A federal court ruled today that FDA cannot sidestep a decision on whether the use of medically important antibiotics in animal feed is shown to be safe for human health. This decision adds to the building momentum to end the unsafe use of antibiotics in livestock. In our landmark March win, the Court required FDA to withdraw approval for the use of penicillin and tetracyclines in animal feed unless drug manufacturers proved that such uses are safe.
Today, the Court directed FDA to reexamine its decision to deny two Citizen Petitions filed in 1999 and 2005, which asked the FDA to stop the unnecessary use of medically important antibiotics on livestock. The Court wrote:
“[T]he statutory scheme requires the Agency to ensure the safety and effectiveness of all drugs sold in interstate commerce, and, if an approved drug is not shown to be safe or effective, the Agency must begin withdrawal proceedings. The Agency has forsaken these obligations in the name of a proposed voluntary program, Guidance # 209, and acted contrary to the statutory language.
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[FDA] must evaluate the safety risks of the petitioned drugs and either make the 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.”
The Citizen Petitions asked FDA to act on medically important antibiotics that are being fed to healthy livestock and are contributing to the looming public health crisis of antibiotic resistance. Antibiotic resistance can lead to longer illnesses, the use of antibiotics with greater side effects, and even death when treatments fail. Almost seventy percent of all antibiotics sold in the US are used on healthy livestock, to promote faster weight gain and compensate for unsanitary, crowded conditions. Yet, in the face of the rising public health threat of antibiotic resistance, the FDA has largely failed to act. This is in spite of the fact that, as the Court notes, “the Agency has all but made a finding that the subtherapeutic use of antibiotics in food-producing animals has not been shown to be safe.”
The Petitions cover five classes of antibiotics in addition to the two—penicillin and tetracyclines—implicated in the March decision from the Court. FDA denied the Citizen Petitions on the grounds that regulatory action would require too much time and too many resources and that FDA was focusing instead on an alternative strategy of encouraging voluntary industry action.
The Court ruled that it was unlawful for FDA to deny the petitions on grounds that are not outlined in the law---things other than the safety and effectiveness of the antibiotic uses covered by the Petitions. As the Court said, “The adoption of voluntary measures does not excuse the Agency from its duty to review the Citizen Petitions on their merits.” In other words, follow the law.
FDA’s preferred voluntary approach suffers from a number of flaws, starting with the fact that it is voluntary. I detail some of those problems here, including that it will allow many of the same uses to continue under a different name and that these uses are not really necessary. The voluntary approach also suffers from a serious logical flaw that the Court points out. FDA says it prefers the voluntary approach because the regulatory approach would take too much time and resources. But, as the Court writes, “if any credence is to be given to the Agency’s position that the drug industry intends to comply with the voluntary program, then it is unclear why the industry would contest formal withdrawal notices or require time consuming hearings.” The Court also called FDA’s position “ironic and arbitrary,” saying “had the Agency addressed the Petitions in a timely fashion, withdrawal proceedings could have been commenced and completed by now.”
FDA’s unlawful denial of the Petitions followed years of foot-dragging. The Petitions had been pending before FDA for 12 and 6 years respectively when we initiated the lawsuit, and NRDC and its partners initially sued for unreasonable delay. FDA then tried to get rid of the lawsuit by denying the Petitions, as it turns out, on unlawful grounds.
The decade-plus delay on the Citizen Petitions follows three-plus decades of inaction on the use of penicillin and tetracyclines in animal feed, which FDA determined is not shown to be safe for human health—back in 1977. The Court’s decision today highlights FDA’s continual foot-dragging on this issue for the better part of four decades. “For over thirty years, the Agency has been confronted with evidence of the human health risks associated with the widespread subtherapeutic 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.”
The FDA has appealed the March decision from the Court and has trotted out a series of excuses, diversions, and evasions (see here, here, and here), including the misleading statement that the Petitions cover 161 drug products. As the Court notes, and as I have pointed out before, FDA would only need to hold a handful of hearings (not 161) to address those drug products.
Following the ruling, FDA must heed the science and make a decision about whether feeding antibiotics to healthy animals is safe for human health. If FDA determines that such use is not safe, it must withdraw approval for the use of the antibiotics in animal feed. It is high time for FDA to stop making excuses and trying to dodge its responsibilities. Its mandate is a weighty one—to protect public health—and it’s time for FDA to start living up to that mandate.