Another Day, Another Underwhelming FDA Move on Antibiotics

NRDC and Friends Petition FDA for Strong Action

FDA held a stakeholder call yesterday to announce that it plans to invite feedback on whether it should ask drug companies to voluntarily limit the duration that livestock producers may feed livestock and poultry a specific antibiotic product. The agency reports that currently a substantial portion of antibiotics products approved for use in feed and water have no limits on duration of use, meaning the producers may legally feed them to animals indefinitely. While adding limits sounds like a step in the right direction, we fear FDA’s call for comments may actually mark the start of another multi-year conversation on an issue that FDA should be moving decisively on and that, on its own, will ultimately do little to reduce drug use.   

Here’s why FDA’s announcement yesterday is so underwhelming:

  • This concerns recommendations that FDA may make in the future.  There is not a proposal for action here, and certainly nothing mandatory.
  • Moreover, even if time limits followed from this announcement, examples of time limits cited by FDA include 16 weeks for chickens, a period that covers a broiler chicken’s entire lifetime.  In a prior guidance, FDA had identified more than 21 days of use on a group of animals as a high risk factor—that’s nowhere reflected in FDA’s approach here.
  • Even if the recommended time limits were to be reasonable, antibiotic use could continue for an extended period if different drugs were sequenced together or alternated.
  • Finally, even if a recommendation from the agency materialized, it would concern only antibiotics which may currently be used for an indefinite period. Other routine uses of antibiotics, even if approved for extended periods of use, would not be affected. So, even if everything else goes swimmingly, FDA would continue to condone all routine use of antibiotics on animals that are not sick, as long as there is some time limit on use (no matter how long) and that use is dressed up in the language of “disease prevention,” i.e. to compensate for stressful, crowded, and unsanitary conditions.  FDA defines “disease prevention” as “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.”  (Emphasis added).

Right now, essential medicines are losing their effectiveness, presaging longer illnesses that are harder to treat and reducing doctors’ ability to use many procedures such as surgeries and chemotherapy. After the recent discovery in the US of the presence of bacteria resistant to an antibiotic of last resort, a leading scientist said, “If our leaders were waiting to act until they could see the cliff’s edge -- I hope this opens their eyes to the abyss that lies before us.” The time for strong action is now.

All this is not to say that defined durations of use for livestock antibiotic drugs are a bad idea (even though all FDA is doing is asking for input on whether it should consider recommending some kind of time limit sometime in the future). Meaningful limits on durations of use for livestock antibiotic drugs could be a part of a set of reasonable restrictions on antibiotic use for animals that are not sick—so that the use does not drive the proliferation of antibiotic-resistant bacteria. The problem is that FDA’s announcement is emblematic of a persistent pattern of aiming far, far too low. FDA continues to fiddle at the edges of real solutions for curbing livestock antibiotic use. Yesterday’s announcement seems like more of the same. What we need from FDA is big, bold efforts that really address the crisis of antibiotic resistance—discontinuation of the use of antibiotics for disease prevention and targets for the reduction of antibiotic use—that have already been successfully modeled by Denmark and Netherlands without economic harm.

Which is why today NRDC and several other organizations filed a petition calling on FDA to act to stop the sales of livestock antibiotics for routine use to “prevent disease.” Read more about it here in a blog by my colleague, Jonathan Kaplan.