Human antibiotic resistance has been on the radar for several years, but did you know that antibiotic-resistant infections kill 23,000 people in the U.S. and make another 2 million sick each year? Some of this resistance has come from medical overuse of antibiotics. (Think of tired parents asking for drugs for their toddler’s ear infections, which are largely viral in origin and thus immune from antibiotics’ quick fix.) But another large source of exposure is through eating conventionally raised meat in the U.S. That’s why the media has given so much attention yesterday and today to the FDA’s recent request to antibiotic manufacturers to rewrite labels so that the drugs can only be used to treat illness via veterinarian prescription and not presumptively added to animals’ food and water.
Through the new labeling, the FDA hopes to reduce “subtherapeutic” use of antibiotics in livestock, characterized by current industry practice of administering daily, low doses to inhibit disease and accelerate growth. In revising drug labels, the FDA asks drug companies to remove “growth promotion” or “feed efficiency” as a legal use of any drug that is also used in human medicine. If those uses do not appear on the label, farmers can no longer legally use the drug for them.
Here is how the FDA explains its actions:
FDA is taking action to promote the judicious use of medically important antimicrobial drugs in food animals. The goal of the strategy is to work with industry to protect public health by releasing two documents to help phase out the use of medically important antimicrobials in food animals for production purposes (e.g., to enhance growth or improve feed efficiency), and to bring the therapeutic uses of such drugs (to treat, control, or prevent specific diseases) under the oversight of licensed veterinarians.
This new FDA policy, which has been in the works for a year, is voluntary – a point that is criticized by public health advocates. Big pharma now has three months to say whether it will accept the labeling changes recommend in this guidance document, then three years to comply – another weakness that critics point out. Some suggest that U.S. policymakers can learn from their European counterparts, for example the Netherlands’ establishment of absolute limits and fines for noncompliance. Today’s NYT provides a fuller picture of the debate.
What I didn’t see in the Times or NPR’s coverage was reporting on how the industry and government regulators arrived at this point of compromise. Certainly it includes quotes from the pharma and animal food industries saying that this will not radically alter their practices (and bottom lines). In fact, NPR characterized this response as the “bigger news”: that the two largest veterinary drug companies, Elanco and Zoetis, announced they would follow the FDA guidance, and that the livestock professional association, the Animal Health Institute, supports them.
The coverage implicitly points to the process of regulation – the regulatory dance – that FDA, an agency with relatively weak powers, engages in with the private sector. A kind of waltz. First step, a period of study. Second, proposals to regulate that are floated for a year or so. Third, a final regulatory act (here, industry guidance) that is implemented over a time period long enough to facilitate industry adaptation. All the while consumers, via advocacy and research groups like the NRDC and Pew, pay attention (and sue) and begin to shift buying decisions, which signals producers to adjust or perish — and makes it easier for the FDA to ultimately assert its official but weak authority. Hence the agency’s stronger influence comes from the public health work done quietly apart from formal rulemaking — namely using its delegated authority to collect data, analyze it, and make it publicly available — and then “taking the lead” to codify health safety standards that are evolving into new norms of industry practice. The last and most obvious point in the three-step regulatory waltz on this point of tension between manufacturing practice and public health.
UPDATE: This 1/2/14 Bloomberg report on several companies’ (notably McDos’) lackluster performance on self-imposed policies to reduce antibiotics in meat calls into question the potential success of FDA’s “new” voluntary guidelines.
UPDATE: This 1/30/14 law review article, “The FDA’s Lame ‘Judicious Use’ Policy for Livestock Antibiotics”, by Lisa Heinzerling of Georgetown Law, unequivocally slams the FDA’s voluntary approach: “Together, the documents recently issued by the FDA promise little more than continued delay in tackling a public health risk that has bedeviled the agency for decades. The FDA’s decision to rely on voluntary action by drug companies and to continue to allow routine uses of antibiotics in whole herds and flocks of animals in order to prevent infections brought on by stressful conditions leave gaping holes in the protection the agency purports to provide. The agency’s meager backup plans in case this endeavor does not work out as it hopes do little to comfort the skeptical. Moreover, the FDA’s proposal to weaken rules for veterinary oversight undermines the agency’s plan to place veterinarians at the front line of preventing agricultural overuse of antibiotics. In addition, after a small outburst of transparency at the very start of the process, this whole undertaking will move underground for three years while the FDA works things out privately with participating drug companies. Rather than pursuing this doomed course, the FDA should do what a federal district court has already ordered it to do: complete regulatory proceedings to withdraw approvals for the mass administration of medically important antibiotics to food-producing animals. The FDA’s refusal to do so rests on the mistaken legal premise that such withdrawals must be preceded by formal, trial-type hearings; this premise ignores decades of developments in administrative law and misreads the agency’s own enabling statute.”