Friday, May 8, 2015

A Role for States in Antibiotic Regulation?

On April 13, 2012, the U.S. Food and Drug Administration (FDA) issued a guidance for industry, titled "The Judicious Use of Medically Important Antimicrobial Drugs in Food Producing Animals." Under this non-binding "Judicious Use" framework, the appropriate use of medically important antibiotics in food-producing animals is limited to those instances that are: (1) "considered necessary for assuring animal health;" and (2) "include veterinary oversight or consultation." However, some may find it troubling to learn that FDA lacks even basic data on antibiotic use in animal agriculture, making a determination of whether the industry is complying with the judicious use standard nearly impossible to obtain.

For more than three decades, scientists from various disciplines have been sounding the alarm over the use of antibiotics in animal agriculture, to no avail. While there is data to indicate a correlation between antibiotic use in livestock operations and antibiotic-resistant infections in humans, many in the industry are quick to point out that a causal link has never been established. Though not explicitly stated, the implication is that no causal link has been established because none exists. However, an absence of evidence is not evidence of absence. In order for scientists to determine whether a direct causal link exists, they need access to information about how, when, why, and to what extent antibiotics are being used. As stated above, FDA lacks this information. And, if the past is any indication, Congressional interference with FDA regulatory activities makes it unlikely that FDA will be able to gather this information in the near future.

One solution to this entrenched and rather contentious issue is for States to implement reporting requirements for antibiotic use in animal agriculture. Unlike the Federal Government, the States wield the police power, allowing them to regulate to protect the public health and safety. The States could simply require all animal agricultural operations to report their antibiotic use, and then share that information with FDA. This information would then help FDA determine whether additional regulatory action needs to be taken, including mandatory guidelines for use, or withdrawal of approval for antibiotics that pose a risk to human health. However, it’s no secret that the political process that takes place in State capitals is not so very different from what takes place on Capitol Hill. Whether the States would be willing to take on the role of regulator in this instance remains unclear.

No comments:

Post a Comment