So Much, But Yet Not Enough—The Administration’s Plan to Combat Antibiotic Resistance

By Diana R. H. Winters
[Cross-posted at HealthLawProf blog.]

Yesterday was a big day in the fight against antibiotic resistance. The White House released an Executive Order and a National Strategy document on Combating Antibiotic-Resistant Bacteria, the President’s Council of Advisors on Science and Technology (PCAST) released a report on antibiotic resistance, and the National Institutes of Health and the Biomedical Advanced Research and Development Authority announced a $20 million prize for developing tests to identify highly resistant infections. Kevin Outterson at The Incidental Economist, Food Safety News, and the New York Times provide a good summary of these developments.

It is clear that the administration recognizes the grave threat posed by antibiotic resistance and that it intends to make combating this danger a national priority. Its approach is broad—the National Strategy includes a “Guiding Principle” that “[d]etecting and controlling antibiotic resistance requires the adoption of a ‘One-Health’ approach to disease surveillance that recognizes that resistance can arise in humans, animals, and the environment,” and the strategy pays much attention to the role of antibiotics in food production. One main objective of the strategy is to eliminate the use of medically important antibiotics at subtherapeutic levels for growth promotion (the practice of feeding animals antibiotics to make them fatter, not to make them well).

But in regards to the use of antibiotics for growth promotion in animals, the strategy does not provide the tools, or even the rhetoric, to support meaningful movement towards decreasing their use. The strategy calls for FDA to implement Guidance #213, to enhance its data collection capabilities, and to increase educational outreach on the appropriate use of antibiotics. Guidance #213, issued in December 2013, is intended to provide drug sponsors with information as to how they can “modify the use conditions” of medically important antimicrobial drug products to limit use to that “necessary for assuring animal health,” and only under veterinary supervision. Not only do guidance documents not establish legally enforceable duties, the recommendations in Guidance #213 are characterized as voluntary. FDA, moreover, has known the dangers of using antibiotics in animal feed at subtherapeutic levels for four decades, and has been sitting on the information. Swift and strong action is needed now.

In 1972, an FDA task force stated concerns that the subtherapeutic use of antibiotics in animal feed can result in antibiotic-resistance. In 1977, the agency issued notices for a withdrawal hearing for the approval for the use of certain medically important antibiotics in animal feed. These hearings were never held, as FDA continued to seek information on the matter, Congress asked the agency to hold off, and other issues took priority. When brought to court in 2011 for the failure to hold these hearings, FDA defended itself, in part, by saying that it had established a voluntary program that would fix the problem. (I write about this history in an article on FDA delay forthcoming in the Indiana Law Journal in 2015.) FDA lost at the district court level. The court chided the agency for doing “shockingly little” to address the human health risks it had been aware of for over three decades. The court noted that the agency’s voluntary program was outside of the statutory scheme. This decision was reversed in July of this year on statutory interpretation grounds, which I wrote about here, with little interrogation of the agency’s voluntary approach.

There is some evidence that the voluntary approach is effective: FDA submitted letters to the Second Circuit stating that it was “‘encouraged’ by the ‘overwhelmingly cooperative’ reaction of the animal feed industry to the guidelines for voluntary compliance that the agency has issued in lieu of proceeding with the process initiated in 1977.”  And there is some evidence that the approach is not working. An investigative report issued last week by Reuters found the pervasive use of antibiotics for growth promotion in poultry. The report found information on feed tickets—documents issued to animal producers by feed-making mills—showing the use of antibiotics for growth promotion even among chicken producers that claimed only to use antibiotics to protect the health of chickens. Because FDA does not yet monitor or track the use of antibiotics in animal feed, there is no oversight of the voluntary compliance program touted by FDA—and highlighted in the new National Strategy.

The administration is talking the talk. Let’s see it do some walking.

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