FDA's strong words and weak enforcement - will a voluntary ban on antimicrobials change industry practice?

12 Apr 2012
Andrea Titus

Yesterday, the FDA took another step towards restricting the use of antimicrobials in farm animals in the United States, finalizing guidance for farmers and drug companies to begin voluntarily phasing out the drugs.

Animal use has never been a focus area within Extending the Cure, CDDEP’s U.S.-based antibiotic resistance project.  Instead, ETC focuses on the drivers and consequences of human antibiotic use.  But antibiotics in U.S. livestock is a big industry – it’s estimated that agriculture accounts for up to 80% of total antibiotic use in the country – and the past few months have seen a great deal of movement around the issue. 

While the FDA has spoken against antimicrobial use in livestock in the past, yesterday’s unequivocal statement from the FDA is a stronger rhetorical step towards affirming the links between animal antibiotic use and the development of antibiotic resistance.  From the FDA’s press release: “[b]ecause it is well established that all uses of antimicrobial drugs, in both humans and animals, contribute to the development of antimicrobial resistance, it is important to use these drugs only when medically necessary…Today, the FDA is issuing three documents that will help veterinarians, farmers and animal producers use medically important antibiotics judiciously in food-producing animals by targeting their use to only address diseases and health problems.” The “three documents” released yesterday are the following:

  • The final draft of a set of recommendations aimed at “phasing out the agricultural production use of medically important drugs and phasing in veterinary oversight of therapeutic uses of these drugs”
  • New draft guidance to help drug companies revise drug labels towards antimicrobial use that is necessary for animal health, with veterinary supervision
  • A draft document which outlines veterinary oversight for antimicrobials in animal feed


But despite the strong sentiment about the importance of preserving antimicrobials for medically necessary purposes, the FDA guidance lacks some of the teeth that stewardship advocates have been seeking.  The Center for Science in the Public Interest called the announcement “tragically flawed,” because it depends entirely on the industry’s voluntary compliance with the guidance document.  Similarly, Margaret Mellon of the Union of Concerned Scientists challenged the agency on its strategy, saying:

“The approach announced represents a bold, well-intentioned attempt by the FDA to persuade an entire industry to voluntarily abandon claims that allow them to sell a large number of lucrative products. The agency should be congratulated for finally taking action on a serious and long-neglected public health issue, but we’re deeply skeptical that the approach will work.”

And, there are concerns about the definition of "judicious use." Although the guidance disallows antibiotics for growth promotion purposes, Tom Philpott at Mother Jones suggests that, in practice, it may be difficult to distinguish the small doses of antibiotics administered for growth promotion from the small doses administered to prevent disease.  What’s the point, he argues, if compliance with the new guidelines won’t change practice? 

Regulatory action, and enforcing a ban on a large number of antimicrobials for “production” purposes, would likely be a large undertaking for the agency, which notes that a ban on a single drug could result in years of legal appeals.  But that concern doesn’t offset the unease that some groups feel towards the agency’s current strategy.  While FDA states that it will evaluate the success of the voluntary program in three years, organizations like UCS and CSPI will likely continue to put pressure on the agency to do more.  And as they do, the FDA has given those groups yet another powerful statement for which they can be held accountable.

Image credit: Flickr: northdevonfarmer

Antibiotic Resistance