Regulating the Antibiotic Resistance Crisis
A world in which no cure exists for strep throat, pneumonia, Lyme disease, or tetanus is closer than we might think. More than 2 million Americans suffer from antibiotic-resistant infections—know as “superbugs”—and thousands die from them each year.
Recent California legislation has the potential to tackle the growing antibiotic resistance crisis, argues a legal scholar in a recent paper. But to do so, the California state government needs to invest sizable resources in fine-tuning the law’s data collection mechanisms and also make sure it does not conflict with federal law, according to Emilie Aguirre, a doctoral student at Harvard Business School.
Industrial farmers routinely give antibiotics to livestock to promote growth and prevent disease-spreading in unsanitary environments. Aguirre contends that, although antibiotics may only be used in small doses in the food industry, they nevertheless contribute to the proliferation of antibiotic-resistant bacteria.
To combat the proliferation of such superbugs, the California legislature in 2015 passed Senate Bill 27—known as SB 27 for short. The law aims to minimize the feeding of antibiotics to animals, and it prohibits the use of antibiotics “solely for purposes of promoting weight gain or improving feed efficiency.” Moreover, SB 27 is the first law in the United States to constrain the use of antibiotics in food-producing animals, according to Aguirre.
SB 27’s success, Aguirre contends, will depend in part on its ability to fit into a larger, multi-level system of governance. She argues that the federal government must first identify public health goals for the country. State governments will then take responsibility for achieving these goals, and, in so doing, local companies will receive delegated authority from states to experiment.
Prior to the passage of SB 27, the federal government had already declared its intention to tackle the antibiotic resistance crisis, writes Aguirre. The U.S. Food and Drug Administration issued a guidance document in 2012 that provides a blueprint “for the voluntary adoption of practices to ensure the appropriate or judicious use” of antibiotics use in the livestock industry.
The Obama Administration also subsequently formulated a National Action Plan for Combating Antibiotic-Resistant Bacteria, bringing to the table several agency heads, including the Secretaries of Defense, Agriculture, and Health and Human Services. Under the plan, the federal government, together with health care organizations across the world, intend to develop quick and innovative diagnostic tests for identification and characterization of antibiotic-resistant bacteria, among other things.
Despite the potential of the Obama Administration’s plan, Aguirre argues that the federal government has yet to enforce “a coherent, robust legal scheme” to cut the use of low-dose antibiotics in the livestock industry. In the absence of federal action, California appears to assume the mantle of leadership when it comes to addressing the antibiotic resistance crisis.
But Aguirre fears that these regulatory mandates are too weak.
For Aguirre’s proposed framework to work, the California Department of Food and Agriculture will have to coordinate and compare practices among local companies to determine best practices. In doing so, Aguirre argues, the Department will have to establish benchmarks for what constitutes an advanced livestock management practice and then develop mechanisms to collect data on whether those benchmarks are being met—something California has yet to establish.
Many European countries could act as models for California regulators, Aguirre suggests. For instance, the Netherlands reduced its use of antibiotics by 56 percent between 1999 and 2004. It did so through a series of stringent data collection programs that required veterinary registration of all prescribed antibiotics, as well as the creation of an independent institute to monitor antibiotic use, report data, and set benchmarks for antibiotic use.
Aside from data-related issues, Congress may try to use a legal doctrine known as federal preemption—which occurs when federal law conflicts with state law, rendering the latter void—to undermine SB 27 by preventing California from legislating in the area of its choosing.
The Federal Food, Drug, and Cosmetic Act (FDCA) of 1938 requires that “human and veterinary drugs are safe and effective.” Although the FDCA applies to the distribution of “any drug intended for use for animals,” thus overlapping with SB 27, Aguirre argues that SB 27 should survive a federal preemption challenge. Indeed, federal preemption law provides an exception if a state law “furthers federal objectives” and supports a compelling state interest “in protecting the health and safety of its citizens.” Fulfilling both conditions in this case, SB 27 should remain good law, Aguirre predicts.
To avoid living in a world without effective antibiotic treatment, California must implement SB 27 with care and ensure its survival under federal preemption, Aguirre concludes.
Source: Regulatory News