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.

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