On December 11, 2013, the Food Drug Administration (FDA) issued guidelines aimed at phasing out the use of antibiotics that are critical to human health in food-producing animals, including penicillin, azithromycin and tetracycline. Aside from treating infections in animals, livestock producers have been using antibiotics to induce growth in an animal and maximize feed. The FDA proposed these guidelines in draft form more than a year ago, committing itself to ending the overuse of these antibiotics in animals by livestock producers in response to public health concerns over increased antibiotic resistance. The document “lays out such a strategy and marks the beginning of the formal implementation period”.
The non-medical use of antibiotics to promote growth in livestock has been found to be largely responsible for the growing resistance to antibiotics. Currently, an estimated 100,000-200,000 tons of antibiotics are produced each year, and 70 percent are destined to animals. The amount of antibiotics used for agricultural, horticultural, and veterinary purposes far surpasses the amount used for human medical purposes (by a factor of four). Livestock producers have argued not only that the use of antibiotics for animal growth minimally adds to the antibiotic resistance that we are experiencing (despite growing evidence to the contrary), but also that the transfer of bacteria from animal to humans is rare. However, recent studies have questioned existing skepticism over whether antibiotic resistance can be transferred from animal to humans. In fact, there is a study currently being conducted to find the extent to which grocery meat causes urinary tract infections in women. The results are forthcoming.
The fear is that if we do not halt the overuse of antibiotics for animal growth, the “20th century miracle drug” (as antibiotics have been called) will cease to combat what are currently considered ordinary and easily-treatable infections, such as strep-throat. The result is bound to be catastrophic—more and more people will experience infections of longer duration, greater number of people will die from drug-resistant infections, and accessibility and availability of effective treatment will be more difficult as we become more dependent on more expensive, newer-generation antibiotics, particularly for those in low- and middle-income countries. There is also the question of whether research and development of new drugs can keep up with growing resistance to currently existing antibiotics. Concerns and efforts by health officials over the indiscriminate use of antibiotics in animals and drug resistance date back to the 1970s, but the food industry has utilized its strong lobbying power to undermine them.
If all goes according to plan, the recently issued guidelines will make the use of these antibiotics for animal growth illegal in three years. The guidelines call on animal pharmaceutical companies to do away with “growth promotion” and “feed efficiency” on the label of antibiotics that are used to in human medicine. Companies are being asked to express in the next three months their commitment to adhering to the guidelines, after which they have three years to implement the changes. Additionally, the FDA proposes modifying the current Veterinary Feed Directives (VFD) process so that antibiotics “medically important” for human health that are presently available over the counter are only made available with a prescription from a licensed veterinary.
Those in favor of prohibiting the use of antibiotics for animal growth have been pressuring the FDA to take serious steps towards addressing this public health problem. While the FDA has indeed committed itself to the cause and has issued these guidelines, at the end of the day, they are merely voluntary—it leaves it to the animal pharmaceutical companies to decide whether they will comply with them. The FDA’s deputy commissioner for foods and veterinary medicine, Michael Taylor, has argued that, “based on [their] outreach, [they] have every reason to believe that animal pharmaceutical companies will support [them] in this effort.” The FDA has spent the last few years working with stakeholders across sectors on the issue. Nevertheless, there is skepticism. Considering that companies are being asked “to voluntarily withdraw approvals to use antibiotics in food animals for ‘growth promotion’ while keeping approvals to use these drugs for ‘disease prevention,’” Johns Hopkins Center for a Livable Future has expressed concern that the guidelines can lead livestock producers to continue low-dose use of antibiotics in their animals by claiming “disease prevention.” It is worth noting, however, that Elanco and Zoetis (two veterinary pharmaceutical companies) have already declared their commitment to following the FDA’s guidelines. Similarly, the Animal Health Institute (an organization of animal pharmaceutical companies) has also expressed its support. Other companies include Merck & Co, Novartis AG, Sanofi and Bayer AG.
William Flynn, DVM, MS, deputy director for science policy at FDA’s Center for Veterinary Medicine (CVM), explained that “the final guidance document made participation voluntary because it is the fastest, most efficient way to make these changes.” Let us hope that this is indeed the case—too much is at stake.
Posted in FDA ; Tagged: animal, Animal Health Institute, Antibiotic resistance, Antibiotics, Bayer, Center for Veterinary Medicine, drug, drug companies, drug resistance, drugs, Elanco, infectious diseases, Johns Hopkins, Johns Hopkins Center for a Livable Future, Merck, Novartis, Pharmaceuticals, public health, Sanofi, Zoetis.
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The views reflected in this blog are those of the individual authors and do not necessarily represent those of the O’Neill Institute for National and Global Health Law or Georgetown University. This blog is solely informational in nature, and not intended as a substitute for competent legal advice from a licensed and retained attorney in your state or country.