals should be limited to those uses that are considered necessary for assuring animal health.
(2) The use of medically important antimicrobial drugs in food-producing animals should be limited to those uses that include veterinary oversight or consultation.
On December 11, 2013, the FDA published another guidance document (2013 Guidelines) describing measures the animal pharmaceutical industry should voluntarily undertake to condition use of medically important antimicrobial drugs on compliance with the two principles set forth in FDA’s 2012 Guidelines. In essence, the 2013 Guidelines encourage drug companies to alter product labels to condition use of medically important antimicrobial drugs on (1) it being “necessary for assuring animal health” and (2) obtainment of veterinary oversight or consultation. Bernadette Dunham, Director of the FDA’s Center of Veterinarian Medicine, says the 2013 Guidelines “promote[] 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.” Michael Taylor, deputy commissioner at the FDA for foods and veterinary medicine emphasized “what’s voluntary here is only the participation of animal pharmaceutical companies. Once these labeling changes have been made, animal producers will only be able to use these products with therapeutic reasons [and] veterinary oversight.” The animal pharmaceutical industry has significant power to reform animal agriculture practices because sections 512(a)(2) and (a)(4)(A) of the Food, Drug and Cosmetic Act prohibit use of drugs inconsistent with product labels.
So exactly how do these guidelines work together? Let’s assume for argument’s sake, the animal pharmaceutical industry has heeded the 2013 Guidelines by including the 2012 Guideline principles on product labels. This is a fairly big assumption. Next, a three-prong inquiry is required to determine whether the 2012 Guidelines are applicable. However, even if the 2012 Guidelines apply, the question remains whether these guidelines will ensure medically important antimicrobial drugs are judiciously administered to food-producing livestock. Turning now to the three-part applicability analysis for FDA’s 2012 Guidelines.
First, there is the threshold question of whether the antimicrobial drug is medically important. Medically important antimicrobial drugs are defined as “antimicrobial drugs that are important for therapeutic use in humans.” As demonstrated by this definition, the reach of these nonbinding guidelines extend only insofar as drugs possess medicinal utility for humans. Therefore, antimicrobial drugs which are not medically important fall outside the strictures of FDA’s guidelines.
In addition to being medically important, the 2012 Guidelines require antimicrobial drugs be “necessary for assuring animal health.” Presently, it is common practice in the livestock industry to administer low dosages of antimicrobial drugs in animal feed and drinking water. Nontherapeutic use, as this method is known, involves administering antimicrobial drugs not to target specific infectious bacteria, but rather to promote animal growth or increase food efficiency. Since nontherapeutic use by definition is not “necessary for assuring animal health,” such use of medically important antimicrobial drugs contravenes FDA’s 2012 guidelines.
In contrast, therapeutic use involves the administration of medically important antimicrobial drugs for treatment, control or prevention of specific infectious bacteria. Therapeutic use satisfies the “necessary for assuring animal health” standard. The Natural Resources Defense Council (NRDC), in a report issued January, 2014, argue FDA’s voluntary guidelines provide a loophole by including disease prevention as a basis for introducing medically important antimicrobial drugs. According to the 2012 Guidelines, “disease prevention involves the administration of an antimicrobial drug to animals, none of which are exhibiting clinical signs of disease, in a situation where disease is likely to occur if the drug is not administered.” The NRDC report contends “while FDA’s proposed guidelines would encourage drug manufacturers to discontinue selling drugs to speed up animal growth (“growth promotion”), it does not discourage the continuation of very similar or even identical uses as long as the intent is to prevent disease (“disease prevention”), even in cases where the animals are not sick and the use is driven by the anticipated effects of crowded and unsanitary conditions often found on livestock facilities.”
Scott Hurd, an opponent of regulating livestock practices and associate professor of veterinary diagnostics and animal medicine at Iowa State University, also recognizes this loophole. The inclusion of disease prevention as a justification for introducing medically important antimicrobial drugs is “something you will NOT find in the regulatory documents of many countries worldwide. Most ‘developing’ countries are moving away from any antibiotic of any kind, unless the pigs are falling over dead.” The fact both proponents and opponents of regulating drug use in animal agriculture acknowledge this loophole suggests the FDA’s 2012 Guidelines fall short of adequately protecting public health.
In addition to being medically important and used for therapeutic purposes, the 2012 Guidelines require antimicrobial drugs be procured with veterinary oversight or consultation. Animal pharmaceutical companies could make this happen by voluntarily changing the marketing status of medicated feed products from over-the-counter to veterinary feed directive, and over-the-counter to veterinarian prescription for medicated water products. “It’s a big shift from the current situation, in which animal producers can go to a local feed store and buy these medicines over the counter [sic] and there is no oversight at all,” said Taylor. Veterinary oversight could reduce unnecessary use of antimicrobial drugs. However, the disease prevention loophole still poses a significant risk of undermining the value of requiring veterinary consultation.
Remember this three-part applicability analysis is predicated on animal pharmaceutical companies instituting labeling alterations set forth in FDA’s 2012 Guidelines. The 2013 Guidelines include a timeframe by which animal pharmaceutical companies are encouraged to achieve compliance. From when the clock began ticking on December 11, 2013, animal pharmaceutical companies were given a three-month period to notify the FDA as to whether they intend to voluntarily alter product labels. As of March 26, 2014, 25 pharmaceutical companies have agreed to voluntarily institute the FDA’s 2013 Guidelines. These companies now have three years to complete reformation of product labels. If these companies fall short of satisfactorily executing the proposed changes, the FDA claims it will consider taking further action.
In the animal agriculture context, the FDA deems safe antimicrobial drug use where there is “reasonable certainty of no harm to human health from the proposed use of the drug in food-producing animals.” Scientific literature has demonstrated a serious public health risk posed by widespread use of antimicrobial drugs. In the face of this science-backed health risk, it’s perplexing that the FDA merely issued voluntary guidelines. To genuinely safeguard public health, the FDA should categorically prohibit nontherapeutic use of medically important antimicrobial drugs in animal agriculture. That would require going against a culture of incrementalism that pervades government decision-making, however. That would require guts.
