More than 80% of the antibiotics used today are for agricultural use (and not humans).* If you think that the FDA has been properly regulating the “subtherapeutic” use of antibiotics in livestock and poultry—that is, a dosage that’s lower than that to treat disease, and is instead used for stimulating animal growth and improving feed efficiency—think again. Antibiotics are routinely added to animal feed and water without, in my opinion, remotely enough oversight.
In fact, such use of pencillin and two types of tetracycline has been taking place since the 1950s without any push by the FDA to have drug makers prove safety, all despite mounting evidence since that time that subtherapeutic dosing favors, and indeed has created, antibiotic resistant bacteria that are harmful to animals and humans. This is the landscape of our food supply, and most people are completely unaware that it is taking place, let alone of the consequences that have come as a result.
Thankfully, the FDA (and other related agencies) were recently given a long overdue wake up call from federal court, and ordered to complete an oversight process that was started in the 1970s, but never completed.
On March 22, 2012, the United States District Court for the Southern District of New York (Katz, J.) issued its 55 page Memorandum Opinion and Order in Natural Resources Defense Council et al. v. United States Food and Drug Administration et al., 11-Civ.-3562. In the Order, the court granted the Plaintiffs’ motion for summary judgment, and ordered the FDA Commissioner (or the Director of the Center for Veterinary Medicine, a subdivision within the FDA) to complete mandatory withdrawal proceedings for penicillin and two forms of tetracycline “applications”, a process that the FDA started in the mid-1970s—after already more than two decades of “subtherapeutic” administration to herds and flocks that began in the 1950s—but never completed despite significant evidence that such use was creating antibiotic-resistant “superbugs” that were harmful and sometimes fatal to humans.
By way of brief background, once the FDA began receiving data in the early 1970s from its task force (convened to study the risks of this kind of antibiotic use), the FDA issued a regulation in 1973 that the FDA proposed to withdraw approval of all subtherapeutic uses of antibiotics in animal feed, unless the drug sponsors and other interested parties submitted data within two years that indicated safety. Twenty drug makers and other interested parties responded in kind and requested hearings on the issue. While the FDA granted those hearing requests, it never ultimately set dates for or held hearings. From that point on, the FDA essentially went dark on the issue, and subtherapeutic use of penicillin and tetracycline in agriculture continued with status quo for more than two decades. This unfettered use is what led to the 2011 lawsuit filed by various advocacy groups that wanted to force the FDA to finish its job and, ultimately, withdraw approval for subtherapeutic antibiotic use.
The court’s March 2012 order means that the agency will now have to complete the process of having the drug sponsors (a/k/a drug companies and others) prove that the use of these antibiotics is safe. The FDA must do this by 1) re-issuing a notice of the proposed withdrawals and provide opportunity for a hearing for drug sponsors; and 2) if drug sponsors request hearings and raise a genuine and substantial issue of fact, the FDA must hold a public evidentiary hearing, (a process that should have happened in the late 1970s). If the drug companies fail to prove safety at the hearing, the FDA must issue a withdrawal order that will end the use of such antibiotics in agriculture at “subtherapeutic” levels.
As a lawyer, these kinds of in-depth, well-reasoned decisions issued by courts give me comfort that the judiciary is paying attention not only to the law (the Food, Drug & Cosmetics Act and the Administrative Procedures Act), but also the tactics of the FDA in skirting their duties. For example, in December 2011, just a few months after the suit had been filed, the FDA rescinded their original 1977 notice of opportunity for hearing (NOOH) regarding the withdrawal proceedings for penicillin and tetracycline. To do this after twenty-five years of no interim action, much less during an ongoing lawsuit related to this very issue, speaks volumes about the FDA’s laissez faire stance on antibiotic use. Indeed, their tactic was calculated: by rescinding the order, they had hoped to make the Plaintiffs’ case moot and have it dismissed. Fortunately, for reasons set forth in the decision, the court did not fall for this tactic and issued its order nonetheless.
What’s perhaps most troubling about the FDA’s failure to properly address safety data and growing scientific evidence about increasing instances of antibiotic resistant bacteria is that they are doing so at a huge risk to humans and animals, seemingly in an effort to appease drug makers and many agricultural proponents of subtherapeutic antibiotic use. Decades of unchecked antibiotic use in agriculture is already demonstrating serious consequences, and those are just the ones that we know of now. Thankfully, groups like the ones that brought the suit are acting on the best interests of public health and finally the courts are starting to force the FDA to do the same.
Stay tuned over the next few days for Part 2, where I discuss the final guidance, draft guidance and draft regulation issued by the FDA yesterday (Wednesday, April 11, 2012), apparently in an effort to increase regulation of antibiotic use. However, the fact that guidance merely voluntary and non-binding does not give me much hope when considering the drug makers’ and FDA’s position on this issue to date. Click over here to read the FDA’s press release regarding and links to these documents.
* The use of antibiotics for promoting growth or added to feed is prohibited under the National Organic Program. Under the NOP any animal that is treated with antibiotics for disease must be removed permanently from the herd and cannot be labeled organic.
Copyright (c) 2011-2012 by Kristen M. Ploetz and Green Lodestar Communications & Consulting, LLC. All rights reserved.