Court Scolds FDA Over Ag Antibiotic Use

There's been another development in the continuing court battle to get the US Food and Drug Administration to exert some control over agricultural use of growth-promoter antibiotics -- and it arrives accompanied by some remarkably direct language from the US magistrate judge hearing the case.

In a Memorandum of Opinion and Order that was filed last Friday afternoon -- which I extracted from the PACER system and stashed in my Scribd account -- Judge Theodore Katz addresses the FDA's denial of two citizens' petitions regarding ag antibiotic use. I'll explain the details below, but here is the key language:

... the Court finds the Agency's denial of the Petitions to be arbitrary and capricious. For over thirty years, the Agency has been confronted with evidence of the human health risks associated with the widespread sub-therapeutic use of antibiotics in food-producing animals, and, despite a statutory mandate to ensure the safety of animal drugs, the Agency has done shockingly little to address these risks.

Whew. OK, the details:

A little more than a year ago, a coalition of nonprofit advocacy groups -- the Natural Resources Defense Council, Center for Science in the Public Interest, Food Animal Concerns Trust, Public Citizen and Union of Concerned Scientists -- sued the FDA over its non-action on sub-therapeutic or growth-promoter antibiotic use. The suit made two major claims (initial post on it here):

• that the FDA failed to fulfill its regulatory responsibility to monitor and withdraw from the market drugs that are shown to be unsafe, given that it found in 1977 that using penicillin and tetracycline as growth promoters would increase antibiotic resistance; and
• that the FDA failed to fulfill its regulatory responsibility to respond to citizen petitions alleging harm from drugs that it had approved, given that it ignored petitions by the same groups, regarding growth promoters, that were filed in 1999 and 2005.

In March, Judge Katz found for the advocacy groups on the first claim, and ordered the FDA to start addressing whether approval for growth-promoter use of those two drugs should be withdrawn. (Posts on that here and here.) Two weeks ago, the FDA notified the court it would appeal that decision. (Notice of appeal also up at my Scribed.)

Today's action addresses the second claim: that the FDA not only didn't follow its own rules, but also didn't respond to citizen attempts to get it to follow its rules. The actual back-and-forth is a little more complex than that, because in last November -- after this suit had been filed -- the FDA actually, belatedly, denied the citizen petitions, while in January, the suit was amended, reframing the claim of non-response to one of arbitrary denial.

All of this took place against a backdrop of the FDA announcing that, instead of taking regulatory action on the long-suspended findings of growth promoters being unsafe, it was going to pursue getting agriculture to voluntarily reduce its antibiotic use. (Posts on that here, here, and here; FDA made that alternative, embodied in its Guidance 209, final in April.)

In his opinion, Judge Katz says this alternative is not adequate:

... the Agency has refused to make any findings and instead intends to adopt a voluntary program that is outside the statutory regulatory scheme. The adoption of voluntary measures does not excuse the Agency from its duty to review the Citizen Petitions on their merits. The Agency must evaluate the safety risks of the petitioned drugs and either make a finding that the drugs are not shown to be safe or provide a reasoned explanation as to why the Agency is refusing to make such a finding.

In its court filings, the FDA contended that continuing the regulatory process it started in 1977 -- when it published a Notice of Opportunity for a Hearing (NOOH) on the possibility of yanking licensure for penicillin and tetracycline growth promoters -- would be too time-consuming. On this, Judge Katz is stinging:

... the FDA is refusing to follow the statutory mandate of withdrawal proceedings on the ground that such proceedings are not effective because they take too long. Yet, the Petitions at issue have been pending for thirteen and seven years, respectively. The position that instituting withdrawal proceedings -- what the statute mandates -- is too time consuming is both ironic and arbitrary. Had the Agency addressed the Petitions in a timely fashion, withdrawal proceedings could have been commenced and completed by now.

To be clear, Judge Katz is not telling the FDA that it has to ban growth promoters; he is telling the agency to follow through on its own process, which started in 1977 with the agency itself advancing the possibility of a ban. There's surely more to come on this, given the FDA's appeal of the summary judgment on the first claim. Meanwhile, here are early reactions from both sides of the dispute.

From NRDC attorney Avinash Kar, via an NRDC statement:

The Court’s order pushes the agency one step closer to meaningful action to curb the dangerous overuse of antibiotics in animal feed. The Court calls out FDA’s protracted foot-dragging on the problem of antibiotic resistance and requires the agency do its job to protect our food, our health and our families.

From Ron Phillips, vice president of legislative and public affairs at the Animal Health Institute, which has pressed for voluntary action:

The court has now ordered FDA to initiate two different, competing and resource intensive processes... [S]cientific assessments come to the same conclusion: The actual human health risk of the use of antibiotic use in animals resulting in the inability of the drug to treat human disease is extremely small -- in one instance, less than the risk of dying from a bee sting.

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