January 06, 2012
Earlier this week, the FDA announced new restrictions on the use of cephalosporins in livestock — big news for an agency that just before the holidays withdrew two 1977 proposals to restrict certain uses of penicillins and tetracyclines in animal feed and food-producing animals.
Under the new regulations, livestock producers are no longer allowed to use cephalosporin antibiotics at unapproved doses or with unapproved species, nor are they able to use the drugs prophylactically, to prevent disease. The FDA offers a few examples of extralabel uses that are prohibited: injecting cephalosporin antibiotics into chicken eggs makes the list, as do uses of human cephalosporin drugs in major food-producing species.
The FDA has tried restricting cephalosporins in livestock before. In 2008, the agency announced a more comprehensive ban of extralabel use of the drugs, but the action was later reversed. The new policy is a scaled-back version of the 2008 order of prohibition, with exceptions for extralabel uses deemed not likely to present a risk to the public health.
Restricting cephalosporins in livestock may be low-hanging fruit in the antibiotics in agriculture debate. As Superbug s Maryn McKenna explains, they are one of the least used classes of antibiotics in kilograms they account for only about .2% of the antibiotics sold for use in domestic food-producing animals in 2010. They aren t used at all for growth promotion a controversial practice that s been banned in the EU since 2006, but still accounts for a large portion of agricultural antibiotic use in the United States.
But, cephalosporins are an important class of antibiotics in human medicine, for both adult and pediatric use, and cephalosporin resistance is unfortunately already on the rise. Broad-spectrum cephalosporins are effective across a potentially large range of bacterial infections, and they ve become even more commonly prescribed over the past decade, due to increasing resistance to other classes of drugs (see the example of gonorrhea in the mid-2000s).
Over concerns about increasing resistance across classes of antibiotics, some advocates are calling on the FDA to do more. This is a modest first step by the FDA, but we re really just looking at the tip of the iceberg, Rep. Louise Slaughter, D-N.Y., told the Washington Post. We don t have time for the FDA to ploddingly take half-measures. We are staring at a massive public health threat in the rise of antibiotic-resistant superbugs. We need to start acting with the swiftness and decisiveness this problem deserves.
The FDA’s action is certainly one that will be applauded, as a first step, by public health advocates concerned about increasing antibiotic resistance and the role of agricultural antibiotics – which account for approximately 80% of antibiotics used in the U.S. – in hastening its spread. But it begs a few questions as well. First, how will the industry respond to the order, both rhetorically and in practice? Second, how does the regulatory action fit with the FDA s earlier announcement that the agency will pursue a voluntary reform, in cooperation with the livestock industry, to remove medically important antibiotics from agricultural use? Could there be more orders of prohibition in the pipeline, or is the limited action a signal of what the agency views as politically and economically feasible to regulate in the current climate? As discussed previously, banning nontherapeutic uses of antibiotics in livestock will likely mean a very significant overhaul in food-animal production practices in the United States, and it’s a process that the FDA seems to view as prohibitively resource-intensive to mandate.
